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CompletedNCT03276221Updated Feb 1, 2024Results posted

Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

An interventional study of Abstinence in Cannabis Use, Cognitive Change and Adolescent Behavior, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 10 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
10 Years to 19 Years
Sex
All
01

Study summary

This study will use a randomized controlled design to test whether 30 days of cannabis abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive functioning. Non-using controls will also be enrolled to determine the clinical significance of any cognitive improvements with abstinence.

Read the detailed description

This is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine (1) if performance improves with abstinence beyond that observed with continued cannabis use, and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether performance in abstinent individuals "returns" to performance levels observed in non-using peers. We hypothesized that abstinent adolescent cannabis users would have more neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and performance would continuously improve throughout four weeks of abstinence. We will recruit 210 adolescents with and without regular cannabis use. Eligible cannabis users will be randomized to either a contingency management intervention which will incentivize 4 weeks of cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n = 70). All participants (including non-users; n = 70) will complete cognitive assessments, toxicology testing, self-report questionnaires and semi-structured mood and substance use interviews during the 4-week study as well as one 30-day follow-up visit. Abstinence will be indexed by decreasing levels of cannabis metabolites in urine.

02

Conditions studied

  • Cannabis Use
  • Cognitive Change
  • Adolescent Behavior

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03

Who can participate

Ages eligible
10 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

General Inclusion Criteria for School-Aged Study Component:

  • Male and female adolescents from the Boston area who are between the ages of 10 and 19 (inclusive);
  • Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
  • Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
  • Competent and able to provide written informed consent (if age 18 or older)
  • Able to communicate in English language
  • Able to commit to 9 study visits in approximately 60 days
  • No severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome)
  • Able to safely participate in the protocol and appropriate for outpatient level of care

Cannabis-Using Group Inclusion Criteria:

  • Use of cannabis at least once per week on most weeks
  • Cannabis use reported within 7 days of both baseline visits
  • No immediate plan to discontinue cannabis use

Non-Using Group Inclusion Criteria:

  • Use of cannabis less than 5 times in lifetime
  • No cannabis use in the past year
  • No cannabis use before age 16

Exclusion Criteria for School-Aged Study Component

  • Passive consent for initial school-wide assessment withdrawn by parent or legal guardian or written parental consent not provided prior to screening
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
201 participants (actual)

Study arms

  • Active comparator
    Abstinent

    This group of cannabis users are agree to remain abstinent from cannabis use for 30 days.

    Behavioral: Abstinence

  • No intervention
    Monitoring

    This group of cannabis users are not asked to change their cannabis use behavior.

  • No intervention
    Non-Users

    This is a group of adolescents with little to no cannabis use history and is non-randomized.

Interventions

  • BehavioralAbstinence

    Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.

    Also known as: Contingency Management

05

What researchers measure

Primary outcomes

  1. Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4

    The number of times the subject chose the incorrect box for a stimulus on assessment problems plus an adjustment for the estimated number of errors they would have made on any problems/attempts/recalls they did not reach. This is a specific measure from the Paired Associates Learning (PAL) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The PAL module assesses visual memory and new learning. Count variable, ranging from 0 to 70, where higher scores indicate more errors and worse performance.

    Time frame: 1, 2, 3, and 4 Weeks

  2. Mean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4

    The number of times a subject chose the correct box on their first attempt when recalling pattern locations, which was calculated across all trials. This is a specific measure from the Paired Associates Learning (PAL) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The PAL module assesses visual memory and new learning. Count variable, ranging from 0 to 20, where higher scores indicate better memory performance.

    Time frame: 1, 2, 3, and 4 Weeks

  3. Mean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4

    The longest length of sequences (spans) a subject successfully remembered in the original order. This is a specific measure from the Spatial Span (SSP) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SSP assesses visuospatial working memory capacity. Count variable, ranging from 2 to 9, with higher scores indicating better memory performance.

    Time frame: 1, 2, 3, and 4 Weeks

  4. Mean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4

    The longest length of sequences (spans) a subject successfully remembered in the reverse order. This is a specific measure from the Spatial Span (SSP) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SSP assesses visuospatial working memory capacity. Count variable, ranging from 2 to 9, with higher scores indicating better memory performance.

    Time frame: 1, 2, 3, and 4 Weeks

  5. Mean Difference in the Total Number Correct in the Immediate Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

    The total number of distinct words a subject correctly recalled from the studied list of 18 words during the immediate free recall phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 18, with higher scores indicating better immediate recall performance.

    Time frame: 1, 2, 3, and 4 Weeks

  6. Mean Difference in the Total Number Correct in the Delayed Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

    The total number of distinct words a subject correctly recalled from the studied list of 18 words during the delayed free recall phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 18, with higher scores indicating better immediate recall performance.

    Time frame: 1, 2, 3, and 4 Weeks

  7. Mean Difference in the Total Number Correct in the Immediate Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

    The total number of words a subject correctly identified as either previously studied or novel during the immediate recognition phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 36, with higher scores indicating better recognition memory performance.

    Time frame: 1, 2, 3, and 4 Weeks

  8. Mean Difference in the Total Number Correct in the Delayed Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

    The total number of words a subject correctly identified as either previously studied or novel during the delayed recognition phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 36, with higher scores indicating better recognition memory performance.

    Time frame: 1, 2, 3, and 4 Weeks

  9. Mean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

    The total number of words a subject correctly identified as either previously studied or novel during the delayed recognition phase. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Count variable, ranging from 0 to 160, with higher scores indicating more errors and worse performance.

    Time frame: 1, 2, 3, and 4 Weeks

  10. Mean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

    The response latency for each participant was defined as a summary (median) computed over their response times for all correct responses irrespective of condition. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Response time variable in milliseconds (ms), ranging from 100 to 2000 ms, with higher values indicating slower performance across all trials.

    Time frame: 1, 2, 3, and 4 Weeks

  11. Mean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

    The incongruency cost for each participant was defined as a summary (median) of response times for incongruent trials minus a summary (median) of response times for congruent trials. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Difference score in milliseconds (ms), ranging from -1900 to 1900 ms, with higher values indicating slower responses on incongruent trials, suggesting that it takes longer to process conflicting information.

    Time frame: 1, 2, 3, and 4 Weeks

  12. Mean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

    The multitasking cost for each participant was defined as a summary (median) of response times for the multi-task blocks (trials alternated between having to respond to the direction or position of the arrow) minus a summary (median) of response times for the single-task blocks (all trials consisted of either responding to the direction or position of the arrow). This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Difference score in milliseconds (ms), ranging from -1900 to 1900 ms, with higher values indicating slower responses on multi-task blocks, suggesting that it takes longer to process multiple sources of information.

    Time frame: 1, 2, 3, and 4 Weeks

  13. Mean Difference in Number of Problems Correctly Solved on the First Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4

    The total number of trials where the subject chose the correct answer on the first attempt. This is a specific measure from the One Touch Stockings of Cambridge (OTS) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The OTS module assesses executive function based upon the Tower of Hanoi test. Count variable, ranging from 0 to 15, with higher scores indicating better performance.

    Time frame: 1, 2, 3, and 4 Weeks

  14. Mean Difference in the Latency to First Correct Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4

    The latency to first correct choice for each participant was defined as a summary (median) of the response times for all trials in which the subject picked the correct choice on the first attempt. This is a specific measure from the One Touch Stockings of Cambridge (OTS) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The OTS module assesses executive function based upon the Tower of Hanoi test. Response time variable in milliseconds (ms), a positive unbounded variable, with higher values indicating slower performance across correct trials.

