Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID

NCT00656630

Run by

The Scripps Research Institute

People needed

68

Starts

2007-12-01

Expected to finish

2010-01-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Scripps Research Institute — La Jolla, California, United States

Full record on ClinicalTrials.gov

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