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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 Alcohol Use Disorder and Post Traumatic Stress Disorder, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 1
- Study location
NCT03248167 is a Phase 1 study of Alcohol Use Disorder and Post Traumatic Stress Disorder that has completed, run by NYU Langone Health. The registered enrollment target is 95 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03248167, a Phase 1 study of Alcohol Use Disorder and Post Traumatic Stress 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
Conditions Studied
Interventions
- DRUG Cannabidiol
- DRUG Placebos
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2022-04-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03248167
The ClinicalTrials.gov registry entry for NCT03248167 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 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 (71% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cannabidiol is the first listed.
NCT03248167 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Alcohol Use Disorder, Post Traumatic Stress 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.
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