- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613608
Alcohol Use Disorder and Cannabidiol
Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, we 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, 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 12 weeks. The current study will 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Raeghan Mueller, PhD
- Phone Number: 3037242210
- Email: raeghan.mueller@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Anschutz
-
Contact:
- Raeghan Mueller, PhD
- Email: raeghan.mueller@cuanschutz.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be ≥21 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- Expresses desire to reduce or quit drinking.
- If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening.
- Able to attend in-person visits at the study site.
- Participants reporting current nicotine use in any form will be included.
Exclusion Criteria:
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
- Daily cannabis use.
- Uses CBD products for medical reasons.
- Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), eating disorders, or any other psychotic mental disorder.
- Endorsing item 2 on the C-SSRS measure of suicide risk.
Currently taking any of the following medications:
- Those known to have a major interaction with Epidiolex.
- Acute treatment with any antiepileptic medications.
- Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
- Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
- Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.
- Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
- Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Lack of a stable living situation.
- Lack of access to internet.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Full-Spectrum Cannabidiol
210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
|
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.
|
Active Comparator: Broad-Spectrum Cannabidiol
210mg/day of full-spectrum cannabidiol, containing 0.0% THC.
|
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 Comparator: Placebo
210mg/day of hemp seed oil with no cannabinoids present.
|
Placebo arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Drinks per Drinking Day
Time Frame: 0-12 weeks
|
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.
|
0-12 weeks
|
Change in Alcohol Dependence/Craving
Time Frame: 0-12 weeks
|
The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems.
HDD and alcohol dependence/craving are the primary behavioral outcomes that will be analyzed.
|
0-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cue-reactivity
Time Frame: 0-12 weeks
|
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
|
0-12 weeks
|
Change in Anxiety
Time Frame: 0-12 weeks
|
The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension/stress.
Participants rate their anxiety on a scale from 1 (Did not apply to me at all) to 4 (Applied to me very much/most of the time), with higher scores indicating worse outcomes.
|
0-12 weeks
|
Change in Pain Levels
Time Frame: 0-12 weeks
|
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a consists of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain you can think of).
Participants are also asked to rate the impact of their pain in the last 7 days.
The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities.
|
0-12 weeks
|
Change in Sleep Disturbance
Time Frame: 0-12 weeks
|
The PROMIS Short Form v.1.0
- Sleep Disturbance - 4a will be used to measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days.
This includes perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction.
|
0-12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kent Hutchison, PhD, University of Colorado - Anschutz Medical Campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-1894
- R01AA029606 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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