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Cannabinoid

Cannabidiol for Alcohol Use Disorder

Phase 2 & 3
Recruiting
Led By Kent Hutchison, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 weeks

Summary

This trial is testing if CBD can help reduce drinking in people with alcohol use disorder. Subjects will get one of 3 treatments for 12 wks.

Who is the study for?
This trial is for adults over 21 with moderate to severe Alcohol Use Disorder who drink heavily and want to cut down or stop. They must be able to visit the study site, not use cannabis daily, have no serious psychiatric disorders or recent medical issues, and not take certain medications that affect alcohol intake.
What is being tested?
The study tests full spectrum CBD and broad spectrum CBD against a placebo in reducing alcohol consumption over 12 weeks. Participants are randomly assigned one of these options without knowing which one they receive (double-blind).
What are the potential side effects?
While specific side effects aren't listed here, CBD can sometimes cause tiredness, diarrhea, changes in appetite/weight. Since this is research, there may be unknown risks or side effects involved.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Alcohol Craving
Change in Alcohol Use Disorder
Change in Drinks per Drinking Day
Secondary study objectives
Anxiety
Change in Cue-reactivity
Change in Impaired Control Scale (ICS)
+2 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Full-Spectrum CannabidiolActive Control1 Intervention
210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
Group II: Broad-Spectrum CannabidiolActive Control1 Intervention
210mg/day of full-spectrum cannabidiol, containing 0.0% THC.
Group III: PlaceboPlacebo Group1 Intervention
210mg/day of hemp seed oil with no cannabinoids present.

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
836 Previous Clinical Trials
1,082,750 Total Patients Enrolled
457 Trials studying Alcoholism
823,766 Patients Enrolled for Alcoholism
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,226 Total Patients Enrolled
12 Trials studying Alcoholism
1,536 Patients Enrolled for Alcoholism
Kent Hutchison, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
2 Previous Clinical Trials
541 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05613608 — Phase 2 & 3
Alcoholism Research Study Groups: Full-Spectrum Cannabidiol, Placebo, Broad-Spectrum Cannabidiol
Alcoholism Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05613608 — Phase 2 & 3
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05613608 — Phase 2 & 3
~107 spots leftby Apr 2027
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