CBD for the Treatment of Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, placebo-controlled, parallel group study designed to assess the
      efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to
      reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If
      eligible for the study, subjects will be randomized to receive one of the conditions for 8
      weeks.
    

Detailed description: 
      The current study will directly test the hypothesis that a moderate dose of CBD leads to a
      reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and
      anxiety. It is further hypothesized that CBD will lead to increased sleep duration and
      quality among individuals with AUD who want to quit or reduce their drinking. The study will
      also determine whether the small amount of THC found in full spectrum hemp-derived CBD
      products produces any negative effects. The hypotheses are grounded in previous studies
      suggesting that CBD reduces the reinforcing properties of alcohol and decreases drinking
      motivation and consumption (Viudez-Martínez, García-Gutiérrez, Fraguas-Sánchez, et al.,
      2018). Further, CBD has shown clinical promise for tobacco, cannabis, and opioid use
      disorders (Hurd, 2017; Hurd et al., 2015; Prud'homme et al., 2015), and evidence indicates
      that these effects may be due to the ability of CBD to reduce cue-induced craving and anxiety
      (Gonzalez-Cuevas et al., 2018; Hurd et al., 2019). The hypotheses are also grounded in the
      pre-clinical literature suggesting that CBD may modulate the immune system and have
      anti-inflammatory effects which also helps to reduce harm associated with alcohol and may
      have a positive effect on those attempting to quit. Other potential mechanisms that might
      underlie the effects of CBD include a reduction in the severity of acute withdrawal, a
      reduction in protracted withdrawal, and the neuroprotective effects of CBD. Given the
      background literature with respect to CBD and AUDs, a logical next step is for human studies
      to address these questions.

      To better understand the effects of hemp-derived CBD with and without a small amount of THC,
      the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety,
      tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC)
      vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population
      of AUD subjects.

      This is a double-blind, placebo-controlled, parallel group study designed to assess the
      efficacy of fsCBD and bsCBD, compared to a placebo control (PC), to reduce drinking in
      participants with moderate alcohol use disorder according to the DSM-V. If eligible for the
      study, subjects will be randomized to receive one of the conditions for 8 weeks.

      To minimize risk of COVID transmission, the investigators will utilize Zoom for weekly
      subject check-ins and our Mobile Pharmacology Lab (MPL) for the collection of blood samples
      and clinical data for the majority of in-person visits. The initial Week 0 / Baseline visit
      will take place at the University of Colorado Anschutz Medical Campus. There will be MPL
      follow-up visits at Weeks 1, 4, and 8. Participants will be contacted by Zoom each remaining
      week during the 8-week period. A follow up Zoom interview will occur in Week 16 approximately
      8 weeks after the end of dosing.

      Overall, the clinical study is expected to take 1-2 years to complete enrollment and data
      analysis.
    

Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.; Placebo arm
Other intervention name(s): CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, placebo-controlled, parallel group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol; Cannabidiol; CBD; Cannabis