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Evaluation of Long-term Buprenorphine Plasma Exposure
NCT03752528 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood sample collection
- DIAGNOSTIC_TEST Urine sample collection
Study Locations (11)
Oklahoma
- Pahl Research — Oklahoma City
- SP Research — Oklahoma City
Alabama
- Pathway Healthcare — Hamilton
Florida
- Meridian Research — Tampa
Kansas
- Phoenix Medical Research — Prairie Village
Massachusetts
- Adams Clinical — Watertown
New Jersey
- Hassman Research Institute — Berlin
Ohio
- Neurobehavioral Clinical Research — North Canton
Oregon
- CODA — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2019-07-18 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03752528
The ClinicalTrials.gov registry entry for NCT03752528 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indivior, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Opioid-use Disorder appearing as the primary indexed condition, and to 2 interventions — of which Blood sample collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03752528 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Oklahoma, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03752528 about?
NCT03752528 is a clinical study titled "Evaluation of Long-term Buprenorphine Plasma Exposure". 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-6000-30...
What is the current status of trial NCT03752528?
This trial is currently completed. The enrollment target is 53 participants. The study started on 2019-02-19. Estimated completion is 2019-07-18.
What conditions does trial NCT03752528 study?
This clinical trial studies the following conditions: Opioid-use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03752528?
The interventions under investigation include: Blood sample collection (DIAGNOSTIC_TEST), Urine sample collection (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03752528?
This trial is sponsored by Indivior, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03752528 being conducted?
This trial has 11 study locations across Alabama, Florida, Kansas, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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