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Trial record 2 of 204 for:    epidiolex

Cannabidiol for Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03904849
Recruitment Status : Not yet recruiting
First Posted : April 5, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Cannabidiol Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Human Laboratory Study of Cannabidiol in Alcohol Use Disorder
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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 Name: Epidiolex

Placebo Comparator: Placebo
Placebo 6 mL oral solution per day for 8 days
Drug: Placebo
Placebo oral solution




Primary Outcome Measures :
  1. Average alcohol-induced sedation after medication ingestion [ Time Frame: 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. ]
    Biphasic Alcohol Effects Scale sedation subscale score (range = 0-70; higher scores = greater sedation)

  2. Average subjective response to alcohol after medication ingestion [ Time Frame: 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. ]
    Subjective High Assessment Scale score (range = 0-130; higher scores = greater intoxication)


Secondary Outcome Measures :
  1. Alcohol drinking in natural environment [ Time Frame: 8 days of medication ingestion. ]
    Total number of standard drinks per day consumed during natural (usual environment) conditions



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904849


Contacts
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Contact: Joseph P Schacht, PhD (843) 792-7497 schacht@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Joseph P Schacht, PhD    843-792-7497    schacht@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Joseph P Schacht, PhD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03904849     History of Changes
Other Study ID Numbers: 00086168
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Epidiolex
Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pharmaceutical Solutions
Anticonvulsants