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Research on Individualized Treatment for Alcoholism (RITA)

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
naltrexone
naltrexone
Broad Spectrum Treatment
Motivational Enhancement Treatment
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcoholism, naltrexone, motivational enhancement therapy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Psychiatry Outpatient Clinic

Outcomes

Primary Outcome Measures

Percent Days Abstinent

Secondary Outcome Measures

Percent Heavy Drinking Days

Full Information

First Posted
August 30, 2007
Last Updated
August 30, 2007
Sponsor
Indiana University School of Medicine
Collaborators
VA Boston Healthcare System, Brown University, George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT00523133
Brief Title
Research on Individualized Treatment for Alcoholism
Acronym
RITA
Official Title
Posttreatment Effects of Naltrexone
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine
Collaborators
VA Boston Healthcare System, Brown University, George Washington University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcoholism, naltrexone, motivational enhancement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone
Intervention Description
50 mg naltrexone daily for 3 months
Intervention Type
Drug
Intervention Name(s)
naltrexone
Intervention Description
50 mg of naltrexone daily for 6 months
Intervention Type
Behavioral
Intervention Name(s)
Broad Spectrum Treatment
Intervention Description
8-14, one hour sessions over 6 months
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Treatment
Intervention Description
4, 20 minute sessions over 3 months
Primary Outcome Measure Information:
Title
Percent Days Abstinent
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Percent Heavy Drinking Days
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dena Davidson, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Psychiatry Outpatient Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Research on Individualized Treatment for Alcoholism

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