N/A
Completed N=53
Evaluation of Long-term Buprenorphine Plasma Exposure
Source: ClinicalTrials.gov NCT03752528 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B — 27; 19; 16; 15 Participants
Summary
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.
This multicentre investigation will enroll participants from Study RB-US-13-0003 (NCT02510014) or both Studies RB-US-13-0003 and INDV-6000-301 (NCT02896296) and who received at least 2 subcutaneous (SC) injections of SUBLOCADE.
There are two parts to the study:
Part A consists of a single visit during which urine samples are collected to measure free buprenorphine and free norbuprenorphine concentrations; qualitative urine drug samples (UDS) for opioids, including buprenorphine; quantitative UDS for buprenorphine, norbuprenorphine and naloxone; and determination of creatinine concentration. Blood samples are collected for the determination of buprenorphine and norbuprenorphine plasma concentrations.
Results on the quantitative UDS performed in Part A determine enrollment in Part B: participants who provide a quantifiable (i.e., positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e., negative) result for naloxone meet continuation criteria to move on to Part B if Part B is still open to enrolment. Part B consists of two visits 30 days apart in which the same tests are run as were done in Part A.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative Urinary Drug Screen (UDS) for Buprenorphine in Parts A + B |
27; 19; 16; 15; 22; 5 | — |
| PRIMARY Quantitative Urine Drug Screen (UDS) for Buprenorphine and Norbuprenorphine in Parts A + B |
31; 23; 19; 17; 18; 1 | — |
| PRIMARY Urine Free Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B |
30; 19; 17; 17; 19; 5 | — |
| PRIMARY Plasma Drug Test for Buprenorphine and Norbuprenorphine in Parts A + B |
32; 20; 18; 16; 15; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Participated in Study RB-US-13-0003 or both Studies RB-US-13-0003 and INDV-6000-301 and received at least 2 subcutaneous (SC) injections of SUBLOCADE
- Within 12 to 36 months post his or her last SUBLOCADE injection at the time of the Screening Visit
- Female individuals of childbearing potential must agree to have a pregnancy test administered prior to enrollment and throughout the study. Pregnancy does not prohibit participation
- Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.
Exclusion Criteria
- Received SUBLOCADE or any other long-acting buprenorphine product at any time after ending their participation in Study RB-US-13-0003 or Study INDV-6000-301
- Taken any buprenorphine (prescribed or illicit) within 3 weeks prior to the Screening visit (study Part A, Visit 1)
Data sourced from ClinicalTrials.gov (NCT03752528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.