Phase 3
Completed N=378
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
Source: ClinicalTrials.gov NCT02537574 ↗Enrolled (actual)
378
Serious AEs
1.3%
Results posted
Jan 2019
Primary outcomePrimary: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection — 57; 51; 57 Participants — p=0.940
◆ Published Evidence
Established
48citations · ~6 / year
Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.
Summary
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
Linked Publications (2)
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Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: A phase 3 randomized trial.
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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 |
57; 51; 57 | 0.940 |
| SECONDARY Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection |
5.0; 4.5; 5.4 | — |
| SECONDARY Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection |
7.39; 7.78; 6.11 | — |
| SECONDARY Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection |
955.7; 1004.8; 800.6 | — |
| SECONDARY Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection |
48.1; 52.0; 45.8 | — |
| SECONDARY Incidence of Adverse Effects |
44; 31; 48 | — |
| SECONDARY Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection |
9038.5; 10,262.5; 9160.3 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent
- Willing and able to provide government-issued identification
- Has a BMI of 18.0-40.0 kg/m^2
- Has a physiologic dependence on opioids
- Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
- Wiling 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 used Buprenorphine within 7 days prior to randomization
- Has used Methadone within 14 days prior to randomization
- Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
- Has a history of seizures or has received anticonvulsant therapy within the past 5 years
- 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, or Naloxone
- Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
- Has significant suicidal ideation or behavior within the past year
- Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
- Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
- Is court mandated to receive treatment for opioid use disorder
- Additional criteria may apply
Data sourced from ClinicalTrials.gov (NCT02537574) 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.