    Time frame: 1, 2, 3, and 4 Weeks

  15. Mean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4

    The estimate of the duration at which a person can successfully inhibit a response 50% of the time, represents the time before which all actions become ballistic and a subject is unable to cancel a response selection. This is a specific measure from the Stop Signal Task (SST) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SST module assesses response inhibition (impulse control). Response time variable in milliseconds (ms), ranging from 0 to 500 ms, with higher values indicating that it takes longer for a person to inhibit a response.

    Time frame: 1, 2, 3, and 4 Weeks

  16. Mean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4

    The number of times a subject incorrectly revisited a box that had contained a token in a previous trial across the 4, 6, and 8 box conditions. This is a specific measure from the Spatial Working Memory (SWM) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SWM module provides a measure of strategy as well as working memory errors. Count variable, ranging from 0 to 63, with higher scores indicating worse performance.

    Time frame: 1, 2, 3, and 4 Weeks

  17. Mean Difference in the Participant's Strategy for 6-8 Box Conditions From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4

    The number of times subjects began a new search from the same box they started on in previous trials. It is assumed that a person who begins from the same box each time is using a planned strategy to find the tokens. This is a specific measure from the Spatial Working Memory (SWM) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SWM module provides a measure of strategy as well as working memory errors. Count variable, ranging from 2 to 14, with higher scores indicating low strategy, meaning a subject began searches from many different boxes.

    Time frame: 1, 2, 3, and 4 Weeks

Secondary outcomes

  1. Mean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4

    A transformation of the proportion of hits and false alarms, providing an estimate of a subject's ability to detect the target sequences of digits after controlling for response bias (i.e., biases to respond or not respond irrespective of the stimuli on screen). This is a specific measure from the Rapid Visual Information Processing (RVP) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The RVP module assesses sustained attention. Bounded continuous variable, ranging from 0 to 1, where higher scores indicate a greater ability to discriminate between targets and distractors.

    Time frame: 1, 2, 3, and 4 Weeks

  2. Mean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4

    The response latency for hits for each participant was defined as a summary (median) over the set of response times for all correct responses (identification of target 3-digit sequences). This is a specific measure from the Rapid Visual Information Processing (RVP) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The RVP module assesses sustained attention. Response time variable in milliseconds (ms), ranging from 100 to 1900 ms, with higher values indicating slower performance in detecting targets.

    Time frame: 1, 2, 3, and 4 Weeks

06

Results

Posted Feb 1, 2024
Limitations and caveats
Due to the constraints of the COVID-19 pandemic, approximately 6% of all study visits were conducted virtually. Visits were conducted remotely for one of the following reasons: the study site was closed due to hospital policy, the participant tested positive for COVID-19, or they endorsed a COVID-19-related symptom before the study visit. We believe this is a minor limitation of our study since administering the cognitive assessments virtually could have affected data collection.

Participant flow

Recruitment was conducted from 2017 to 2022.

Participant flow — Overall Study
MilestoneAbstinentMonitoringNon-Users
Started646869
Completed546669
Not completed1020
Withdrew: Lost to follow-up620
Withdrew: Did not abstain from cannabis as per protocol400

Outcome measures

PrimaryMean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4

The number of times the subject chose the incorrect box for a stimulus on assessment problems plus an adjustment for the estimated number of errors they would have made on any problems/attempts/recalls they did not reach. This is a specific measure from the Paired Associates Learning (PAL) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The PAL module assesses visual memory and new learning. Count variable, ranging from 0 to 70, where higher scores indicate more errors and worse performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number of Errors From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 45.6 ± 6.46.2 ± 7.75.9 ± 8.1
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.215 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.) · Slope: -0.19The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).
PrimaryMean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4

