Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Naltrexone; Placebo; Buprenorphine
Intervention description: daily dosing; daily dosing; daily dosing
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: naltrexone; VIVITROL; buprenorphine; opioid; addiction

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.
    

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