Cannabidiol as a Treatment for AUD Comorbid With PTSD
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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 to produce hypothesized effects are relatively well-understood, results may
substantially advance understanding of the neurobiological basis of alcohol addiction.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health