Overview

This trial is active, not recruiting.

Conditions opioid use disorder, opioid-related disorders
Treatments suboxone sublingual film, high dose rbp-6000, low dose rbp-6000
Phase phase 3
Sponsor Indivior Inc.
Start date July 2015
End date February 2017
Trial size 672 participants
Trial identifier NCT02510014, RB-US-13-0003

Summary

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 monthly injections of open-label high dose RBP-6000. RBP-6000 dose can be adjusted to low dose, 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subjects who have completed RB-US-13-0001 will have the option to enroll in this study and receive up to 6 months treatment with open label RBP-6000. Subjects will initially receive SUBOXONE sublingual film run-in followed by monthly injections of high dose RBP-6000. Dose can be adjusted to low dose RBP-6000 based on judgement of the Investigator.
suboxone sublingual film SUBOXONE
Suboxone sublingual film used for induction therapy. Participants to take sublingual film for 4-14 days at doses from 8mg-24mg
high dose rbp-6000 RBP-6000
Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose can be adjusted to low dose based on the medical judgment of the Investigator
low dose rbp-6000 RBP-6000
Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose can be adjusted to high dose based on the medical judgment of the Investigator
(Experimental)
Subjects who did not participate in RB-US-13-0001 will receive up to 12 months treatment with open label RBP-6000. After screening, all subjects will receive SUBOXONE sublingual film run in followed by monthly injections of high dose RBP-6000. Dose can be adjusted to low dose RBP-6000 based on the judgement of the Investigator.
suboxone sublingual film SUBOXONE
Suboxone sublingual film used for induction therapy. Participants to take sublingual film for 4-14 days at doses from 8mg-24mg
high dose rbp-6000 RBP-6000
Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose can be adjusted to low dose based on the medical judgment of the Investigator
low dose rbp-6000 RBP-6000
Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose can be adjusted to high dose based on the medical judgment of the Investigator

Primary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: 1-12 months
Number of participants with adverse events as a measure of safety and tolerability
time frame: 1-12 months

Secondary Outcomes

Measure
To collect continued use of opioids and other drugs through urine drug screening in subjects receiving RBP-6000 injections
time frame: 6-12- months
To collect self-reports of continued use of opioids and other drugs and alcohol through timeline followback interview (TLFB)
time frame: 6-12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title An Open-Label, Long-Term Safety and Tolerability Study of Depot Buprenorphine (RBP-6000) in Treatment-Seeking Subjects With Opioid Use Disorder
Description Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately 300 subjects who completed the randomized,double-blind, placebo-controlled study, RB-US-13-0001, and approximately 300 subjects who did not participate in study RB-US-13-0001. Following informed consent and completion of screening procedures, all subjects will receive SUBOXONE sublingual film, titrated to response. After 4-14 days of SUBOXONE film treatment, subjects will be evaluated for enrollment into the study.Eligible subjects will receive high dose RBP-6000 as an initial dose, followed by monthly injections of low or high dose RBP-6000, based on the medical judgment of the investigator. Subjects who participated in study RB-US-13-0001 will receive monthly injections for up to 6 months. Subjects who did not participate in study RB-US-13-0001 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Indivior Inc..