ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) 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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence|
- Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]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.
- Days to Discontinuation During Part A [ Time Frame: 168 days (24 weeks) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|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.
|Placebo Comparator: 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.
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.
|Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation|
|Moscow, Russian Federation, 109074|
|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|