Effects of Tolcapone on Decision Making and Alcohol Intake in Alcohol Users
Condition: Alcohol Abuse; Impulsive Behavior
MeSH terms: Alcoholism; Impulsive Behavior; Alcohol Drinking
Intervention: Tolcapone; Placebo
Intervention MeSH terms: Tolcapone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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.)