Open-Label Treatment Extension Study

NCT02896296 | Completed Phase 3 Results FDA Drug

• 1 other identifier: INDV-6000-301
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 29

Brief Summary

Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.

Conditions

Opioid Use Disorder; Opioid-related Disorders

Outcome Measures

Primary Outcomes (3)

• Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period

  TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition.

  Day 1 up to Week 29

• Percentage Change From Baseline to Week 25 in Vital Signs

  Vital signs include: * systolic blood pressure (mmHg) * diastolic blood pressure (mmHg) * respiratory rate (breaths/minute) * pulse oximetry (%) * pulse rate (beats/min) * temperature (C)

  Day 1, Week 25

• Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values

  TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. The number of participants with TEAEs specific to laboratory tests are summarized.

  Day 1 up to Week 25

Study Arms (1)

RBP-6000 (100/300 mg Flex)

EXPERIMENTAL

On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.

Drug: RBP-6000

Interventions

RBP-6000 DRUG

Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator.

Also known as: atrigel buprenorphine, extended-release buprenorphine

RBP-6000 (100/300 mg Flex)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written consent to participate in this study.
• Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).
• Be considered eligible in the medical judgment of the Investigator.
• Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent form (ICF)) must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 6 months after the last dose of investigational medicinal product (IMP).
• Males: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
• Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.
• Subjects must be willing to adhere to study procedures.

You may not qualify if:

• Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
• Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
• History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF.
• Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (29)

Boyett Health Services

Hamilton, Alabama, 35570, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

Pacific Research Partners

Oakland, California, 94612, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Amit Vijapura

Jacksonville, Florida, 32256, United States

Location

Meridien Research

Lakeland, Florida, 33805, United States

Location

Innovative Clinical Research

Lauderhill, Florida, 33319, United States

Location

Scientific Clinical Research

North Miami, Florida, 33161, United States

Location

Phoenix Medical Research

Prairie Village, Kansas, 66206, United States

Location

Louisiana Research Associates

New Orleans, Louisiana, 70114, United States

Location

Louisiana Clinical Research

Shreveport, Louisiana, 71101, United States

Location

Stanley Street Treatment and Resources

Fall River, Massachusetts, 02720, United States

Location

Adams Clinical Trials

Watertown, Massachusetts, 02472, United States

Location

Precise Research Centers, Inc.

Flowood, Mississippi, 39232, United States

Location

St Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Altea Research

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Neuro-behavioral Clinical Research

Canton, Ohio, 44708, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Rakesh Ranjan MD & Associates, Inc.

Garfield Heights, Ohio, 44125, United States

Location

Pahl Pharmaceutical Professionals

Oklahoma City, Oklahoma, 73112, United States

Location

SP Research, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

CODA

Portland, Oregon, 97232, United States

Location

Keystone Clinical Solutions

Altoona, Pennsylvania, 16601, United States

Location

Carolina Clinical Trials

Charleston, South Carolina, 29407, United States

Location

Pillar Clinical Research

Dallas, Texas, 75243, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Related Publications (2)

• 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.

  PMID: 37657559 DERIVED

• 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.

  PMID: 35287034 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Global Director, Clinical Development
• Organization: Indivior, Inc.

Robert.Bauer@Indivior.com

804-379-1090

Study Officials

• Global Director Clinical Development

  Indivior Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: August 17, 2016
• Primary Completion: August 23, 2017
• Study Completion: August 23, 2017
• Last Updated: November 29, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-11

Locations

US (29)