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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 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.

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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.

Conditions Studied

Alcohol Use Disorder

Interventions

  • OTHER Placebo
  • DRUG Phytocannabinoid cannabidiol (CBD)

Study Locations (1)

New York

  • New York University School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2019-09-01
Est. Completion 2022-03-16
Phase Phase 1

Sponsor

NYU Langone Health

1,164 total trials

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What the Registry Record Tells You About NCT03252756

The ClinicalTrials.gov registry entry for NCT03252756 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (92% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.