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

August 30, 2007
August 30, 2007
September 2000
Not Provided
Percent Days Abstinent [ Time Frame: 18 months ]
Same as current
No Changes Posted
Percent Heavy Drinking Days [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
 
Research on Individualized Treatment for Alcoholism
Posttreatment Effects of Naltrexone

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
July 2005
Not Provided

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523133
R01AA12696-01A1
Yes
Not Provided
Indiana University School of Medicine
  • VA Boston Healthcare System
  • Brown University
  • George Washington University
Principal Investigator: Dena Davidson, PhD Indiana University School of Medicine
Indiana University
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP