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)

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