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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-01-31

Brief Summary

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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®).

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Detailed Description

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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.

Conditions

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Alcoholism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medisorb naltrexone 380 mg

Group Type EXPERIMENTAL

Medisorb naltrexone 380 mg

Intervention Type DRUG

Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.

Medisorb naltrexone 190 mg

Group Type EXPERIMENTAL

Medisorb naltrexone 190 mg

Intervention Type DRUG

Administered via IM injection once every 4 weeks for up to 3.5 years.

Interventions

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Medisorb naltrexone 380 mg

Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.

Intervention Type DRUG

Medisorb naltrexone 190 mg

Administered via IM injection once every 4 weeks for up to 3.5 years.

Intervention Type DRUG

Other Intervention Names

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VIVITROL® 380 mg Naltrexone for extended-release injectable suspension Naltrexone for extended-release injectable suspension

Eligibility Criteria

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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