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NCT03993392 · ClinicalTrials.gov registry record · Phase 4
SUBLOCADE Rapid Initiation Study
A Phase 4 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT03993392: Completed Phase 4 study, sponsored by Indivior.
NCT03993392 is a Phase 4 study that has completed, run by Indivior. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03993392, a Phase 4 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.
Primary Outcome
Clinical Opiate Withdrawal Scale (COWS) is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-
Interventions
- DRUG TM buprenorphine
- DRUG SUBLOCADE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2019-12-26 |
| Phase | Phase 4 |
What the finished NCT03993392 record still lists
NCT03993392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which TM buprenorphine is the first listed.
NCT03993392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03993392 about?
NCT03993392 is a clinical study titled "SUBLOCADE Rapid Initiation Study". This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.
What is the current status of trial NCT03993392?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2019-08-29. Estimated completion is 2019-12-26.
What interventions are being tested in trial NCT03993392?
The interventions under investigation include: TM buprenorphine (DRUG), SUBLOCADE (DRUG).
Who is sponsoring clinical trial NCT03993392?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03993392's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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