Research on Individualized Treatment for Alcoholism
Phase 2
Completed
- Conditions
- Alcohol Dependence
- Registration Number
- NCT00523133
- Lead Sponsor
- Indiana University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Percent Days Abstinent 18 months
- Secondary Outcome Measures
Name Time Method Percent Heavy Drinking Days 18 months
Trial Locations
- Locations (1)
University Hospital, Psychiatry Outpatient Clinic
🇺🇸Indianapolis, Indiana, United States