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Trial record 1 of 1 for:    tolcapone lab bar
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Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users

This study is currently recruiting participants.
Verified January 2017 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT02740582
First Posted: April 15, 2016
Last Update Posted: January 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition Intervention
Alcohol Abuse Impulsive Behavior Drug: Tolcapone Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Tolcapone on Decision Making and Alcohol Intake Using a Laboratory Bar in Moderate to Heavy Social Drinkers

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Number of drinks consumed in a laboratory bar session [ Time Frame: A laboratory bar session is approximately 3 hours long ]
    Number of drinks consumed in a laboratory bar session following either placebo or tolcapone administration.


Estimated Enrollment: 80
Study Start Date: October 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolcapone
40 moderate to heavy social alcohol users will receive 6 days of 100 mg tolcapone TID with an additional 100 mg one time immediately prior to the laboratory bar testing.
Drug: Tolcapone
Other Name: Tasmar
Placebo Comparator: Placebo
40 moderate to heavy social alcohol users will receive 6 days of matched placebo TID with an additional placebo capsule immediately prior to the laboratory bar testing.
Drug: Placebo

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)
  Contacts and Locations
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): NCT02740582


Contacts
Contact: Jennifer Mitchell, PhD 510-985-3921 Jennifer.Mitchell@ucsf.edu
Contact: Allison Coker, PhD 510-394-5103 Allison.Coker@ucsf.edu

Locations
United States, California
University of California, Berkeley Recruiting
Berkeley, California, United States, 94704
Contact: Jennifer Mitchell, PhD    510-985-3921    Jennifer.Mitchell@ucsf.edu   
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94109
Contact: Jennifer Mitchell, PhD    510-985-3921    jennifer.mitchell@ucsf.edu   
Contact: Allison Coker, PhD    510-394-5103    allison.coker@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jennifer Mitchell, PhD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02740582     History of Changes
Other Study ID Numbers: Tolcapone Lab Bar
First Submitted: April 12, 2016
First Posted: April 15, 2016
Last Update Posted: January 16, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Tolcapone
Alcoholism
Alcohol Drinking
Impulsive Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action