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NCT03252756 · ClinicalTrials.gov registry record · Phase 1
Effects of Cannabidiol in Alcohol Use Disorder
A Phase 1 study of Alcohol Use Disorder, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT03252756: Completed Phase 1 study of Alcohol Use Disorder, sponsored by NYU Langone Health.
NCT03252756 is a Phase 1 study of Alcohol Use Disorder that has completed, run by NYU Langone Health. The registered enrollment target is 27 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03252756, a Phase 1 study of Alcohol Use Disorder, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of the proposed project is to begin rigorous study of the clinically relevant effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD to those of placebo in AUD patients. Participants with AUD will be randomized to receive either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and motoric function), and physiological and psychological domains relevant to AUD (including self-reported craving, depression, and anxiety, and responses to personalized scripts designed to elicit stress- and cue-induced craving and anxiety). Assessments will be conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs. placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
Primary Outcome
CBD "trough" plasma levels measured before dosing with CBD.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Phytocannabinoid cannabidiol (CBD)
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2022-03-16 |
| Phase | Phase 1 |
What the finished NCT03252756 record still lists
NCT03252756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03252756 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03252756 about?
NCT03252756 is a clinical study titled "Effects of Cannabidiol in Alcohol Use Disorder". The goal of the proposed project is to begin rigorous study of the clinically relevant effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is designed to assess feasibility an...
What is the current status of trial NCT03252756?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2019-09-01. Estimated completion is 2022-03-16.
What conditions does trial NCT03252756 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT03252756?
The interventions under investigation include: Placebo (OTHER), Phytocannabinoid cannabidiol (CBD) (DRUG).
Who is sponsoring clinical trial NCT03252756?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03252756 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03252756's enrollment target sits among peer trials
27 161st of 184 higher than 24 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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