ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

Alkermes

Status and phase: Completed; Phase 3

Conditions: Alcoholism

Treatments: Drug: Medisorb naltrexone 190 mg; Drug: Medisorb naltrexone 380 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00156923

ALK21-010

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria:

• Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections
• Willing and able to return for scheduled clinic visits and study assessments
• Noncustodial, stable address and phone
• Written, informed consent

Primary Exclusion Criteria:

• Pregnancy or lactation
• Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Medisorb naltrexone 380 mg

Experimental group

Treatment:

Drug: Medisorb naltrexone 380 mg

Medisorb naltrexone 190 mg

Experimental group

Treatment:

Drug: Medisorb naltrexone 190 mg