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NCT03248167 · ClinicalTrials.gov registry record · Phase 1

Cannabidiol as a Treatment for AUD Comorbid With PTSD

A Phase 1 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by NYU Langone Health.

Completed
Registry status
Phase 1
Development phase
95
Enrollment target
1
Study location

NCT03248167: Completed Phase 1 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by NYU Langone Health.

NCT03248167 is a Phase 1 study of Post Traumatic Stress Disorder and Alcohol Use Disorder that has completed, run by NYU Langone Health. The registered enrollment target is 95 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03248167, a Phase 1 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 1
Development phase
95 participants
Enrollment target
1
Study location

Study Summary

This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts

Primary Outcome

Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.

Conditions Studied

Post Traumatic Stress Disorder Alcohol Use Disorder

Interventions

  • DRUG Cannabidiol
  • DRUG Placebos

Study Locations (1)

New York

  • New York University School of Medicine - New York

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2019-09-16
Est. Completion 2022-04-20
Phase Phase 1
NYU Langone Health

1,164 total trials

What the finished NCT03248167 record still lists

NCT03248167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (86% lower).

The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cannabidiol is the first listed.

NCT03248167 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03248167 about?

NCT03248167 is a clinical study titled "Cannabidiol as a Treatment for AUD Comorbid With PTSD". This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce ...

What is the current status of trial NCT03248167?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2019-09-16. Estimated completion is 2022-04-20.

What conditions does trial NCT03248167 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Alcohol Use Disorder.

What interventions are being tested in trial NCT03248167?

The interventions under investigation include: Cannabidiol (DRUG), Placebos (DRUG).

Who is sponsoring clinical trial NCT03248167?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03248167 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 Post Traumatic Stress 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 NCT03248167's enrollment target sits among peer trials

95 118th of 262 higher than 144 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03248167, the US trial registry maintained by the National Library of Medicine. NCT03248167 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.