The number of times a subject chose the correct box on their first attempt when recalling pattern locations, which was calculated across all trials. This is a specific measure from the Paired Associates Learning (PAL) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The PAL module assesses visual memory and new learning. Count variable, ranging from 0 to 20, where higher scores indicate better memory performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in First Attempt Memory Score From Paired Associates Learning (PAL) Module Averaged Over Weeks 1, 2, 3, and 416.2 ± 3.215.8 ± 3.416.1 ± 3.6
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.495 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.) · Slope: 0.10The estimate is the mean difference in the log probability of picking the correct box for the abstinence group above and beyond the monitoring group (positive values indicate better memory performance for the abstinence group).
PrimaryMean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4

The longest length of sequences (spans) a subject successfully remembered in the original order. This is a specific measure from the Spatial Span (SSP) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SSP assesses visuospatial working memory capacity. Count variable, ranging from 2 to 9, with higher scores indicating better memory performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in Forward Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 47.6 ± 1.37.4 ± 1.37.6 ± 1.4
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.050 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.) · Slope: 0.28The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).
PrimaryMean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4

The longest length of sequences (spans) a subject successfully remembered in the reverse order. This is a specific measure from the Spatial Span (SSP) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SSP assesses visuospatial working memory capacity. Count variable, ranging from 2 to 9, with higher scores indicating better memory performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in Reverse Span Length From Spatial Span (SSP) Module Averaged Over Weeks 1, 2, 3, and 46.9 ± 1.47 ± 1.56.9 ± 1.6
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.532 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.) · Slope: -0.07The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).
PrimaryMean Difference in the Total Number Correct in the Immediate Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

The total number of distinct words a subject correctly recalled from the studied list of 18 words during the immediate free recall phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 18, with higher scores indicating better immediate recall performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number Correct in the Immediate Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number Correct in the Immediate Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 47.3 ± 2.37.3 ± 2.57.7 ± 2.7
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.226 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.) · Slope: 0.09The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).
PrimaryMean Difference in the Total Number Correct in the Delayed Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

The total number of distinct words a subject correctly recalled from the studied list of 18 words during the delayed free recall phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 18, with higher scores indicating better immediate recall performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number Correct in the Delayed Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number Correct in the Delayed Recall Measure From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 46.5 ± 2.86.5 ± 37.2 ± 3.1
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.369 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.) · Slope: 0.08The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).
PrimaryMean Difference in the Total Number Correct in the Immediate Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

The total number of words a subject correctly identified as either previously studied or novel during the immediate recognition phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 36, with higher scores indicating better recognition memory performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number Correct in the Immediate Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number Correct in the Immediate Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 432.3 ± 2.132.4 ± 2.931.9 ± 3.1
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.647 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.) · Slope: 0.05The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).
PrimaryMean Difference in the Total Number Correct in the Delayed Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4

The total number of words a subject correctly identified as either previously studied or novel during the delayed recognition phase. This is a specific measure from the Verbal Recognition Memory (VRM) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The VRM module assesses verbal memory and new learning. Count variable, ranging from 0 to 36, with higher scores indicating better recognition memory performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number Correct in the Delayed Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number Correct in the Delayed Recognition Condition From the Verbal Recognition Memory (VRM) Module Averaged Over Weeks 1, 2, 3, and 430.5 ± 330.9 ± 3.630.3 ± 4
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.511 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.) · Slope: -0.06The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).
PrimaryMean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

The total number of words a subject correctly identified as either previously studied or novel during the delayed recognition phase. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Count variable, ranging from 0 to 160, with higher scores indicating more errors and worse performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number Incorrect From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 47.1 ± 5.68.5 ± 7.79.1 ± 8.1
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.312 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.) · Slope: -0.12The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).
PrimaryMean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

The response latency for each participant was defined as a summary (median) computed over their response times for all correct responses irrespective of condition. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Response time variable in milliseconds (ms), ranging from 100 to 2000 ms, with higher values indicating slower performance across all trials.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Response Latency From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4474 ± 72468 ± 78482 ± 86
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.836 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.) · Slope: 1.92The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate higher slower responses for the abstinence group).
PrimaryMean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

