Medication Development in Alcoholism: Acamprosate Versus Naltrexone - Full Text View

Sponsors and Collaborators:	The Scripps Research Institute National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00656630

Purpose

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.

Condition	Intervention
Alcoholism	Drug: Acamprosate Drug: Naltrexone Drug: Placebo

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Acamprosate Acamprosate calcium Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone

Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:

Urge to Drink [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Affective State [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physiological Reactivity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Drinking [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Mood [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Sleep [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Craving [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Acamprosate	Drug: Acamprosate Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
2: Active Comparator Naltrexone	Drug: Naltrexone 50mg capsule, Once daily, 1 week duration
3: Placebo Comparator	Drug: Placebo Matched placebo capsule, 1 week duration

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 relative to placebo in early abstinence.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females ≥ 18 and ≤ 55 years of age
Meets DSM-IV criteria for current alcohol dependence
Does not desire treatment
Alcohol free, as verified by breath alcohol concentration, with a 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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656630

Contacts

Contact: Marni Jacobs, MPH	858-784-7465	mjacobs@scripps.edu
Contact: Susan Quello	858-784-7327	squello@scripps.edu

Locations

United States, California
The Scripps Research Institute	Recruiting
La Jolla, California, United States, 92037
Contact: Marni Jacobs 858-784-7465
Principal Investigator: Barbara J. Mason, PhD

Sponsors and Collaborators

The Scripps Research Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	The Scripps Research Institute - Pearson Center for Alcoholism and Addiction Research ( Barbara J. Mason, PhD )
Study ID Numbers:	AA012602
Study First Received:	April 4, 2008
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00656630
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol
Acamprosate

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Alcohol Deterrents

ClinicalTrials.gov processed this record on January 16, 2009