Alcohol Use Disorder and Cannabidiol

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

Qualifiers

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, or if a male respondent reports consuming 5 or more alcoholic drinks on at least one drinking day per week on average (4 or more if female).

Disqualifiers

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.

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.

Trial design

Treatments tested in this trial

  • Cannabidiol
  • Placebo

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator