Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2000-09-30
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Interventions
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naltrexone
50 mg naltrexone daily for 3 months
naltrexone
50 mg of naltrexone daily for 6 months
Broad Spectrum Treatment
8-14, one hour sessions over 6 months
Motivational Enhancement Treatment
4, 20 minute sessions over 3 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
65 Years
ALL
No
Sponsors
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VA Boston Healthcare System
FED
Brown University
OTHER
George Washington University
OTHER
Indiana University School of Medicine
OTHER
Principal Investigators
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Dena Davidson, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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University Hospital, Psychiatry Outpatient Clinic
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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