CompletedNCT03655717fNIRSUpdated Jul 28, 2022Results posted

Using Imaging to Assess Effects of THC on Brain Activity

An interventional study of Dronabinol and Ethanol in Intoxication Alcohol, Intoxication THC and Intoxication Combined Alcohol THC, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-28.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 316
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This study will assess effects of tetrahydrocannabinol (THC) and THC + alcohol in marijuana users on prefrontal brain activity, using functional near-infrared spectroscopy (fNIRS) during resting state and during memory task performance. Participants will complete fNIRS testing 120 minutes following THC or identical placebo (Phase 2A), or THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol (Phase 2B), and oxygenated hemoglobin (HbO) concentration will be measured.

Read the detailed description

This study will assess the effects of THC intoxication using dronabinol (synthetic THC) on the oxyhemoglobin (HbO) signal during resting state and task-based activation in the prefrontal cortex (PFC) and resting state connectivity, as well as on neurocognitive task performance and correlations between these measurements and clinical signs of intoxication. Participants will be 150 adults who use marijuana at least monthly (aged 18-55) will be recruited to participate in this study. Participants will be given up to 80 mg of dronabinol, an FDA-approved synthetic form of THC that is used to treat loss of appetite that causes weight loss in people with AIDS. THC is the principle psychoactive drug in marijuana. The study will be conducted in regular cannabis users who present at their first study visit with a positive urine screen for THC metabolites.

Phase 2A. Investigate the effect of THC on fNIRS brain signature and its association with self-reported intoxication, laboratory measures of impairment, and the gold-standard behavioral field test of driving impairment used by law enforcement, the primary classifier.

Phase 2B. Examine potential interaction following co-administration of THC with oral ethanol exposure in healthy volunteers. Phase II is a randomized, double-blind, placebo-controlled, 2 by 2 crossover study of effect of dronabinol, ethanol, and combined dronabinol and ethanol on brain activation and connectivity as measured by fNIRS.

Conditions studied

Intoxication Alcohol
Intoxication THC
Intoxication Combined Alcohol THC

Browse trials for

Alcoholic Intoxication 76

Keywords

fNIRS
THC
Intoxication

In context

Alcoholic Intoxication

76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.

This study's enrollment of 316 is above the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.

Browse Alcoholic Intoxication studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Browse Massachusetts General Hospital studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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.

Inclusion criteria

Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive)
Competent and willing to provide written ;
Able to communicate in English language.
Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC
Additional Inclusion Criteria For Phase 2B:
Past consumption of at least two alcoholic beverages in one occasion.
Past co-consumption of alcohol and THC at least once in lifetime with no serious adverse effects.
Weigh more than 100 lbs.

Exclusion criteria

Exclusion Criteria:

General (Phase 2A, 2B 3)

Any unstable, serious medical illness, or cardiovascular disease or events.
New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder,
Diabetes, cirrhosis, renal failure, , ,
History of syncope without an identified situational stressor, migraines >1x/month, head injury with prolonged unconsciousness (> 24 hours);
Allergy to sesame oil (contained in Marinol pills) or Marinol capsules
Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents;
Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)
In the opinion of the investigator, not able to safely participate in this study.
Additional Exclusion Criteria For Phase 2B:
Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 316 participants (actual)

Study arms

Experimental
Phase 2A
In a double-blind placebo-controlled, random order cross-over study of single dose dronabinol, participants received dronabinol or identical placebo on two separate study visits in randomized order.
Drug: Dronabinol · Drug: Placebo dronabinol
Experimental
Phase 2B
In a randomized, double-blind, 4-treatment, 4-period, crossover study with THC or placebo administration and ethanol or placebo administration, participants were randomly assigned to 1 of 4 sequences and received each of the following treatments: placebo dronabinol + placebo ethanol, placebo dronabinol + ethanol, dronabinol + placebo ethanol, \& dronabinol + ethanol.
Drug: Dronabinol · Drug: Ethanol · Drug: Placebo dronabinol · Drug: Placebo ethanol

Interventions

DrugDronabinol
Dronabinol at physician determined doses of 10-80mg designed to produce intoxication.
Also known as: oral THC
DrugEthanol
Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).
Also known as: oral ethanol
DrugPlacebo dronabinol
Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)
Also known as: placebo oral THC
DrugPlacebo ethanol
Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.
Also known as: oral placebo ethanol

What researchers measure

Primary outcomes

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task.
Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).
Time frame: The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration.

Other outcomes

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State.
Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).
Time frame: The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration.

Results

Posted Jul 28, 2022

Limitations and caveats

After reviewing and updating the study record to appropriately reflect the approved protocol, it was determined that the entry for Study Phase is best represented as N/A, rather than Phase 4, as the purpose of the study is NOT to investigate the safety or efficacy of the drug. This study seeks to use dronabinol only to probe and describe brain physiology. The change from Phase 4 to N/A more accurately and reflects the IRB approved protocol, and the aims of the grant that funds the research.

