Open-Label Treatment Extension Study

NCT ID: NCT02896296

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2017-08-23

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.

Detailed Description

This is a multi-center, open-label, RBP-6000 treatment extension study in which subjects who have completed the End of Study (EOS) procedures for study RB-US-13-0003 are eligible. EOS assessments completed at the RB-US-13-0003 EOS visit serve as part of the screening visit for this study. In addition, subjects were requested to complete a Columbia Suicide Severity Rating Scale (C-SSRS) baseline/screening survey and a medical history and height was obtained.

The informed consent may be shared with subjects up to 2 months prior to the RB-US-13-0003 EOS visit, however should not be signed until all assessments for the EOS visit have been completed.

On Day 1, eligible subjects receive a subcutaneous (SC) injection of RBP-6000 at a low or high dose based on the medical judgment of the investigator. After the injection, vital signs and the injection site were assessed. Prior to departing the site, subjects were also assessed for adverse events (AEs) and use of concomitant medications (ConMeds).

Subjects return 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). At each subsequent visit (Injections 2 through 6) the following procedures / assessments were performed : urine pregnancy test performed for all female subjects who are of childbearing potential before each injection; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; vital signs collected pre and post each injection; RBP-6000 injection, urine drug screen (UDS); C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; local injection site grading, subject self-assessment of injection site pain (Injection Site Pain Visual Analog Scale [VAS]), assessment for adverse events (AEs).

Laboratory tests (hematology, chemistry and urinalysis) may be requested by the Investigator on an ad-hoc basis in order to assess for AEs.

A subject's alternative treatment options were assessed at least two months before EOS at each visit.

At EOS or early termination (ET), the following assessments were performed: urine pregnancy test performed for all female subjects who are of childbearing potential; vital signs; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; UDS; C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; assessment for AEs; a brief physical exam; height and body weight were measured and a subject's body mass index (BMI) and waist-to-hip ratio calculated; laboratory tests (hematology, chemistry, urinalysis).

Subjects were to be contacted by telephone approximately 4 weeks after EOS/ET for a safety follow-up assessment of AEs and use of ConMeds.

Conditions

Opioid Use Disorder; Opioid-related Disorders

Study Design

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

Study Groups

RBP-6000 (100/300 mg Flex)

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.

Group Type: EXPERIMENTAL

RBP-6000

Intervention Type: 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.

Interventions

RBP-6000

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.

Intervention Type: DRUG

Other Intervention Names

atrigel buprenorphine; extended-release buprenorphine

Eligibility Criteria

Inclusion Criteria

1. Provide written consent to participate in this study.

2. Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).

3. Be considered eligible in the medical judgment of the Investigator.

4. 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.

5. Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.

6. Subjects must be willing to adhere to study procedures.

Exclusion Criteria

1. Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.

2. 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.

3. 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.

4. 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.

• 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

Boyett Health Services

Hamilton, Alabama, United States

Woodland International Research Group

Little Rock, Arkansas, United States

Collaborative Neuroscience Network

Long Beach, California, United States

Pacific Research Partners

Oakland, California, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Amit Vijapura

Jacksonville, Florida, United States

Meridien Research

Lakeland, Florida, United States

Innovative Clinical Research

Lauderhill, Florida, United States

Scientific Clinical Research

North Miami, Florida, 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

Hassman Research Institute

Berlin, New Jersey, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Neuro-behavioral Clinical Research

Canton, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Rakesh Ranjan MD & Associates, Inc.

Garfield Heights, Ohio, United States

Pahl Pharmaceutical Professionals

Oklahoma City, Oklahoma, United States

SP Research, PLLC

Oklahoma City, Oklahoma, United States

CODA

Portland, Oregon, United States

Keystone Clinical Solutions

Altoona, 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

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

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INDV-6000-301

Identifier Type: -

Identifier Source: org_study_id