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Post-Treatment Effects of Naltrexone
NCT00006449Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2000
- Countries
- 1
- Sponsor
- Indiana University
- Modality
- Small Molecules
- Drugs
- naltrexone
- Conditions
- alcohol dependence
01
Overview
Phase 4, randomised, double-blind trial of naltrexone in alcohol dependence (4 arms), sponsored by Indiana University. Primary endpoint: Percent days abstinent at 18 months. Started Sep 2000; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
3-Month Naltrexone + BST
Naltrexone for 3 months with Broad Spectrum Treatment
3-Month Naltrexone + MET
Naltrexone for 3 months with Motivational Enhancement Therapy
6-Month Naltrexone + BST
Naltrexone for 6 months with Broad Spectrum Treatment
6-Month Naltrexone + MET
Naltrexone for 6 months with Motivational Enhancement Therapy
03
Who it enrols
Adults with current alcohol dependence, abstinent for 3-21 days, fluent in English, and living within 1 hour of the facility. Excludes severe liver disease, recent opiate use, comorbid substance dependence (except nicotine/marijuana), and severe psychiatric disorders.
04
Endpoints
Primary
Percent days abstinent
Secondary
Percent heavy drinking days
Relapse to heavy drinking
Alcohol Craving
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