Participant flow

Participants were recruited by study staff at the MGH Center for Addiction Medicine through advertising by email, web and bulletin board announcements posted within the local site network community.

Participant flow — Overall Study
Milestone	Phase 2A: AB	Phase 2A: BA	Phase 2B: CDEF	Phase 2B: CDFE	Phase 2B: CEFD	Phase 2B: CFDE	Phase 2B: CFED	Phase 2B: DCEF	Phase 2B: DCFE	Phase 2B: DECF	Phase 2B: DEFC	Phase 2B: DFCE	Phase 2B: DFEC	Phase 2B: ECDF	Phase 2B: ECFD	Phase 2B: EDCF	Phase 2B: EDFC	Phase 2B: EFCD	Phase 2B: EFDC	Phase 2B: FCDE	Phase 2B: FCED	Phase 2B: FDCE	Phase 2B: FDEC	Phase 2B: FECD	Phase 2B: FEDC
Started	70	68	2	1	3	3	3	2	1	1	3	2	3	2	2	2	2	3	3	2	3	2	4	1	2
Completed	60	56	1	0	1	0	2	0	0	1	1	2	0	2	1	2	2	2	2	2	2	0	2	0	2
Not completed	10	12	1	1	2	3	1	2	1	0	2	0	3	0	1	0	0	1	1	0	1	2	2	1	0
Withdrew: Withdrawal by subject	4	8	1	0	1	3	1	2	0	0	1	0	3	0	1	0	0	1	0	0	1	2	1	1	0
Withdrew: Physician decision	3	3	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0
Withdrew: Lost to follow-up	3	1	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Outcome measures

PrimaryChange in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task.

Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).

Time frame:: The first Nback scan session was run before dosing (t ≈ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ≈ 100min). Each scan session was six minutes in duration.
Reported as:: Mean · Δ mol/L

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task.
Δ mol/L	Phase 2A: Dronabinol Only	Phase 2A: Placebo Dronabinol Only	Phase 2B: Dronabinol and Ethanol	Phase 2B: Dronabinol and Placebo Ethanol	Phase 2B: Placebo Dronabinol and Ethanol	Phase 2B: Placebo Dronabinol and Placebo Ethanol
Predose	0.00000000042 ± 0.00000011109	-0.00000000126 ± 0.00000012928	-0.00000000271 ± 0.00000015932	-0.00000000114 ± 0.00000015048	-0.00000000151 ± 0.00000009318	-0.00000000219 ± 0.00000012507
Peak	0.00000000013 ± 0.00000010190	0.00000000029 ± 0.00000012394	-0.00000000041 ± 0.00000010552	-0.00000000020 ± 0.00000012457	-0.00000000018 ± 0.00000009089	0.00000000070 ± 0.00000011546

Statistical analysis

Phase 2A: Dronabinol Only vs Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Dronabinol and Placebo Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol · Regression, Linear · p = 0.94 (The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.) · Mean difference (final values): -0.038 · 95% CI -0.259 to 0.184Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).
Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol · Regression, Linear · p = 0.94 (The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.) · Mean difference (final values): -0.018 · 95% CI -0.421 to 0.386Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).
Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol · Regression, Linear · p = 0.94 (The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.) · Mean difference (final values): 0.016 · 95% CI -0.535 to 0.568Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).

Other pre-specifiedChange in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State.

Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).

Time frame:: The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration.
Reported as:: Mean · Δ mol/L

Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State.
Δ mol/L	Phase 2A: Dronabinol Only	Phase 2A: Placebo Dronabinol Only	Phase 2B: Dronabinol and Ethanol	Phase 2B: Dronabinol and Placebo Ethanol	Phase 2B: Placebo Dronabinol and Ethanol	Phase 2B: Placebo Dronabinol and Placebo Ethanol
Predose	-0.00000000056 ± 0.00000014233	0.00000000009 ± 0.00000011881	0.00000000198 ± 0.00000010153	0.00000000021 ± 0.00000015753	0.00000000144 ± 0.00000017047	-0.00000000051 ± 0.00000011795
Peak	-0.00000000043 ± 0.00000010544	0.00000000115 ± 0.00000014174	0.00000000025 ± 0.00000008717	0.00000000190 ± 0.00000013848	0.00000000195 ± 0.00000011273	-0.00000000014 ± 0.00000008289

Statistical analysis

Phase 2A: Dronabinol Only vs Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Dronabinol and Placebo Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol · Regression, Linear · p = 0.94 (The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.) · Mean difference (final values): -0.163 · 95% CI -0.384 to 0.057Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).
Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol · Regression, Linear · p = 0.94 (The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.) · Mean difference (final values): -0.176 · 95% CI -0.588 to 0.237Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).
Phase 2A: Placebo Dronabinol Only vs Phase 2B: Dronabinol and Ethanol vs Phase 2B: Placebo Dronabinol and Placebo Ethanol · Regression, Linear · p = 0.94 (The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.) · Mean difference (final values): 0.187 · 95% CI -0.354 to 0.728Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).

