Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Intervention: Parafon Forte
Intervention description: Drug: Parafon Forte administered at study visit
Other: Placebo administered at study visit
Intervention MeSH terms: Chlorzoxazone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The overall goals of this study are to (1) expand knowledge about interactions of
      chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in
      moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on
      visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria: Healthy adults who are social drinkers 21 - 50 years of age.

          1. Moderate to heavy social drinkers (women=10-25 drinks/week, men=14-30 drinks/week).

          2. If female, must be non-lactating, not pregnant, and using a reliable contraception
             method (i.e. abstinence, intrauterine device [IUD], or hormonal birth control).

          3. Able and willing to provide written informed consent.

          4. Able to understand and follow the instructions of the investigator, and understand all
             rating scales.

        Exclusion Criteria:

          1. Use of cocaine, amphetamines, hallucinogens, "ecstasy", opiates, sedatives, pain
             pills, sleeping pills, or other psychoactive drugs more than twice a week.

          2. A history of complicated alcohol or other drug withdrawal syndrome(s), e.g. delirium
             tremens or seizures.

          3. Current physiological dependence on any psychoactive drug (except nicotine or
             caffeine) including alcohol, as determined by MD or NP assessment.

          4. Current enrollment in an alcohol or other drug treatment program, or current legal
             problems relating to alcohol or other drug use, including awaiting trial or
             supervision by a parole or probation officer.

          5. Currently trying to quit using alcohol and/or "recreational" drugs.

          6. Clinically significant medical or psychiatric illness as determined by screening blood
             tests, medical history, and physical exam performed or reviewed by the study MD or NP.

          7. Bilirubin more than 2 times the normal upper limit.

          8. AST (SGOT), ALT (SGPT), or alkaline phosphatase more than 2 ½ times the normal upper
             limit.

          9. Symptoms of liver disease, as assessed by MD or NP assessment (jaundice, Hx of
             hepatitis, itchy skin, etc.).

         10. A current pregnancy, or a woman of child-bearing potential not currently using an
             adequate means of contraception.

         11. BAC level greater than 0.05% at the beginning of Screening Visit, Visit 1 or Visit 4.

         12. Neurological dysfunction or psychiatric disorder severe enough to interfere with
             assessment of outcome measures as defined above.

         13. Known allergy to chlorzoxazone.

         14. Has received an investigational drug within 30 days prior to Study Visit 2 (after
             screening visit).

         15. Subjects who are unable to read or speak English.

         16. Those who, in the opinion of the investigator, are considered unable to adhere to
             scheduled appointments, are unlikely to comply with the study protocol, or who are
             unsuitable for any other reason.