Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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 relative to placebo in early abstinence.

Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Acamprosate

Group Type ACTIVE_COMPARATOR

Acamprosate

Intervention Type DRUG

Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration

2

Naltrexone

Group Type ACTIVE_COMPARATOR

Naltrexone

Intervention Type DRUG

50mg capsule, Once daily, 1 week duration

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo capsule, 1 week duration

Interventions

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Acamprosate

Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration

Intervention Type DRUG

Naltrexone

50mg capsule, Once daily, 1 week duration

Intervention Type DRUG

Placebo

Matched placebo capsule, 1 week duration

Intervention Type DRUG

Other Intervention Names

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Campral ReVia Sugar pill

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No