Adverse events

Collected over Participant enrollment to study completion, an average of 3 weeks for Phase 2A and 6 weeks for Phase 2B. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Phase 2A: Dronabinol Only	0/128 (0%)	0/128 (0%)	13/128 (10.2%)
Phase 2A: Placebo Dronabinol Only	0/126 (0%)	0/126 (0%)	6/126 (4.8%)
Phase 2B: Dronabinol and Ethanol	0/39 (0%)	0/39 (0%)	7/39 (17.9%)
Phase 2B: Dronabinol and Placebo Ethanol	0/39 (0%)	0/39 (0%)	12/39 (30.8%)
Phase 2B: Placebo Dronabinol and Ethanol	0/32 (0%)	0/32 (0%)	3/32 (9.4%)
Phase 2B: Placebo Dronabinol and Placebo Ethanol	0/38 (0%)	0/38 (0%)	4/38 (10.5%)

Most frequent other events

Most frequent other events
Event	Phase 2A: Dronabinol Only	Phase 2A: Placebo Dronabinol Only	Phase 2B: Dronabinol and Ethanol	Phase 2B: Dronabinol and Placebo Ethanol	Phase 2B: Placebo Dronabinol and Ethanol	Phase 2B: Placebo Dronabinol and Placebo Ethanol
AnxietyPsychiatric disorders	5/128	2/126	3/39	4/39	0/32	0/38
TachycardiaCardiac disorders	1/128	0/126	1/39	4/39	0/32	1/38
VomitingGastrointestinal disorders	2/128	2/126	1/39	3/39	1/32	1/38
ColdInfections and infestations	5/128	2/126	2/39	1/39	2/32	2/38

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Phase 2A - Total Sample	Phase 2B - Total Sample	Total
<=18 years	0	0	0
Between 18 and 65 years	138	52	190
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Phase 2A - Total Sample	Phase 2B - Total Sample	Total
Mean	24.9 ± 6.49	25.6 ± 5.16	25.1 ± 6.15

Sex: Female, Male
Sex: Female, Male(Participants)	Phase 2A - Total Sample	Phase 2B - Total Sample	Total
Female	67	27	94
Male	71	25	96

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Phase 2A - Total Sample	Phase 2B - Total Sample	Total
Hispanic or Latino	28	10	38
Not Hispanic or Latino	107	41	148
Unknown or Not Reported	3	1	4

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Phase 2A - Total Sample	Phase 2B - Total Sample	Total
American Indian or Alaska Native	2	0	2
Asian	11	2	13
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	16	6	22
White	93	36	129
More than one race	12	4	16
Unknown or Not Reported	4	4	8

Region of Enrollment
Region of Enrollment(participants)	Phase 2A - Total Sample	Phase 2B - Total Sample	Total
United States	138	52	190

Study locations

1 site

Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry
Boston, Massachusetts 02114, United States

References and documents

Publications

Gilman JM, Schmitt WA, Potter K, Kendzior B, Pachas GN, Hickey S, Makary M, Huestis MA, Evins AE. Identification of ∆9-tetrahydrocannabinol (THC) impairment using functional brain imaging. Neuropsychopharmacology. 2022 Mar;47(4):944-952. doi: 10.1038/s41386-021-01259-0. Epub 2022 Jan 8. Erratum In: Neuropsychopharmacology. 2022 May;47(6):1282. doi: 10.1038/s41386-022-01299-0. PubMed 34999737 ↗

Study documents

Study protocol ↗ · Mar 3, 2020
Statistical analysis plan ↗ · Apr 29, 2022
Informed consent form ↗ · Feb 15, 2022

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be available

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Jan 2021, 26 months.

Results were first posted in Jul 2022, 1 year 6 months after primary completion.

Of 29 interventional studies with no phase under Alcoholic Intoxication, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 58. This study's 26 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 20, 2018
First posted: Aug 31, 2018
StartActual: Nov 5, 2018
Primary completionActual: Jan 21, 2021
CompletionActual: Jan 21, 2021
Results first posted: Jul 28, 2022
Last update: Jul 28, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03655717
Lead sponsor: Massachusetts General Hospital
Collaborators: National Institute on Drug Abuse (NIDA)
Responsible party: A. Eden Evins (Director, Center for Addiction Medicine, Massachusetts General Hospital) — Principal investigator
First posted: Aug 31, 2018
Start date: Nov 5, 2018
Primary completion: Jan 21, 2021
Completion: Jan 21, 2021
Results posted: Jul 28, 2022
Last update: Jul 28, 2022

Study contacts

A. Eden Evins, MD, MPH

principal investigator · Massachusetts General Hospital

Jodi M Gilman, PhD

study director · 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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