Skip to main content
OpenTrials
Completed

NCT Number: NCT00523133

Research on Individualized Treatment for Alcoholism

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Psychiatry Outpatient Clinic

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percent Days Abstinent

    Time frame: 18 months

Secondary outcomes

  1. Percent Heavy Drinking Days

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Brown University
  • George Washington University
  • VA Boston Healthcare System

Registry information

Official study title

Posttreatment Effects of Naltrexone

Acronym: RITA

Important dates

Study start
2000
Study completion
2005
First posted
Aug 31, 2007
Registry last updated
Aug 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.