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

December 21, 2016 updated by: Alkermes, Inc.

Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults.

Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year.

At the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years.

Dosing was performed by the principal investigator or designated study staff member.

All subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 109074
        • Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Primary Inclusion Criteria:

  • Written, informed consent
  • 18 years of age or older
  • Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria
  • Voluntarily seeking treatment for opioid dependence
  • Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days
  • Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone
  • Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures
  • Agree to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

  • Pregnancy or lactation
  • Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings)
  • Positive naloxone challenge test at randomization (Day 0)
  • Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
  • Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator disease in HIV-infected subjects
  • Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase(ALT) >3xULN
  • Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise ability to complete the study
  • Recent history (within 6 months prior to screening) of suicidal ideation or attempt
  • Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine
  • Active alcohol dependence within prior 6 months
  • Current alcohol use disorder that would, in the Investigator's opinion, preclude successful completion of the study
  • Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening
  • Use of oral naltrexone for 7 consecutive days within 60 days prior to screening
  • Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
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.
EXPERIMENTAL: VIVITROL® 380 mg
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.
Other Names:
  • Naltrexone for extended-release injectable suspension
  • Medisorb® naltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)
Time Frame: 20 weeks
Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days to Discontinuation During Part A
Time Frame: 168 days (24 weeks)
Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.
168 days (24 weeks)
Craving Score: Change From Baseline
Time Frame: Baseline to 6 months (24 weeks)
Measured using subjects' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 ("No craving") to 100 ("highest possible craving").
Baseline to 6 months (24 weeks)
Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)
Time Frame: 24 Weeks
Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.
24 Weeks
Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24
Time Frame: 24 Weeks
Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Principal Investigator: Evgeny Krupitsky, Prof., Leningrad Regional Addiction Center
  • Principal Investigator: Ruslan Ilyuk, Dr., Bekhterev Psychoneurological Research Institute
  • Principal Investigator: Edvin Zvartau, Prof., Saint-Petersburg State Medical University n.a. Pavlov
  • Principal Investigator: Alexander Sofronov, Prof., Saint-Petersburg Addiction Hospital
  • Principal Investigator: Alexey Egorov, Prof., Saint-Petersburg Addiction Hospital
  • Principal Investigator: Alexander Okhapkin, Prof., Addiction Treatment Center, Clinical Facility of Smolensk State Medical Academy
  • Principal Investigator: Nikolay Bokhan, Prof., Tomsk Mental Health Research Institute
  • Principal Investigator: Vladimir Mendelevich, Prof., Kazan State Medical University
  • Principal Investigator: Yuri Sivolap, Prof., Moscow Medical Academy n.a. I.M. Sechenov
  • Principal Investigator: Oleg Eryshev, Prof., Bekhterev Psychoneurological Research Institute
  • Principal Investigator: Nikolay Ivanets, Prof., National Addiction Scientific Center
  • Principal Investigator: Vitaliy Sinitskiy, Prof., Northern State Medical University
  • Principal Investigator: Andrey Anipchenko, Dr., Saint-Petersburg Addiction Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (ESTIMATE)

May 15, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2017

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK21-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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