The incongruency cost for each participant was defined as a summary (median) of response times for incongruent trials minus a summary (median) of response times for congruent trials. This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Difference score in milliseconds (ms), ranging from -1900 to 1900 ms, with higher values indicating slower responses on incongruent trials, suggesting that it takes longer to process conflicting information.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Incongruency Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 437 ± 3340 ± 3243 ± 37
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.898 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.) · Slope: -0.50The estimate is the mean difference in the median incongruency cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for incongruent trials for the abstinence group).
PrimaryMean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4

The multitasking cost for each participant was defined as a summary (median) of response times for the multi-task blocks (trials alternated between having to respond to the direction or position of the arrow) minus a summary (median) of response times for the single-task blocks (all trials consisted of either responding to the direction or position of the arrow). This is a specific measure from the Multitasking Test (MTT) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The MTT assesses the participant's ability to manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task-irrelevant information. Difference score in milliseconds (ms), ranging from -1900 to 1900 ms, with higher values indicating slower responses on multi-task blocks, suggesting that it takes longer to process multiple sources of information.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Multitasking Cost From the Multitasking Test (MTT) Module Averaged Over Weeks 1, 2, 3, and 496 ± 7171 ± 6881 ± 81
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.068 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.) · Slope: 16.54The estimate is the mean difference in the multitasking cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for multitasking trials for the abstinence group).
PrimaryMean Difference in Number of Problems Correctly Solved on the First Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4

The total number of trials where the subject chose the correct answer on the first attempt. This is a specific measure from the One Touch Stockings of Cambridge (OTS) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The OTS module assesses executive function based upon the Tower of Hanoi test. Count variable, ranging from 0 to 15, with higher scores indicating better performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in Number of Problems Correctly Solved on the First Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in Number of Problems Correctly Solved on the First Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 412.2 ± 1.811.5 ± 2.311.5 ± 2.7
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.150 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.) · Slope: 0.15The estimate is the mean difference in the log probability of making a correct response for the abstinence group above and beyond the monitoring group (positive values indicate higher accuracy for the abstinence group).
PrimaryMean Difference in the Latency to First Correct Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4

The latency to first correct choice for each participant was defined as a summary (median) of the response times for all trials in which the subject picked the correct choice on the first attempt. This is a specific measure from the One Touch Stockings of Cambridge (OTS) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The OTS module assesses executive function based upon the Tower of Hanoi test. Response time variable in milliseconds (ms), a positive unbounded variable, with higher values indicating slower performance across correct trials.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Latency to First Correct Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Latency to First Correct Choice From the One Touch Stockings of Cambridge (OTS) Module Averaged Over Weeks 1, 2, 3, and 47036 ± 27946690 ± 22836851 ± 3183
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.525 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.) · Slope: 179.11The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).
PrimaryMean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4

The estimate of the duration at which a person can successfully inhibit a response 50% of the time, represents the time before which all actions become ballistic and a subject is unable to cancel a response selection. This is a specific measure from the Stop Signal Task (SST) Module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SST module assesses response inhibition (impulse control). Response time variable in milliseconds (ms), ranging from 0 to 500 ms, with higher values indicating that it takes longer for a person to inhibit a response.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in Stop Signal Reaction Time From Stop Signal Task (SST) Module Averaged Over Weeks 1, 2, 3, and 4210 ± 35219 ± 49222 ± 56
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.038 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the stop signal task module. The a priori threshold for statistical significance was 0.05.) · Slope: -10.86The estimate is the mean difference in the inhibition latency for the abstinence group above and beyond the monitoring group (positive values indicate slower inhibition for the abstinence group).
PrimaryMean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4

