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)

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