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Open-Label Treatment Extension Study

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ClinicalTrials.gov Identifier: NCT02896296
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

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

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Opioid-related Disorders Drug: Low dose RBP-6000 Drug: High dose RBP-6000 Phase 3

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 will serve as the screening visit for this study. In addition, subjects will be requested to complete a Columbia Suicide Severity Rating Scale (C-SSRS) baseline survey and a medical history will be 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 will receive a subcutaneous (SC) injection of RBP-6000 at a low or high dose based on the medical judgment and discretion of the investigator. After the injection, vital signs and the injection site will be assessed. Prior to departing the site, subjects will also be assessed for adverse events (AEs) and use of concomitant medications (ConMeds).

Subjects will return to the site for monthly injection visits every 28 days (-2 / +7 days) for a total of up to 6 injections. At each subsequent visit (Injections 2 through 6) the following procedures / assessments will be performed : urine pregnancy test will be performed for all female subjects who are of childbearing potential before each injection; previous injection site will be assessed for potential reaction and evidence of attempts to remove the depot; vital signs will be 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; assessment for 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 should be assessed at least two months before EOS at each visit.

At EOS, the following assessments will be performed: urine pregnancy test will be performed for all female subjects who are of childbearing potential; vital signs; previous injection site will be 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 will be measured and a subject's body mass index (BMI) and hip to waist ratio will be calculated; laboratory tests (hematology, chemistry, urinalysis).

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder
Actual Study Start Date : August 17, 2016
Actual Primary Completion Date : August 23, 2017
Actual Study Completion Date : August 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose RBP-6000
Subjects completing EOS visit of the RB-US-13-0003 study will receive low dose RBP-6000 for up to 6 monthly injections. At each visit, safety assessments will be completed as defined above. Alternative treatment options should be assessed at least 2 months prior to EOS.
Drug: Low dose 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.
Other Name: atrigel buprenorphine

Experimental: High Dose RBP-6000
Subjects completing EOS visit of the RB-US-13-0003 study will receive high dose RBP-6000 for up to 6 monthly injections. At each visit, safety assessments will be completed as defined above. Alternative treatment options should be assessed at least 2 months prior to EOS.
Drug: High dose 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.
Other Name: atrigel buprenorphine




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 6 months ]
    To assess the frequency of all AEs, serious AEs and discontinuations due to AEs



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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 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 EOS, 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 C-SSRS "screening/baseline" or history of a suicide attempt (per the C-SSRS) in the 6 months prior to ICF.
  4. Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or OTC and herbal supplements with the potential to prolong QTc as per section 6.10.1 within 28 days of Day 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896296


  Show 29 Study Locations
Sponsors and Collaborators
Indivior Inc.
Investigators
Study Director: Global Director Clinical Development Indivior Inc.

Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT02896296     History of Changes
Other Study ID Numbers: INDV-6000-301
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Disease
Opioid-Related Disorders
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists