Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately
300 subjects who completed the randomized,double-blind, placebo-controlled study NCT02357901
(RB-US-13-0001) ('roll-over' participants), and approximately 300 subjects who did not
participate in study RB-US-13-0001 ('de novo' participants). Following informed consent and
completion of screening procedures, all subjects will receive SUBOXONE sublingual film,
titrated to response.

After 4-14 days of SUBOXONE sublingual film treatment, subjects will be evaluated for
enrollment into the study. Eligible subjects will receive 300 mg RBP-6000 as an initial dose,
followed by monthly injections of 100 mg or 300 mg RBP-6000, based on the medical judgment of
the investigator.

Subjects who participated in study RB-US-13-0001 ('roll-over' participants) will receive
monthly injections for up to 6 months. Subjects who did not participate in study
RB-US-13-0001 ('de novo' participants) will receive monthly injections for up to12 months.

At all injection visits continuous electrocardiogram recordings and pulse oximetry will be
collected prior to injection and at least 4 hours after injection. Subjects will return to
the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event
and injection site assessments.

Inclusion Criteria:

De novo subjects:

- Seeking treatment for opioid use disorder (OUD) and for the previous 3 months meet the
Diagnostic and Statistical Manual 5 (DSM-5) criteria for moderate or severe OUD

- Appropriate candidate for opioid partial-agonist treatment

- BMI between 18 and 35, inclusive

Roll-over subjects:

- Completed RB-US-13-0001

Exclusion Criteria:

De novo subjects:

- Current diagnosis, other than OUD, requiring chronic opioid treatment

- Current substance use disorder with regard to substances other than opioids, cocaine,
cannabis, tobacco or alcohol

- Received medication-assisted treatment for OUD in the 90 days prior to informed
consent

- Use (within past 30 days prior to informed consent) or positive urine drug screen
(UDS) at screening for barbiturates, benzodiazepines,methadone or buprenorphine

- Treatment for OUD required by court order

- History of recent suicidal ideation or attempt

Roll over subjects:

- Experienced major protocol deviations or adverse events in RB-US-13-0001 which could
potentially compromise subject safety

- Discontinued early from study RB-US-13-0001