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

Indivior

Status and phase: Completed; Phase 3

Conditions: Opioid Use Disorder; Opioid-related Disorders

Treatments: Drug: SUBOXONE sublingual film; Drug: RBP-6000

Study type: Interventional

Funder types: Industry

Identifiers

NCT02510014

RB-US-13-0003

Details and patient eligibility

About

A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.

Full description

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.

Enrollment: 775 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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775 participants in 2 patient groups

Roll-over Subjects

Experimental group

Description:

Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period.

Treatment:

Drug: RBP-6000

Drug: SUBOXONE sublingual film

De Novo Subjects

Experimental group

Description:

Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period.

Treatment:

Drug: RBP-6000

Drug: SUBOXONE sublingual film