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

NCT ID: NCT02510014

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 775 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-27
• Study Completion Date: 2017-01-31

Brief 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 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.

Detailed 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.

Conditions

Opioid Use Disorder; Opioid-related Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roll-over Subjects

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.

Group Type: EXPERIMENTAL

SUBOXONE sublingual film

Intervention Type: DRUG

SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.

RBP-6000

Intervention Type: DRUG

Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.

De Novo Subjects

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.

Group Type: EXPERIMENTAL

SUBOXONE sublingual film

Intervention Type: DRUG

SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.

RBP-6000

Intervention Type: DRUG

Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.

Interventions

SUBOXONE sublingual film

SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.

Intervention Type: DRUG

RBP-6000

Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.

Intervention Type: DRUG

Other Intervention Names

SUBOXONE; buprenorphine; Atrigel buprenorphine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indivior Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Director Clinical Development

Role: STUDY_DIRECTOR

Indivior Inc.

Locations

Haleyville Clinical Research

Haleyville, Alabama, United States

Boyett Health Services

Hamilton, Alabama, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Collaborative Neuroscience Network

Garden Grove, California, United States

Behavioral Research Specialists

Glendale, California, United States

Synergy Clinical Research Center

National City, California, United States

Pacific Research Partners

Oakland, California, United States

North County Clinical Research

Oceanside, California, United States

Neuropsychiatric Research Center of Orange County

Orange, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Amit Vijapura

Jacksonville, Florida, United States

Sarkis Clinical Trials

Lake City, Florida, United States

Meridien Research

Lakeland, Florida, United States

Innovative Clinical Research

Lauderhill, Florida, United States

Florida Clinical Research Center

Maitland, Florida, United States

Try Research

Maitland, Florida, United States

Scientific Clinical Research

North Miami, Florida, United States

Research Centers of America

Oakland Park, Florida, United States

Atlanta Institute of Medicine and Research

Alpharetta, Georgia, United States

Phoenix Medical Research

Prairie Village, Kansas, United States

Louisiana Research Associates

New Orleans, Louisiana, United States

Louisiana Clinical Research

Shreveport, Louisiana, United States

Stanley Street Treatment and Resources

Fall River, Massachusetts, United States

Adams Clinical Trials

Watertown, Massachusetts, United States

Precise Research Centers, Inc.

Flowood, Mississippi, United States

St Louis Clinical Trials

St Louis, Missouri, United States

Altea Research

Las Vegas, Nevada, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

The Medical Research Network, LLC

New York, New York, United States

Neuro-behavioral Clinical Research

Canton, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Charak Clinical Research Center

Garfield Heights, Ohio, United States

Oklahoma Clinical Research Center

Oklahoma City, Oklahoma, United States

Pahl Pharmaceutical Professionals

Oklahoma City, Oklahoma, United States

CODA

Portland, Oregon, United States

Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA

Altoona, Pennsylvania, United States

UPenn Treatment Research Center

Philadelphia, Pennsylvania, United States

Carolina Clinical Trials

Charleston, South Carolina, United States

Pillar Clinical Research

Dallas, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

Aspen Clinical Research, LLC

Orem, Utah, United States

Countries

United States

References

Rutrick D, Learned SM, Boyett B, Hassman D, Shinde S, Zhao Y. 18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. J Subst Use Addict Treat. 2023 Nov;154:209155. doi: 10.1016/j.josat.2023.209155. Epub 2023 Aug 30.

Reference Type: DERIVED

PMID: 37657559 (View on PubMed)

Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.

Reference Type: DERIVED

PMID: 35287034 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Original

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Document Type: Study Protocol: Amendment 1

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Document Type: Study Protocol: Amendment 2

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Document Type: Study Protocol: Amendment 3

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Document Type: Statistical Analysis Plan

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Document Type: Study Protocol: Amendment 4

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Other Identifiers

RB-US-13-0003

Identifier Type: -

Identifier Source: org_study_id