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NCT02559973 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder

A Phase 1 study, sponsored by Indivior.

Completed
Registry status
Phase 1
Development phase
47
Enrollment target

NCT02559973: Completed Phase 1 study, sponsored by Indivior.

NCT02559973 is a Phase 1 study that has completed, run by Indivior. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02559973, a Phase 1 study, has completed, sponsored by Indivior.

COMPLETED
Registry status
Phase 1
Development phase
47 participants
Enrollment target

Study Summary

This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.

Primary Outcome

Relative bioavailability will be assessed using AUC0-28days.

Interventions

  • DRUG RBP-6000
  • DRUG SUBOXONE Sublingual Film

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2015-09
Est. Completion 2016-03
Phase Phase 1
Indivior

37 total trials

What the finished NCT02559973 record still lists

NCT02559973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).

The record links to 0 conditions, and to 2 interventions - of which RBP-6000 is the first listed.

NCT02559973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02559973 about?

NCT02559973 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder". This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Resident...

What is the current status of trial NCT02559973?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2015-09. Estimated completion is 2016-03.

What interventions are being tested in trial NCT02559973?

The interventions under investigation include: RBP-6000 (DRUG), SUBOXONE Sublingual Film (DRUG).

Who is sponsoring clinical trial NCT02559973?

This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02559973's enrollment target sits among peer trials

47 1053rd of 2000 higher than 943 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02559973, the US trial registry maintained by the National Library of Medicine. NCT02559973 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.