ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
This study has been completed.
Sponsor:
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT00678418
First Posted: May 15, 2008
Last Update Posted: February 10, 2017
Information provided by (Responsible Party):
Alkermes, Inc.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Opiate Dependence | Drug: VIVITROL® 380 mg Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence |
Resource links provided by NLM:
Further study details as provided by Alkermes, Inc.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
- 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").
- 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.
- 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.
| Enrollment: | 250 |
| Study Start Date: | June 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
| 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.
|
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.
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678418
Locations
| Russian Federation | |
| Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation | |
| Moscow, Russian Federation, 109074 | |
Sponsors and Collaborators
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 |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alkermes, Inc. |
| ClinicalTrials.gov Identifier: | NCT00678418 History of Changes |
| Other Study ID Numbers: |
ALK21-013 |
| First Submitted: | May 14, 2008 |
| First Posted: | May 15, 2008 |
| Results First Submitted: | December 20, 2010 |
| Results First Posted: | January 21, 2011 |
| Last Update Posted: | February 10, 2017 |
| Last Verified: | December 2016 |
Keywords provided by Alkermes, Inc.:
|
Addiction Opiate dependence Inpatient detoxification opioid dependence heroin dependence |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Analgesics, Opioid Naltrexone Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |