Medication Development in Alcoholism: Acamprosate Versus Naltrexone

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Alcoholism

Treatments: Drug: Placebo; Drug: Acamprosate; Drug: Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00656630

AA012602

R01AA012602 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 relative to placebo in early abstinence.

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Acamprosate

Treatment:

Drug: Acamprosate

2

Active Comparator group

Description:

Naltrexone

Treatment:

Drug: Naltrexone

3

Placebo Comparator group

Treatment:

Drug: Placebo