SUBLOCADE Rapid Initiation Study
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Intervention: TM buprenorphine; SUBLOCADE
Intervention description: 4mg TM buprenorphine, investigator choice as to brand; 300mg subcutaneous injection
Intervention MeSH terms: Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment
      following a shorter period of transmucosal (TM) buprenorphine treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed the informed consent form (ICF) and have the ability to comply with the
             requirements and restrictions listed therein.

          -  Documented history of moderate or severe opioid use disorder (OUD) as defined by
             Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

          -  Seeking buprenorphine-assisted treatment for OUD and is an appropriate candidate in
             the opinion of the Investigator or medically qualified sub-Investigator.

          -  A female subject is eligible to participate if she is not pregnant (as confirmed by a
             negative urine human chorionic gonadotrophin test), is not lactating and, if of
             childbearing potential, agrees not to become pregnant while on the study and use
             medically 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 buprenorphine
             containing products.

          -  Concurrent treatment with another investigational agent or enrolment in another
             clinical study (except for an observational study) or treatment with another
             investigational agent within 30 days prior to screening.

          -  Concurrent treatment with medications contraindicated for use with buprenorphine as
             per local prescribing information, including benzodiazepines or any other central
             nervous system depressants.

          -  Significant traumatic injury, major surgical procedure (as defined by the
             Investigator) within 30 days prior to Day 1 or still recovering from prior surgery.

          -  Any other active medical condition, organ disease or concurrent medication or
             treatment that may either compromise subject safety or interfere with study endpoints.

          -  Congenital long QT syndrome, history of prolonged QT in the 3 months prior to
             screening, or a corrected QT interval (Fridericia's - QTcF) >450 msec (male) or >470
             msec (female), or history of risk factors for Torsades de Pointes. Known personal
             and/or family history of congenital QT prolongation, or taking Class IA antiarrhythmic
             medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic
             medications (e.g., sotalol, amiodarone) or other mediations that prolong the QT
             interval. Known family history of sudden unexplained death.

          -  Total bilirubin ≥1.5*upper limit of normal (ULN), alanine aminotransferase (ALT)
             ≥3*ULN, aspartate aminotransferase (AST) ≥5*ULN, serum creatinine >2*ULN at screening.

          -  Abdominal area unsuitable for SC injections.

          -  Uncontrolled intercurrent illness including, but not limited to, a medical or
             psychiatric illness/social situation that would limit compliance with study
             requirements or compromise the ability of the subject to provide written informed
             consent.

          -  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 comply
             fully with the study requirements including those who are currently incarcerated or
             pending incarceration/legal action.

          -  Clinic staff and/or subjects who have a financial interest in the study or who have an
             immediate family member of either the clinic staff and/or Indivior employees directly
             involved in the study.