SUBLOCADE Rapid Initiation Study

Inclusion Criteria:

• Signed the informed consent form (ICF) and have the ability to comply with therequirements and restrictions listed therein.

• Documented history of moderate or severe opioid use disorder (OUD) as defined byDiagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

• Seeking buprenorphine-assisted treatment for OUD and is an appropriate candidate inthe opinion of the Investigator or medically qualified sub-Investigator.

• A female subject is eligible to participate if she is not pregnant (as confirmed bya negative urine human chorionic gonadotrophin test), is not lactating and, if ofchildbearing potential, agrees not to become pregnant while on the study and usemedically acceptable means of contraception while on the study.

Exclusion Criteria:

• Current diagnosis, other than OUD, requiring chronic opioid treatment.

• Meet DSM-5 criteria for severe alcohol-use disorder.

• Has received any medication assisted treatment within 2 weeks.

• Concurrent or prior treatment with any long-acting depot form of buprenorphinecontaining products.

• Concurrent treatment with another investigational agent or enrolment in anotherclinical study (except for an observational study) or treatment with anotherinvestigational agent within 30 days prior to screening.

• Concurrent treatment with medications contraindicated for use with buprenorphine asper local prescribing information, including benzodiazepines or any other centralnervous system depressants.

• Significant traumatic injury, major surgical procedure (as defined by theInvestigator) within 30 days prior to Day 1 or still recovering from prior surgery.

• Any other active medical condition, organ disease or concurrent medication ortreatment that may either compromise subject safety or interfere with studyendpoints.

• Congenital long QT syndrome, history of prolonged QT in the 3 months prior toscreening, or a corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470msec (female), or history of risk factors for Torsades de Pointes. Known personaland/or family history of congenital QT prolongation, or taking Class IAantiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or ClassIII antiarrhythmic medications (e.g., sotalol, amiodarone) or other mediations thatprolong the QT interval. Known family history of sudden unexplained death.

• Total bilirubin ≥1.5upper limit of normal (ULN), alanine aminotransferase (ALT) ≥3ULN, aspartate aminotransferase (AST) ≥5ULN, serum creatinine >2ULN atscreening.

• Abdominal area unsuitable for SC injections.

• Uncontrolled intercurrent illness including, but not limited to, a medical orpsychiatric illness/social situation that would limit compliance with studyrequirements or compromise the ability of the subject to provide written informedconsent.

• Known allergy or hypersensitivity to buprenorphine, ATRIGEL or their excipients.

• Subject to court order requiring treatment for OUD.

• Subjects who are unable, in the opinion of the Investigator or Indivior, to complyfully with the study requirements including those who are currently incarcerated orpending incarceration/legal action.

• Clinic staff and/or subjects who have a financial interest in the study or who havean immediate family member of either the clinic staff and/or Indivior employeesdirectly involved in the study.