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ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

NCT01218997 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2011-01-04

Study results available
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Summary

This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.

Conditions

  • Alcoholism

Interventions

DRUG

Medisorb naltrexone 380 mg

Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.

DRUG

Oral naltrexone 50 mg

Tablet taken orally once daily for up to 1 year

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard L. Silverman, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2005-03-31
Completion
2005-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218997 on ClinicalTrials.gov