Medication Development in Alcoholism: Acamprosate Versus Naltrexone

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Scripps Research Institute
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Acamprosate; Naltrexone

Criteria

Inclusion Criteria:

• Males or females ≥ 18 and ≤ 55 years of age

• Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence

• Does not desire treatment

• Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (CIWA) ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session

• Able to complete and understand questionnaires and study procedures in English

• Verbal I.Q. estimate ≥ 85

• Signed informed consent

Exclusion Criteria:

• Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine

• Significant medical disorders that will increase potential risk or interfere with study participation

• Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control

• Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders

• Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents

• Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use

• Liver function tests more than three times normal or elevated bilirubin

• No fixed domicile and/or no availability by telephone or beeper

• Current involvement in or plans for treatment prior to study completion

• Patients who have a history of adverse drug reactions to the study drugs or their ingredients

• Failure to take double-blind medication as prescribed

• Inability to understand or comply with the provisions of the protocol or consent form