Phase 3
Completed N=101
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Source: ClinicalTrials.gov NCT02696434 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Feb 2019
Primary outcomePrimary: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 — 35; 38 Participants — p=0.407
◆ Published Evidence
Emerging
8citations · ~1 / year
Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.
Summary
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of VIVITROL.
Linked Publications (3)
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Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.
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Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended-release naltrexone in a residential setting.
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Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 |
35; 38 | 0.407 |
| SECONDARY Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection |
5.8; 6.3 | — |
| SECONDARY Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal |
2.4; 2.6 | — |
| SECONDARY Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7) |
6.0; 5.0 | — |
| SECONDARY Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period |
4.5; 3.9 | — |
| SECONDARY Mean Score for "Desire for Opioids" Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period |
6.3; 8.3 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
38; 37 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent
- Willing and able to provide government-issued identification
- Has a Body Mass Index (BMI) of 18.0-40.0 kg/m^2
- Has a history of opioid use disorder diagnosis for at least 6 months
- Has a history of prescribed buprenorphine (or buprenorphine/naloxone) maintenance for the prior 3 or more consecutive months and is currently buprenorphine-maintained
- Must be voluntarily seeking treatment for opioid use disorder and be motivated to receive antagonist therapy
- Willing to abide by the contraception requirements for the duration of the study
- Additional criteria may apply
Exclusion Criteria
- Is pregnant, planning to become pregnant or breastfeeding during the study
- Has a positive urine drug screen for opiates or oxycodone at screening
- Has used methadone within 30 days prior to study Day -5
- Has used naltrexone (oral or VIVITROL) within the 90 days prior to Day -5
- Has a history of seizures or has received anticonvulsant therapy within the past 5 years for treatment of seizures (use of anticonvulsant during the past detoxification is not exclusionary)
- Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
- Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
- Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
- Has a history of hypersensitivity or adverse reaction to buprenorphine, naltrexone, VIVITROL, or naloxone
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT02696434) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.