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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 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.

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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.

Conditions Studied

Opioid Use Disorder

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

FieldValue
Enrollment Target 53 participants
Start Date 2019-02-19
Est. Completion 2019-07-18

Sponsor

Indivior

37 total trials

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What the Registry Record Tells You About NCT03752528

The ClinicalTrials.gov registry entry for NCT03752528 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 10 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.