Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Alcoholism Clinical Trial

Official title:

Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656630
• Other study ID #: AA012602
• Secondary ID: R01AA012602
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2008
• Last updated: December 7, 2016
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2016
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. This study involves two laboratory sessions and an fMRI scan.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Acamprosate
Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
• Naltrexone
50mg capsule, Once daily, 1 week duration
• Placebo
Matched placebo capsule, 1 week duration

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urge to Drink		1 week	No
Secondary	Physiological Reactivity		1 week	No
Secondary	Drinking		1 week	No
Secondary	Mood		1 week	No
Secondary	Sleep		1 week	No
Secondary	Craving		1 week	No

External Links

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