Research on Individualized Treatment for Alcoholism

Study Overview
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Brief Summary
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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.

Official Title
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Posttreatment Effects of Naltrexone

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: naltrexone
* Drug: naltrexone
* Behavioral: Broad Spectrum Treatment
* Behavioral: Motivational Enhancement Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Days Abstinent |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Heavy Drinking Days |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcoholism, naltrexone, motivational enhancement therapy