Research on Individualized Treatment for Alcoholism (RITA)

This study has been completed.
Sponsor:
Collaborators:
VA Boston Healthcare System
Brown University
George Washington University
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00523133
First received: August 30, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Drug: naltrexone
Behavioral: Broad Spectrum Treatment
Behavioral: Motivational Enhancement Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Posttreatment Effects of Naltrexone

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Percent Days Abstinent [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Percent Heavy Drinking Days [ Time Frame: 18 months ]

Enrollment: 185
Study Start Date: September 2000
Study Completion Date: July 2005
Intervention Details:
    Drug: naltrexone
    50 mg naltrexone daily for 3 months
    Drug: naltrexone
    50 mg of naltrexone daily for 6 months
    Behavioral: Broad Spectrum Treatment
    8-14, one hour sessions over 6 months
    Behavioral: Motivational Enhancement Treatment
    4, 20 minute sessions over 3 months
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523133

Locations
United States, Indiana
University Hospital, Psychiatry Outpatient Clinic
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
VA Boston Healthcare System
Brown University
George Washington University
Investigators
Principal Investigator: Dena Davidson, PhD Indiana University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523133     History of Changes
Other Study ID Numbers: R01AA12696-01A1
Study First Received: August 30, 2007
Last Updated: August 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
alcoholism
naltrexone
motivational enhancement therapy

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014