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

Sponsor:	The Scripps Research Institute
Collaborator:	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. This study involves two laboratory sessions and an fMRI scan.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Acamprosate calcium Acamprosate

U.S. FDA Resources

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 ]
fMRI Scan [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
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
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
Claustrophobic (MRI is small environment)
Non removable metal, e.g., braces (metals are dangerous for MRI)
Is in need of or currently taking psychoactive medication (could alter cerebral blood flow characteristics)
Inability to understand or comply with the provisions of the protocol or consent form
History of neurological disorder, e.g., seizures, meningitis, migraine, HIV, head trauma with loss of consciousness > 2 minutes, or learning disability
Left-handed (lateralization interpretations on fMRI are complicated with left-handed subjects

Contacts and Locations

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

Locations

United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037

Sponsors and Collaborators

The Scripps Research Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Barbara J Mason, Ph.D.

The Scripps Research Institute

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The Scripps Research Institute - Pearson Center for Alcoholism and Addiction Research ( Barbara J. Mason, PhD )
Study ID Numbers:	AA012602, R01AA012602
Study First Received:	April 4, 2008
Last Updated:	January 8, 2010
ClinicalTrials.gov Identifier:	NCT00656630 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Acamprosate
Mental Disorders
Sensory System Agents
Therapeutic Uses

Alcoholism
Naltrexone
Substance-Related Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Alcohol Deterrents

ClinicalTrials.gov processed this record on February 08, 2010