Status:
COMPLETED
Medication Development in Alcoholism: Acamprosate Versus Naltrexone
Lead Sponsor:
The Scripps Research Institute
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00656630
Start Date
December 1 2007
End Date
January 1 2010
Last Update
March 29 2017
Active Locations (1)
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1
The Scripps Research Institute
La Jolla, California, United States, 92037