Cannabidiol for Alcohol Use Disorder

A Pilot Human Laboratory Study of Cannabidiol in Alcohol Use Disorder

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

Study Overview

• Status: Withdrawn
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Cannabidiol

Detailed Description

This study will examine the effects of Epidiolex among adults who drink alcohol heavily but who are not seeking treatment for their alcohol use. Epidiolex is an FDA-approved formulation of cannabidiol, the primary non-psychoactive constituent of cannabis. Participants in the study will be randomly assigned to take Epidiolex or placebo for 8 days. There are 3 study visits, including a day-long visit in the laboratory.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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).
2. 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.
3. Currently not engaged in, and does not want treatment for, alcohol-related problems.
4. Age 21-40.
5. Able to read and understand questionnaires and informed consent.
6. Lives within 50 miles of the study site.

Exclusion Criteria:

1. Current DSM-5 diagnosis of any other substance use disorder except Nicotine Use Disorder.
2. Any psychoactive substance use (including cannabis, but excluding nicotine) within 30 days prior to screening, as indicated by self-report and urine drug screen.
3. Any cannabidiol use, in any formulation (e.g., oral, topical) within 30 days prior to screening.
4. 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.
5. Current active suicidal ideation, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
6. 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).
7. Current use of any known hepatotoxic medication.
8. Current use of strong or moderate CYP3A4 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include protease inhibitors, macrolide antibiotics [e.g., erythromycin], azole antifungals [e.g., ketoconazole], verapamil, and grapefruit juice).
9. Current use of strong or moderate CYP2C19 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include proton pump inhibitors [e.g., omeprazole, lansoprazole], prednisone, and norethisterone).
10. 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).
11. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
12. Past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, or peptic ulcer.
13. 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.
14. Females of childbearing potential who are pregnant (by serum HCG), nursing, or who are not using a reliable form of birth control.
15. Current charges pending for a violent crime (not including driving under the influence-related offenses).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cannabidiol; Cannabidiol 6 mL of 100 mg/mL cannabidiol oral solution per day for 8 days	Drug: Cannabidiol; Cannabidiol oral solution; Other Names: Epidiolex
Placebo Comparator: Placebo; Placebo 6 mL oral solution per day for 8 days	Drug: Placebo; Placebo oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol drinking in natural environment	Total number of standard drinks per day consumed during natural (usual environment) conditions	8 days of medication ingestion.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Joseph P Schacht, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 00086168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No