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)
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: NTX/BUP; NTX/PBO-B; PBO-N/PBO-B
Intervention description: Daily doses; Daily doses; Daily doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Alkermes; Buprenorphine; Naltrexone; Vivitrol; Opioid Use; Opiates; Dependence; Abuse; Heroin; Painkillers; Substance Abuse

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.
    

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