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Behavioral Naltrexone Therapy for Heroin Dependence
NCT00332228Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2002
- Primary completion
- Dec 2007
- Countries
- 1
- Sponsor
- New York State Psychiatric Institute
- Modality
- Small Molecules
- Drugs
- naltrexone
- Conditions
- heroin dependence
01
Overview
Phase 2, randomised, double-blind trial of naltrexone in heroin dependence (4 arms), sponsored by New York State Psychiatric Institute. Primary endpoints: Proportion of patients relapsing to illicit opiates at 6 months and Proportion of patients retained in treatment at 6 months. Started Jun 2002; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
CE plus oral +depot naltrexone
Compliance enhancement (CE) + oral naltrexone + two depot naltrexone injections
CE plus oral naltrexone+ placebo
Compliance enhancement (CE) + oral naltrexone + two placebo injections
BNT plus Depot naltrexone
Behavioral Naltrexone Therapy (BNT) + oral naltrexone + two depot naltrexone injections
BNT plus PBO injection
Behavioral Naltrexone Therapy (BNT) + oral naltrexone + two placebo injections
03
Who it enrols
Adults aged 18-60 with current opiate dependence, willing to participate with a significant other, excluding those with severe medical/psychiatric illnesses, recent overdose, or current methadone/opiate use.
04
Endpoints
Primary
Proportion of patients relapsing to illicit opiates
Proportion of patients retained in treatment
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