ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Summary

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence.

The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

Conditions

• Opiate Dependence

Interventions

DRUG

VIVITROL® 380 mg

Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.

DRUG

Placebo

Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.

Sponsors & Collaborators

• Alkermes, Inc.

  lead INDUSTRY

Principal Investigators

• Evgeny Krupitsky, Prof. · Leningrad Regional Addiction Center

• Ruslan Ilyuk, Dr. · Bekhterev Psychoneurological Research Institute

• Edvin Zvartau, Prof. · Saint-Petersburg State Medical University n.a. Pavlov

• Alexander Sofronov, Prof. · Saint-Petersburg Addiction Hospital

• Alexey Egorov, Prof. · Saint-Petersburg Addiction Hospital

• Alexander Okhapkin, Prof. · Addiction Treatment Center, Clinical Facility of Smolensk State Medical Academy

• Nikolay Bokhan, Prof. · Tomsk Mental Health Research Institute

• Vladimir Mendelevich, Prof. · Kazan State Medical University

• Yuri Sivolap, Prof. · Moscow Medical Academy n.a. I.M. Sechenov

• Oleg Eryshev, Prof. · Bekhterev Psychoneurological Research Institute

• Nikolay Ivanets, Prof. · National Addiction Scientific Center

• Vitaliy Sinitskiy, Prof. · Northern State Medical University

• Andrey Anipchenko, Dr. · Saint-Petersburg Addiction Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2009-10-31

Completion

2010-11-30

Countries

• Russia

Study Locations