An observational study in Cannabis Use, Cannabis Intoxication and Cannabis Use Disorder, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Boston Children's Hospital · Observational
The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-35 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits across \~ 3-4 weeks and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~ Day 7; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~ Day 28; TLFB interview, urine test, oral fluid test, survey, interview).
Individuals age 18-35 are invited to screen here: https://redcap.link/softa-bch
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 22, 2026. See what changed
Community sample
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Individuals age 18-35 are invited to screen here: https://redcap.link/softa-bch
Community sample of 200 younger adults aged 18-35 years who have used cannabis in the past 30 days at baseline, report use frequency of ≥1x/week at baseline, and have a positive test for urinary 11-nor-9-carboxy-delta-9-tetrocannabinol (THC-COOH) at the Day-7 visit
Other: Biologic testing for THC
Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.
Testing duration: self-testing
Duration in minutes of videos of self-testing
Time frame: Across 6 days leading up to the Day-28 visit
Testing duration: observed test
Duration in minutes of observed self-testing during study visit
Time frame: Day of/During the Day-28 visit
Oral fluid testing protocol adherence: self-testing completed
Number and percent of videos of self-testing completed
Time frame: Across 6 days leading up to the Day-28 visit
Oral fluid testing protocol adherence: observed test completed
Number and percent of live self-testing completed
Time frame: Day of/During the Day-28 visit
Oral fluid testing protocol adherence: testing steps performed
Number and percent of each step of self-testing performed (yes/no)
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Oral fluid testing protocol adherence: testing steps performed correctly
Number and percent of each step of self-testing performed correctly (yes/no)
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Unreadable test results
Number and percent of oral fluid tests with unreadable results
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Inconclusive test results
Number and percent of oral fluid tests with inconclusive results
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Oral fluid test results
Oral fluid test results for delta-9- tetrahydrocannabinol (delta-9-THC) on day of test (negative = non-use / positive = use)
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Oral fluid acceptability
Measure of acceptability (usability, likability, burden), 5 items, 5-point Likert-type scale (1, Strongly Disagree to 5, Strongly Agree), with higher score indicating greater acceptability. Benchmark for scale: ≥80% of participants with mean item score ≥4 out of 5
Time frame: Day-28 visit
Use/Non-use intervals of 4 days
Agreement between oral fluid results for 3 consecutive days (any positive = use / all negative = non-use) and self-report on timeline follow-back (TLFB) calendar interview for the same 3 days plus 1 day earlier (any days of use = use / no days of use = non-use). Benchmark: ≥ moderate agreement (Cohen's kappa ≥ 0.6)
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Use/Non-use
Agreement between oral fluid test results (positive/negative) and urine test result (positive/negative). Benchmarks: strong agreement (Cohen's kappa ≥ 0.8) for use; weak agreement (Cohen's kappa \< 0.6) for non-use
Time frame: Day-28 visit
Use/Non-use for intervals of 2-8 days
Agreement (use/non-use) between oral fluid test results and cannabis use reported on TLFB calendar interview for corresponding intervals ranging from 2 days (day of and day before testing, ≤24 hours prior) to 8 days
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Within-day frequency of cannabis use
Number of times cannabis used within each day included in the intervals being examined for agreement (Specific Aim 2A and 2B), reported on TLFB calendar interview
Time frame: Day-28 visit
Timing of cannabis use
Number of hours between last use and oral fluid testing time
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Plan to share: Yes — De-identified survey data and biologic test result data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: De-identified scientific data will be shared as soon as possible. De-identified scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.
Access criteria: De-identified scientific data and metadata arising from the project will be archived in the openICPSR repository. De-identified scientific data from this project will be findable through summary information (metadata) that will be readily available on the Center for Adolescent Behavioral Health Research website, the repository website, and clinicaltrials.gov.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Feb 2027 → Jun 2027 and completion May 2027 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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