Alcohol Abuse Clinical Trial
Official title:
Effects of Tolcapone on Decision Making and Alcohol Intake Using a Laboratory Bar in Moderate to Heavy Social Drinkers
Verified date | September 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.) |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Berkeley | Berkeley | California |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Jennifer Mitchell |
United States,
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
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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