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

NCT00678418 | Completed Phase 3 Results

• 1 other identifier: ALK21-013
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Addiction; Opiate dependence; Inpatient detoxification; opioid dependence; heroin dependence

Outcome Measures

Primary Outcomes (1)

• Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)

  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 Outcomes (4)

• Days to Discontinuation During Part A

  168 days (24 weeks)

• Craving Score: Change From Baseline

  Baseline to 6 months (24 weeks)

• Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)

  24 Weeks

• Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24

  24 Weeks

Study Arms (2)

VIVITROL® 380 mg

EXPERIMENTAL

Drug: VIVITROL® 380 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

VIVITROL® 380 mg DRUG

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.

Also known as: Naltrexone for extended-release injectable suspension, Medisorb® naltrexone

VIVITROL® 380 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written, informed consent
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation

Moscow, 109074, Russia

Location

Related Publications (6)

• Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: long-term safety and effectiveness. Addiction. 2013 Sep;108(9):1628-37. doi: 10.1111/add.12208. Epub 2013 May 24.

  PMID: 23701526 RESULT

• Nunes EV, Krupitsky E, Ling W, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Treating Opioid Dependence With Injectable Extended-Release Naltrexone (XR-NTX): Who Will Respond? J Addict Med. 2015 May-Jun;9(3):238-43. doi: 10.1097/ADM.0000000000000125.

  PMID: 25901451 RESULT

• Mitchell MC, Memisoglu A, Silverman BL. Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. J Stud Alcohol Drugs. 2012 Nov;73(6):991-7. doi: 10.15288/jsad.2012.73.991.

  PMID: 23036218 RESULT

• Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

  PMID: 40342086 DERIVED

• Krupitsky E, Zvartau E, Blokhina E, Verbitskaya E, Wahlgren V, Tsoy-Podosenin M, Bushara N, Burakov A, Masalov D, Romanova T, Tyurina A, Palatkin V, Slavina T, Pecoraro A, Woody GE. Randomized trial of long-acting sustained-release naltrexone implant vs oral naltrexone or placebo for preventing relapse to opioid dependence. Arch Gen Psychiatry. 2012 Sep;69(9):973-81. doi: 10.1001/archgenpsychiatry.2012.1a.

  PMID: 22945623 DERIVED

• Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011 Apr 30;377(9776):1506-13. doi: 10.1016/S0140-6736(11)60358-9.

  PMID: 21529928 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive; Heroin Dependence

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Bernard L. Silverman, MD
• Organization: Alkermes, Inc.

bernard.silverman@alkermes.com

1-781-609-6000

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 15, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2010
• Last Updated: February 10, 2017
• Results First Posted: January 21, 2011

Record last verified: 2016-12

Locations

RU (1)