Clinical trial NCT03904849: Cannabidiol for Alcohol Use Disorder
Official title: A Pilot Human Laboratory Study of Cannabidiol in Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Average alcohol-induced sedation after medication ingestion
timeFrame: 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.
measure: Average subjective response to alcohol after medication ingestion
timeFrame: 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:
measure: Alcohol drinking in natural environment
timeFrame: 8 days of medication ingestion.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Joseph P Schacht, PhD
role: PRINCIPAL_INVESTIGATOR
References: