A Phase 2 interventional study of Cannabidiol and Placebo in Alcohol Use Disorder, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum cannabidiol (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.
The current study will directly test the hypothesis that a moderate dose of cannabidiol (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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 45 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Currently taking any of the following medications:
150mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.
Drug: Cannabidiol
150mg/day of broad-spectrum cannabidiol, containing 0%THC.
Drug: Cannabidiol
150mg/day of hemp-seed oil with no cannabinoids present.
Drug: Placebo
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.
Also known as: CBD
Placebo arm
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Time frame: 0-8 weeks
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Time frame: 0-16 weeks
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Time frame: 0-4 weeks
Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Time frame: 4-8 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Time frame: 0-16 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Time frame: 4-8 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Time frame: 0-8 weeks
Alcohol Dependence/Craving
The Alcohol Dependence Scale measures the severity of alcohol dependence. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependence. The Penn Alcohol Craving Scale (PACS) measures alcohol craving. Possible scores range from 0 to 30, where higher scores indicate greater craving.
Time frame: 0-4 weeks
Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
Time frame: 0-4 weeks
Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
Time frame: 4-8 weeks
Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006) .
Time frame: 0-8 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Time frame: 0-4 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Time frame: 4-8 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Time frame: 0-8 weeks
Anxiety
The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire designed to measure three related negative emotional states and yields three subscale scores for depression, anxiety and tension/stress. Possible scores on the anxiety subscale range from 0 to 21, with higher scores indicating more severe symptoms of anxiety.
Time frame: 0-16 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Time frame: 0-4 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Time frame: 4-8 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Time frame: 0-8 weeks
Subjective Pain Level
The Adult PROMIS Numerical Rating Scale v1.0 Pain Intensity 1a measures the severity of subjective pain. Possible scores range from 0 to 10, with higher scores indicating more severe symptoms of subjective pain.
Time frame: 0-16 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Time frame: 0-16 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Time frame: 0-8 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Time frame: 4-8 weeks
Sleep Quality
The Adult PROMIS Short Form v1.0 Sleep Disturbance 4a measures the severity of sleep disturbances. Possible scores range from 4 to 20, with higher scores indicating more severe symptoms of sleep disturbance.
Time frame: 0-4 weeks
Plan to share: No
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University of Colorado, Denver