Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users

NCT ID: NCT02740582

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2019-11-01

Brief Summary

The purpose of this study is to determine the effects of tolcapone on decision making and alcohol intake using a laboratory bar (on-site alcohol self-administration) in alcohol drinkers.

Detailed Description

The study is a 7-session, double blind, placebo-controlled crossover study of the effects of tolcapone, the COMT inhibitor, on decision making and alcohol intake using a laboratory bar in moderate to heavy social alcohol drinkers. Subjects will be moderate to heavy social users of alcohol, defined as at least 10 standard drinks per week for women and at least 14 standard drinks per week for men. There will be one screening session followed by six additional visits including 2 laboratory bar sessions. On each study drug administration day, subjects will come in to the clinic for a medication dispensation visit and instructions on when and how to take the study drug for the remainder of the study. Study drug bottles will be equipped with MEMS caps to ensure compliance. After 5 days of drug administration, subjects will return to the clinic for a laboratory bar. This session will consist of administration of a standardized laboratory bar paradigm and a series of computerized and written decision-making tasks. Subjects will then be crossed over and complete the same series of study visits on the alternate study drug.

Conditions

Alcohol Abuse; Impulsive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Tolcapone First, then Placebo

Tolcapone arm first: 5 days of 100 mg tolcapone TID, followed by washout period, then 5 days of placebo TID

Group Type: EXPERIMENTAL

Tolcapone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo First, then Tolcapone

Placebo arm first: 5 days placebo, followed by washout period, followed by 5 days of 100 mg tolcapone TID

Group Type: PLACEBO_COMPARATOR

Tolcapone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Tolcapone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Tasmar

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers who are 21-40 years of age
• If female, 10 or more alcoholic drinks must be consumed weekly.
• If male, 14 or more alcoholic drinks must be consumed weekly.
• Meets DSM-V criteria for Alcohol Use Disorder (AUD).
• If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
• Ability to read and speak English.
• High school graduate.
• Able and willing to provide an informed consent.
• Able to understand and follow the instructions of the investigator, including the delayed discounting tasks. Residing within 5 miles of the study site.

Exclusion Criteria

• Positive urine drug screen (except marijuana).
• Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills. or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
• Marijuana use more than 3 times/week.
• Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
• Currently trying to quit alcohol use.
• History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
• Two SGPT/ALT or SGOT/AST values greater than the upper limit of normal.
• Unable to pass the Standard Field Sobriety Test in a sober state (BAC = 0.00).
• BAC level >0.05% at the beginning of screening visit (within margin of error of detection).
• Regular use of any of the drugs on the tolcapone contraindications list OR within 2 weeks of drug administration.
• Severe low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100). Allergy or intolerance to tolcapone.
• Subject has received an investigational drug within 30 days of the screening visit.
• Subject is considered unsuitable for the study in the opinion of the investigator or clinician for any other reason (such as an Axis II personality disorder that makes the subject unable to comply with study instructions, per the Clinician's judgement.)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jennifer Mitchell

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mitchell

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, Berkeley

Berkeley, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

Coker AR, Weinstein DN, Vega TA, Miller CS, Kayser AS, Mitchell JM. The catechol-O-methyltransferase inhibitor tolcapone modulates alcohol consumption and impulsive choice in alcohol use disorder. Psychopharmacology (Berl). 2020 Oct;237(10):3139-3148. doi: 10.1007/s00213-020-05599-5. Epub 2020 Jul 2.

Reference Type: RESULT

PMID: 32617646 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Tolcapone Lab Bar

Identifier Type: -

Identifier Source: org_study_id