The number of times a subject incorrectly revisited a box that had contained a token in a previous trial across the 4, 6, and 8 box conditions. This is a specific measure from the Spatial Working Memory (SWM) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SWM module provides a measure of strategy as well as working memory errors. Count variable, ranging from 0 to 63, with higher scores indicating worse performance.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Total Number of Between Errors From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 43.6 ± 5.44.6 ± 6.35.5 ± 7.7
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.576 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.) · Slope: -0.10The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).
PrimaryMean Difference in the Participant's Strategy for 6-8 Box Conditions From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4

The number of times subjects began a new search from the same box they started on in previous trials. It is assumed that a person who begins from the same box each time is using a planned strategy to find the tokens. This is a specific measure from the Spatial Working Memory (SWM) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The SWM module provides a measure of strategy as well as working memory errors. Count variable, ranging from 2 to 14, with higher scores indicating low strategy, meaning a subject began searches from many different boxes.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Participant's Strategy for 6-8 Box Conditions From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Participant's Strategy for 6-8 Box Conditions From the Spatial Working Memory (SWM) Module Averaged Over Weeks 1, 2, 3, and 45.4 ± 2.65.7 ± 2.66.1 ± 2.7
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.296 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.) · Slope: -0.15The estimate is the mean difference in the log probability of trials with strategic responding for the abstinence group above and beyond the monitoring group (positive values indicate higher rates of strategic responding for the abstinence group).
SecondaryMean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4

A transformation of the proportion of hits and false alarms, providing an estimate of a subject's ability to detect the target sequences of digits after controlling for response bias (i.e., biases to respond or not respond irrespective of the stimuli on screen). This is a specific measure from the Rapid Visual Information Processing (RVP) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The RVP module assesses sustained attention. Bounded continuous variable, ranging from 0 to 1, where higher scores indicate a greater ability to discriminate between targets and distractors.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Measure of Discriminability - A' From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 40.94 ± 0.050.93 ± 0.060.92 ± 0.08
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.650 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.) · Slope: 0.00The estimate is the mean difference in the discriminability measure for the abstinence group above and beyond the monitoring group (positive values indicate higher discriminability rates for the abstinence group).
SecondaryMean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4

The response latency for hits for each participant was defined as a summary (median) over the set of response times for all correct responses (identification of target 3-digit sequences). This is a specific measure from the Rapid Visual Information Processing (RVP) module, which is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The RVP module assesses sustained attention. Response time variable in milliseconds (ms), ranging from 100 to 1900 ms, with higher values indicating slower performance in detecting targets.

Time frame:
1, 2, 3, and 4 Weeks
Reported as:
Mean · score on a scale
Mean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4
score on a scaleAbstinentMonitoringNon-Users
Mean Difference in the Reponse Latency for Hits From the Rapid Visual Information Processing (RVP) Module Averaged Over Weeks 1, 2, 3, and 4422 ± 51428 ± 97428 ± 78
Statistical analysis
  • Abstinent vs Monitoring · Mixed Models Analysis · p = 0.223 (The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.) · Slope: -11.64The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate slower responses for the abstinence group).

Adverse events

Collected over Adverse event data was collected over 60 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Abstinent0/54 (0%)0/54 (0%)49/54 (90.7%)
Monitoring0/66 (0%)0/66 (0%)46/66 (69.7%)
Non-Users0/69 (0%)0/69 (0%)31/69 (44.9%)
Most frequent other events
Most frequent other events
EventAbstinentMonitoringNon-Users
General disordersGeneral disorders45/5434/6621/69
Psychiatric DisordersPsychiatric disorders26/5411/666/69
Respiratory, Thoracic and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders3/547/667/69
Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders5/544/661/69
Injury, Poisoning and Procedural ComplicationsInjury, poisoning and procedural complications1/546/662/69
Gastrointestinal disordersGastrointestinal disorders1/545/661/69

Baseline characteristics

Age, Continuous
Age, Continuous(years)AbstinentMonitoringNon-UsersTotal
Mean18.3 ± 1.418.1 ± 1.517.0 ± 1.817.8 ± 1.7
Sex: Female, Male
Sex: Female, Male(Participants)AbstinentMonitoringNon-UsersTotal
Female26314097
Male28352992
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)AbstinentMonitoringNon-UsersTotal
Hispanic or Latino516930
Not Hispanic or Latino495060159
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AbstinentMonitoringNon-UsersTotal
American Indian or Alaska Native1102
Asian47617
Native Hawaiian or Other Pacific Islander0000
Black or African American10101434
White313439104
More than one race611421
Unknown or Not Reported23611
Region of Enrollment
Region of Enrollment(participants)AbstinentMonitoringNon-UsersTotal
United States546669189
APSS
APSS(Score on a scale)AbstinentMonitoringNon-UsersTotal
Mean0.1 ± 0.60.3 ± 0.80.1 ± 0.50.2 ± 0.7
PQB
PQB(Score on a scale)AbstinentMonitoringNon-UsersTotal
Mean2.9 ± 3.73.8 ± 3.81.8 ± 2.32.8 ± 3.4
Years Spent Using Cannabis
Years Spent Using Cannabis(years)AbstinentMonitoringNon-UsersTotal
Mean3.3 ± 1.33.4 ± 1.50 ± 03.4 ± 1.4

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Publications

  • Cooke ME, Gilman JM, Lamberth E, Rychik N, Tervo-Clemmens B, Evins AE, Schuster RM. Assessing Changes in Symptoms of Depression and Anxiety During Four Weeks of Cannabis Abstinence Among Adolescents. Front Psychiatry. 2021 Jul 1;12:689957. doi: 10.3389/fpsyt.2021.689957. eCollection 2021. PubMed 34276449 ↗
  • Savulich G, Rychik N, Lamberth E, Hareli M, Evins AE, Sahakian BJ, Schuster RM. Sex Differences in Neuropsychological Functioning are Domain-Specific in Adolescent and Young Adult Regular Cannabis Users. J Int Neuropsychol Soc. 2021 Jul;27(6):592-606. doi: 10.1017/S1355617720001435. PubMed 34261559 ↗
  • Schuster RM, Gilman J, Schoenfeld D, Evenden J, Hareli M, Ulysse C, Nip E, Hanly A, Zhang H, Evins AE. One Month of Cannabis Abstinence in Adolescents and Young Adults Is Associated With Improved Memory. J Clin Psychiatry. 2018 Oct 30;79(6):17m11977. doi: 10.4088/JCP.17m11977. PubMed 30408351 ↗
  • Schuster RM, Potter K, Lamberth E, Rychik N, Hareli M, Allen S, Broos HC, Mustoe A, Gilman JM, Pachas G, Evins AE. Alcohol substitution during one month of cannabis abstinence among non-treatment seeking youth. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110205. doi: 10.1016/j.pnpbp.2020.110205. Epub 2020 Dec 9. PubMed 33309538 ↗
  • Schuster RM, Potter K, Vandrey R, Hareli M, Gilman J, Schoenfeld D, Evins AE. Urinary 11-nor-9-carboxy-tetrahydrocannabinol elimination in adolescent and young adult cannabis users during one month of sustained and biochemically-verified abstinence. J Psychopharmacol. 2020 Feb;34(2):197-210. doi: 10.1177/0269881119872206. Epub 2019 Sep 19. PubMed 31535597 ↗

Study documents

  • Study protocol · Aug 10, 2023
  • Statistical analysis plan · Apr 28, 2023
  • Informed consent form · Sep 21, 2023

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03276221
Lead sponsor
Massachusetts General Hospital
Responsible party
Randi Melissa Schuster (Associate Professor, Massachusetts General Hospital) — Principal investigator
First posted
Sep 8, 2017
Start date
Aug 7, 2017
Primary completion
Nov 9, 2022
Completion
Nov 9, 2022
Results posted
Feb 1, 2024
Last update
Feb 1, 2024

Study contacts

Randi M Schuster, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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