Cannabidiol as a Treatment for AUD Comorbid With PTSD
Condition: Alcohol Use Disorder; Post Traumatic Stress Disorder
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Alcohol Drinking; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      In this project, investigators aim to test the hypothesis that CBD will reduce alcohol
      drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research
      focus because it shows promise for treating anxiety and other brain disorders, but does not
      produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is
      safe, with few or no side effects. AUD, which is one of the most common and most debilitating
      psychiatric conditions, is often associated with other comorbid psychiatric disorders - in
      particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also
      have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and
      clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies
      craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further,
      evidence shows that the brain circuits underlying negative emotion and addiction are linked
      in a forebrain area called the extended amygdala, which provides a neuropharmacological
      target to simultaneously treat both negative emotion and alcohol addiction in individuals
      with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading
      to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol
      seeking in animal models.
    

Intervention name(s): Cannabidiol; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg daily; This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that 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.
Other intervention name(s): CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cannabidiol