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NCT03752528 · ClinicalTrials.gov registry record
Evaluation of Long-term Buprenorphine Plasma Exposure
A clinical trial of Opioid Use Disorder, sponsored by Indivior.
- Completed
- Registry status
- 53
- Enrollment target
- 11
- Study locations
NCT03752528: Completed study of Opioid Use Disorder, sponsored by Indivior.
NCT03752528 is a study of Opioid Use Disorder that has completed, run by Indivior. The registered enrollment target is 53 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03752528, a study of Opioid Use Disorder, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- 53 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
The qualitative UDS (immunoassay) is the primary test used for the initial screening for opioids in patients in clinical practice. It provides only a qualitative assessment of buprenorphine exposure (i.e., positive or negative) with a low limit of quantification (LLOQ) of 5 ng/mL. The qualitative UDS is reported for Part A Cohort (Visit 1) and Part B Cohort (Visits 1, 2 and 3). Participants' last subcutaneous injections of extended release buprenorphine (SUBLOCADE™) was 22 - 38 months prior dur
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 |
What the finished NCT03752528 record still lists
NCT03752528 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
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.
NCT03752528 lists 11 locations in 10 states (Oklahoma, Alabama, Florida).
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.
What interventions are being tested in trial NCT03752528?
The interventions under investigation include: Blood sample collection (DIAGNOSTIC_TEST), Urine sample collection (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03752528?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
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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53 170th of 257 higher than 87 of 257 other Opioid Use Disorder trials
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