Research on Individualized Treatment for Alcoholism

Alcohol Dependence Clinical Trial

— RITA  

Official title:

Posttreatment Effects of Naltrexone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523133
• Other study ID #: R01AA012696-01A1
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2007
• Last updated: August 30, 2007
• Start date: September 2000
• Est. completion date: July 2005

Study information

• Verified date: August 2007
• Source: Indiana University
• 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 was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• men and women between the ages of 21-65

• current DSM-IV diagnosis of alcohol dependence

• abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation

• able to participate in an 18-month outpatient study

• live within a one hour or less commute to Fairbanks

• fluent in English

• women of child-bearing potential must have a negative pregnancy test and use effective contraceptive methods.

• score as contemplators or greater on the Readiness For Change Scale

Exclusion Criteria:

• severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)

• opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year

• pregnant or lactating females or those unwilling to use birth control

• inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions

• comorbid substance dependence (but not abuse) diagnosis in the past 6 months, excluding nicotine or marijuana dependence

• concomitant use of medications intended to decrease drinking (e.g. disulfiram)

• meeting current DSM criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• naltrexone
50 mg naltrexone daily for 3 months
• naltrexone
50 mg of naltrexone daily for 6 months

Behavioral:
• Broad Spectrum Treatment
8-14, one hour sessions over 6 months
• Motivational Enhancement Treatment
4, 20 minute sessions over 3 months

Locations

Country	Name	City	State
United States	University Hospital, Psychiatry Outpatient Clinic	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Brown University, George Washington University, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Days Abstinent		18 months
Secondary	Percent Heavy Drinking Days		18 months