Evaluation of Long-term Buprenorphine Plasma Exposure
Public ClinicalTrials.gov record NCT03752528. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of Long-term Buprenorphine Plasma Exposure in Subjects Who Received at Least 2 Subcutaneous (SC) Injections of Extended-release Buprenorphine (SUBLOCADE™) in Phase III Studies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03752528
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Interventions
- Blood sample collection Diagnostic Test
- Urine sample collection Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 19, 2019 (Actual)
- Primary completion
- Jul 18, 2019 (Actual)
- Completion
- Jul 18, 2019 (Actual)
- Last update posted
- Aug 21, 2020
2019
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pathway Healthcare | Hamilton | Alabama | 35570 | — |
| Meridian Research | Tampa | Florida | 33606 | — |
| Phoenix Medical Research | Prairie Village | Kansas | 66208 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Neurobehavioral Clinical Research | North Canton | Ohio | 44720 | — |
| Pahl Research | Oklahoma City | Oklahoma | 73112 | — |
| SP Research | Oklahoma City | Oklahoma | 73112 | — |
| CODA | Portland | Oregon | 97232 | — |
| Clinical Research Associates of Central PA, LLC | Altoona | Pennsylvania | 16602 | — |
| Pillar Research | Richardson | Texas | 75080 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03752528, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03752528 live on ClinicalTrials.gov.