Alcohol Use Disorder and Cannabidiol

NCT05613608 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 22-1894R01AA029606
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alcohol Use Disorder

Keywords

alcohol; cannabidiol; cbd; cannabis

Outcome Measures

Primary Outcomes (3)

• Change in 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.

  0-12 weeks

• Change in Alcohol Use Disorder

  The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems.

  0-12 weeks

• Change in Alcohol Craving

  The Penn Alcohol Craving Scale (PACS) will be used to assess changes in alcohol craving.

  0-12 Weeks

Secondary Outcomes (5)

• Change in Cue-reactivity

  0-12 weeks

• Change in Anxiety

  0-12 weeks

• Change in Pain Levels

  0-12 weeks

• Change in Sleep Disturbance

  0-12 weeks

• Change in Impaired Control Scale (ICS)

  0-12 Weeks

Study Arms (3)

Full-Spectrum Cannabidiol

ACTIVE COMPARATOR

210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

Drug: Cannabidiol

Broad-Spectrum Cannabidiol

ACTIVE COMPARATOR

210mg/day of full-spectrum cannabidiol, containing 0.0% THC.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

210mg/day of hemp seed oil with no cannabinoids present.

Drug: Placebo

Interventions

Cannabidiol DRUG

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.

Broad-Spectrum Cannabidiol; Full-Spectrum Cannabidiol

Placebo DRUG

Placebo arm.

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Color Vision Defects; Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Kent Hutchison, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raeghan Mueller, PhD

CONTACT

3037242210; raeghan.mueller@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blind, placebo-controlled, parallel group study.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 14, 2022
• Study Start: April 30, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will be submitted twice yearly with the first submission to occur in April 2023. The data will be available on the NIMH Data Archive indefinitely.

Locations

US (1)