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

NCT02740582 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: Tolcapone Lab Bar
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Abuse; Impulsive Behavior

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tolcapone First, then Placebo

EXPERIMENTAL

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

Drug: Tolcapone; Drug: Placebo

Placebo First, then Tolcapone

PLACEBO COMPARATOR

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

Drug: Tolcapone; Drug: Placebo

Interventions

Tolcapone DRUG

Also known as: Tasmar

Placebo First, then Tolcapone; Tolcapone First, then Placebo

Placebo DRUG

Placebo First, then Tolcapone; Tolcapone First, then Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Jennifer Mitchell: lead

Study Sites (2)

University of California, Berkeley

Berkeley, California, 94704, United States

Location

University of California, San Francisco

San Francisco, California, 94109, United States

Location

Related 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 Oct;237(10):3139-3148. doi: 10.1007/s00213-020-05599-5. Epub 2020 Jul 2.

  PMID: 32617646 RESULT

MeSH Terms

Conditions

Alcoholism; Impulsive Behavior

Interventions

Tolcapone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitrophenols; Phenols; Ketones; Nitro Compounds

Results Point of Contact

• Title: Jennifer Mitchell, PhD
• Organization: University of California, San Franciso

jennifer.mitchell@ucsf.edu

510-985-3522

Study Officials

• Jennifer Mitchell, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-09

Locations

US (2)