Actively Recruiting

Phase 2
Phase 3
Age: 21Years +
All Genders
NCT05613608

Alcohol Use Disorder and Cannabidiol

Led by University of Colorado, Denver · Updated on 2024-10-01

180

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

CONDITIONS

Official Title

Alcohol Use Disorder and Cannabidiol

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be 21 years old or older
  • Meets DSM-V criteria for moderate or severe Alcohol Use Disorder with at least 4 symptoms
  • Expresses a desire to reduce or quit drinking
  • Males must drink at least 15 standard alcoholic drinks per week; females must drink at least 10 drinks per week prior to screening
  • Able to attend in-person visits at the study site
  • Current nicotine users are eligible
Not Eligible

You will not qualify if you...

  • Diagnosis of any other substance use disorder
  • Use of illicit or recreational drugs such as cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days
  • Daily cannabis use
  • Use of CBD products for medical reasons
  • Serious psychiatric disorders including panic disorder, obsessive/compulsive disorder, PTSD, bipolar disorder, schizophrenia, cluster B personality disorders, eating disorders, or other psychotic disorders
  • Positive suicide risk item on the C-SSRS
  • Current use of medications that interact with Epidiolex, antiepileptics, or medications affecting alcohol intake (disulfiram, naltrexone, acamprosate, topiramate)
  • History of severe alcohol withdrawal like seizures or delirium tremens
  • Significant medical problems in the past six months affecting cardiovascular, renal, gastrointestinal, or endocrine systems
  • Current or past alcohol-related medical illness such as gastrointestinal bleeding, pancreatitis, liver disease, or peptic ulcer
  • Females who are pregnant, nursing, or not using reliable birth control
  • Current charges pending for violent crimes except DUI
  • Lack of stable living situation
  • Lack of internet access

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

R

Raeghan Mueller, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Alcohol Use Disorder and Cannabidiol | DecenTrialz