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ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

NCT01218958 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2017-07-11

Study results available
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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.

Conditions

  • Alcoholism

Interventions

DRUG

Medisorb naltrexone 190 mg

Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.

DRUG

Medisorb naltrexone 380 mg

IM injection once every 4 weeks for a total of 6 administrations.

DRUG

Placebo matching Medisorb naltrexone 190 mg

IM injection once every 4 weeks for a total of 6 administrations.

DRUG

Placebo matching Medisorb naltrexone 380 mg

IM injection once every 4 weeks for a total of 6 administrations.

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard Silverman, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2003-09-30
Completion
2003-09-30

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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 NCT01218958 on ClinicalTrials.gov