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Research on Individualized Treatment for Alcoholism (RITA)

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ClinicalTrials.gov Identifier: NCT00523133
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : August 31, 2007
Sponsor:
Collaborators:
VA Boston Healthcare System
Brown University
George Washington University
Information provided by:
Indiana University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: naltrexone Behavioral: Broad Spectrum Treatment Behavioral: Motivational Enhancement Treatment Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Posttreatment Effects of Naltrexone
Study Start Date : September 2000
Actual Study Completion Date : July 2005

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Arms and Interventions
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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

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

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

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523133


Locations
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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
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Principal Investigator: Dena Davidson, PhD Indiana University School of Medicine
More Information
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ClinicalTrials.gov Identifier: NCT00523133     History of Changes
Other Study ID Numbers: R01AA012696-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: August 31, 2007
Last Verified: August 2007
Keywords provided by Indiana University:
alcoholism
naltrexone
motivational enhancement therapy
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
 Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents