Research on Individualized Treatment for Alcoholism

NCT00523133 | Completed Phase 2 DMC

• 1 other identifier: R01AA012696-01A1
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Dependence

Keywords

alcoholism; naltrexone; motivational enhancement therapy

Outcome Measures

Primary Outcomes (1)

• Percent Days Abstinent

  18 months

Secondary Outcomes (1)

• Percent Heavy Drinking Days

  18 months

Interventions

naltrexone DRUG

50 mg naltrexone daily for 3 months

Broad Spectrum Treatment BEHAVIORAL

8-14, one hour sessions over 6 months

Motivational Enhancement Treatment BEHAVIORAL

4, 20 minute sessions over 3 months

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• VA Boston Healthcare System: collaborator
• Brown University: collaborator
• George Washington University: collaborator

Study Sites (1)

University Hospital, Psychiatry Outpatient Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Dena Davidson, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: September 1, 2000
• Study Completion: July 1, 2005
• Last Updated: August 31, 2007

Record last verified: 2007-08

Locations

US (1)