Conditions: Alcoholism
Keywords: Alcohol dependence
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

Brief summary:
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Detailed description:
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Medisorb naltrexone 380 mg intervention 2: Medisorb naltrexone 190 mg
Intervention descriptions: intervention 1: Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years. intervention 2: Administered via IM injection once every 4 weeks for up to 3.5 years.

Protocol document: