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An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder (NCT02896296)

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.
  • 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.
    • atrigel buprenorphine
  • 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.
    • atrigel buprenorphine
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Provide written consent to participate in this study.
  • Completed the End of Study Visit for the RB-US-13-0003 study.
  • 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 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.
Exclusion Criteria:
  • 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 EOS, 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 C-SSRS "screening/baseline" or history of a suicide attempt (per the C-SSRS) in the 6 months prior to ICF.
  • 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.
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.

29 locations

United States (29)
  • Boyett Health Services
    Not specified
    Hamilton, Alabama, United States, 35570
  • Woodland International Research Group
    Not specified
    Little Rock, Arkansas, United States, 72211
  • Collaborative Neuroscience Network
    Not specified
    Long Beach, California, United States, 90806
  • Pacific Research Partners
    Not specified
    Oakland, California, United States, 94612
  • Sarkis Clinical Trials
    Not specified
    Gainesville, Florida, United States, 32607
  • Amit Vijapura
    Not specified
    Jacksonville, Florida, United States, 32256
  • Meridien Research
    Not specified
    Lakeland, Florida, United States, 33805
  • Innovative Clinical Research
    Not specified
    Lauderhill, Florida, United States, 33319
  • Scientific Clinical Research
    Not specified
    North Miami, Florida, United States, 33161
  • Phoenix Medical Research
    Not specified
    Prairie Village, Kansas, United States, 66206
  • Louisiana Research Associates
    Not specified
    New Orleans, Louisiana, United States, 70114
  • Louisiana Clinical Research
    Not specified
    Shreveport, Louisiana, United States, 71101
  • Stanley Street Treatment and Resources
    Not specified
    Fall River, Massachusetts, United States, 02720
  • Adams Clinical Trials
    Not specified
    Watertown, Massachusetts, United States, 02472
  • Precise Research Centers, Inc.
    Not specified
    Flowood, Mississippi, United States, 39232
  • St Louis Clinical Trials
    Not specified
    Saint Louis, Missouri, United States, 63141
  • Altea Research
    Not specified
    Las Vegas, Nevada, United States, 89102
  • Hassman Research Institute
    Not specified
    Berlin, New Jersey, United States, 08009
  • Center for Emotional Fitness
    Not specified
    Cherry Hill, New Jersey, United States, 08002
  • Neuro-behavioral Clinical Research
    Not specified
    Canton, Ohio, United States, 44708
  • Midwest Clinical Research Center
    Not specified
    Dayton, Ohio, United States, 45417
  • Charak Clinical Research Center
    Not specified
    Garfield Heights, Ohio, United States, 44125
  • Pahl Pharmaceutical Professionals
    Not specified
    Oklahoma City, Oklahoma, United States, 73112
  • SP Research, PLLC
    Not specified
    Oklahoma City, Oklahoma, United States, 73112
  • CODA
    Not specified
    Portland, Oregon, United States, 97232
  • Keystone Clinical Solutions
    Not specified
    Altoona, Pennsylvania, United States, 16601
  • Carolina Clinical Trials
    Not specified
    Charleston, South Carolina, United States, 29407
  • Pillar Clinical Research
    Not specified
    Dallas, Texas, United States, 75243
  • InSite Clinical Research
    Not specified
    DeSoto, Texas, United States, 75115
Status:
completed
Type:
Interventional
Phase:
Start:
16 August, 2016
Updated:
08 October, 2017
Participants:
208
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