Conditions: Alcoholism
Keywords: Alcoholism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 624
Healthy volunteers: no

Brief summary:
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.

Detailed description:
All subjects received standardized biopsychosocial support therapy (BRENDA Approach \[Volpicelli, JR \[2001\]; Guilford Press: New York\]) at each visit.

Subjects who completed this study (ie, received 6 injections of study drug and completed all study visits) and continued to meet eligibility criteria were given the option to enroll in extension study ALK21-003EXT (NCT01218971). A second extension, Study ALK21-010 (NCT00156923), was conducted subsequent to ALK21-003EXT.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Medisorb naltrexone 190 mg intervention 2: Medisorb naltrexone 380 mg intervention 3: Placebo matching Medisorb naltrexone 190 mg intervention 4: Placebo matching Medisorb naltrexone 380 mg
Intervention descriptions: intervention 1: Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations. intervention 2: IM injection once every 4 weeks for a total of 6 administrations. intervention 3: IM injection once every 4 weeks for a total of 6 administrations. intervention 4: IM injection once every 4 weeks for a total of 6 administrations.

Protocol document: