A Phase 3 interventional study of VIVITROL® 380 mg and Placebo in Opiate Dependence, sponsored by Alkermes, Inc.. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Alkermes, Inc. · Phase 3, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 250 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Alkermes, Inc. is the lead sponsor of 82 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Drug: VIVITROL® 380 mg
Drug: Placebo
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
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.
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.
Time frame: 20 weeks
Days to Discontinuation During Part A
Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.
Time frame: 168 days (24 weeks)
Craving Score: Change From Baseline
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").
Time frame: Baseline to 6 months (24 weeks)
Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)
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.
Time frame: 24 Weeks
Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24
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.
Time frame: 24 Weeks
| Milestone | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Started | 126 | 124 |
| Completed | 67 | 47 |
| Not completed | 59 | 77 |
| Milestone | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Started | 114 | 0 |
| Completed | 71 | 0 |
| Not completed | 43 | 0 |
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.
| Percentage of opioid-free weeks | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) | 90.0 ± 40.1 | 35.0 ± 43.3 |
Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.
| Days to study discontinuation | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Days to Discontinuation During Part A | NA (NA to NA) | 96.0 (63.0 to 165.0) |
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").
| Units on a scale | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Craving Score: Change From Baseline | -10.087 (-12.333 to -7.840) | 0.654 (-3.139 to 4.446) |
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.
| Percentage of participants who relapsed | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A) | 46.8 | 62.1 |
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.
| Percentage of opioid-free days | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24 | 75.83 (32.14 to 100.00) | 46.43 (11.01 to 96.76) |
Collected over 6 Months (Part A). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VIVITROL® 380 mg | — | 3/126 (2.4%) | 63/126 (50%) |
| Placebo | — | 4/124 (3.2%) | 40/124 (32.3%) |
| Event | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Acute sinusitisInfections and infestations | 0/126 | 1/124 |
| Lobar pneumoniaInfections and infestations | 0/126 | 1/124 |
| Drug dependencePsychiatric disorders | 0/126 | 1/124 |
| Psychotic disorderPsychiatric disorders | 0/126 | 1/124 |
| Peptic ulcerGastrointestinal disorders | 0/126 | 1/124 |
| Acquired immunodeficiency syndromeInfections and infestations | 1/126 | 0/124 |
| AdnexitisInfections and infestations | 1/126 | 0/124 |
| HIV infection WHO clinical stage IIIInfections and infestations | 1/126 | 0/124 |
| Herpes virus infectionInfections and infestations | 1/126 | 0/124 |
| Event | VIVITROL® 380 mg | Placebo |
|---|---|---|
| Alanine aminotransferase increasedInvestigations | 16/126 | 7/124 |
| Aspartate aminotransferase increasedInvestigations | 13/126 | 3/124 |
| Gamma-glutamyl transferase increasedInvestigations | 9/126 | 4/124 |
| NasopharyngitisInfections and infestations | 9/126 | 3/124 |
| InsomniaPsychiatric disorders | 8/126 | 1/124 |
| InfluenzaInfections and infestations | 6/126 | 5/124 |
| Injection site painGeneral disorders | 6/126 | 1/124 |
| HypertensionGastrointestinal disorders | 6/126 | 4/124 |
| ToothacheGastrointestinal disorders | 5/126 | 2/124 |
| HeadacheNervous system disorders | 4/126 | 3/124 |
| Age, Categorical(Participants) | VIVITROL® 380 mg | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 126 | 124 | 250 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | VIVITROL® 380 mg | Placebo | Total |
|---|---|---|---|
| Mean | 29.4 ± 4.8 | 29.7 ± 3.6 | 29.6 ± 4.2 |
| Gender(Participants) | VIVITROL® 380 mg | Placebo | Total |
|---|---|---|---|
| Female | 13 | 17 | 30 |
| Male | 113 | 107 | 220 |
| Region of Enrollment(participants) | VIVITROL® 380 mg | Placebo | Total |
|---|---|---|---|
| Russian Federation | 126 | 124 | 250 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Alkermes, Inc.