ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
NCT ID: NCT00678418
Last Updated: 2017-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2008-06-30
2010-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VIVITROL® 380 mg
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.
Placebo
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Evgeny Krupitsky, Prof.
Role: PRINCIPAL_INVESTIGATOR
Leningrad Regional Addiction Center
Ruslan Ilyuk, Dr.
Role: PRINCIPAL_INVESTIGATOR
Bekhterev Psychoneurological Research Institute
Edvin Zvartau, Prof.
Role: PRINCIPAL_INVESTIGATOR
Saint-Petersburg State Medical University n.a. Pavlov
Alexander Sofronov, Prof.
Role: PRINCIPAL_INVESTIGATOR
Saint-Petersburg Addiction Hospital
Alexey Egorov, Prof.
Role: PRINCIPAL_INVESTIGATOR
Saint-Petersburg Addiction Hospital
Alexander Okhapkin, Prof.
Role: PRINCIPAL_INVESTIGATOR
Addiction Treatment Center, Clinical Facility of Smolensk State Medical Academy
Nikolay Bokhan, Prof.
Role: PRINCIPAL_INVESTIGATOR
Tomsk Mental Health Research Institute
Vladimir Mendelevich, Prof.
Role: PRINCIPAL_INVESTIGATOR
Kazan State Medical University
Yuri Sivolap, Prof.
Role: PRINCIPAL_INVESTIGATOR
Moscow Medical Academy n.a. I.M. Sechenov
Oleg Eryshev, Prof.
Role: PRINCIPAL_INVESTIGATOR
Bekhterev Psychoneurological Research Institute
Nikolay Ivanets, Prof.
Role: PRINCIPAL_INVESTIGATOR
National Addiction Scientific Center
Vitaliy Sinitskiy, Prof.
Role: PRINCIPAL_INVESTIGATOR
Northern State Medical University
Andrey Anipchenko, Dr.
Role: PRINCIPAL_INVESTIGATOR
Saint-Petersburg Addiction Hospital
Locations
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Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation
Moscow, , Russia
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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ALK21-013
Identifier Type: -
Identifier Source: org_study_id
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