Cannabidiol for Alcohol Use Disorder

NCT03904849 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 00086168
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether cannabidiol, relative to placebo, affects subjective response to alcohol or alcohol drinking.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Average alcohol-induced sedation after medication ingestion

  Biphasic Alcohol Effects Scale sedation subscale score (range = 0-70; higher scores = greater sedation)

  Average of measurements obtained 30, 60, 90, and 120 minutes following alcohol administration in the lab. Alcohol will be administered 2.5 hours after ingestion of study medication.

• Average subjective response to alcohol after medication ingestion

  Subjective High Assessment Scale score (range = 0-130; higher scores = greater intoxication)

  Average of measurements obtained 30, 60, 90, and 120 minutes following alcohol administration in the lab. Alcohol will be administered 2.5 hours after ingestion of study medication.

Secondary Outcomes (1)

• Alcohol drinking in natural environment

  8 days of medication ingestion.

Study Arms (2)

Cannabidiol

ACTIVE COMPARATOR

Cannabidiol 6 mL of 100 mg/mL cannabidiol oral solution per day for 8 days

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Placebo 6 mL oral solution per day for 8 days

Drug: Placebo

Interventions

Cannabidiol DRUG

Cannabidiol oral solution

Also known as: Epidiolex

Cannabidiol

Placebo DRUG

Placebo oral solution

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for current Alcohol Use Disorder, as assessed by the Structured Clinical Interview for DSM-5 (SCID-5).
• Reports drinking, on average, at least 20 standard alcoholic drinks per week for at least the past 3 months, with at least 5 standard alcoholic drinks during a drinking episode at least once per week during the past 3 months.
• Currently not engaged in, and does not want treatment for, alcohol-related problems.
• Age 21-40.
• Able to read and understand questionnaires and informed consent.
• Lives within 50 miles of the study site.

You may not qualify if:

• Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
• Any psychoactive substance use (including cannabis, but excluding nicotine) within 30 days prior to screening, as indicated by self-report and urine drug screen.
• Any cannabidiol use, in any formulation (e.g., oral, topical) within 30 days prior to screening.
• Current DSM-5 Axis I diagnosis, including major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.
• Current active suicidal ideation, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Current use of any psychoactive medication, any medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate), and/or antiepileptic medications (e.g., valproate).
• Current use of any known hepatotoxic medication.
• History of severe alcohol withdrawal (e.g., seizure, delirium tremens), as evidenced by self-report and assessment with Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar).
• Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
• Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
• Current or past hepatocellular disease, as indicated by: a) verbal report; b) Child-Pugh score \> 6 (i.e., Child-Pugh class B or C); or c) alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater than the upper limit of the normal range at screening.
• Females of childbearing potential who are pregnant (by serum HCG), nursing, or who are not using a reliable form of birth control.
• Current charges pending for a violent crime (not including driving under the influence-related offenses).

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Joseph P Schacht, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 5, 2019
• Study Start: October 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)