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

Primary Purpose

Alcohol Abuse, Impulsive Behavior

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tolcapone

Placebo

About this trial

This is an interventional basic science trial for Alcohol Abuse

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

University of California, Berkeley
University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tolcapone First, then Placebo

Placebo First, then Tolcapone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Drinks Consumed in a Laboratory Bar Session

Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.

Secondary Outcome Measures

Full Information

NCT ID

NCT02740582

First Posted

April 12, 2016

Last Updated

September 17, 2020

Sponsor

Jennifer Mitchell

1. Study Identification

Unique Protocol Identification Number

NCT02740582

Brief Title

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

Official Title

Effects of Tolcapone on Decision Making and Alcohol Intake Using a Laboratory Bar in Moderate to Heavy Social Drinkers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2016 (Actual)

Primary Completion Date

September 1, 2019 (Actual)

Study Completion Date

November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jennifer Mitchell

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Abuse, Impulsive Behavior

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tolcapone First, then Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo First, then Tolcapone

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tolcapone

Other Intervention Name(s)

Tasmar

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of Drinks Consumed in a Laboratory Bar Session

Description

Number of drinks consumed in a laboratory bar session (out of a maximum of 4 drinks available) following either placebo or tolcapone administration.

Time Frame

A laboratory bar session is 1 hour long

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Mitchell, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Berkeley

City

Berkeley

State/Province

California

ZIP/Postal Code

94704

Country

United States

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32617646

Citation

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.

Results Reference

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

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