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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02740582
Other study ID # Tolcapone Lab Bar
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2016
Est. completion date November 1, 2019

Study information

Verified date September 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date November 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 40 Years
Eligibility 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.)

Study Design


Intervention

Drug:
Tolcapone

Placebo


Locations

Country Name City State
United States University of California, Berkeley Berkeley California
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Jennifer Mitchell

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Jul 2. doi: 10.1007/s00213 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. A laboratory bar session is 1 hour long
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