Conditions: Amphetamine Dependence
Keywords: amphetamine dependence amphetamine injection VIVITROL/VIVITROL placebo amphetamine craving
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.

Detailed description:

Arms:
arm 1: Efficacy of 24 week course of Extended Release VIVITROL 380 mg with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) arm 2: Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)

Interventions: intervention 1: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Intervention descriptions: intervention 1: Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)

Protocol document: