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NCT01262261 · ClinicalTrials.gov registry record · Phase 3
Re-Treatment Study of Probuphine in Opioid Addiction
A Phase 3 study of Opioid Dependency, sponsored by Titan Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 85
- Enrollment target
- 18
- Study locations
NCT01262261: Completed Phase 3 study of Opioid Dependency, sponsored by Titan Pharmaceuticals.
NCT01262261 is a Phase 3 study of Opioid Dependency that has completed, run by Titan Pharmaceuticals. The registered enrollment target is 85 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01262261, a Phase 3 study of Opioid Dependency, has completed, sponsored by Titan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 85 participants
- Enrollment target
- 18
- Study locations
Study Summary
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.
Primary Outcome
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.
Conditions Studied
Interventions
- DRUG Probuphine (buprenorphine implant)
Study Locations (18)
California
- David Geffen School of Medicine at UCLA - Los Angeles
- Synergy Clinical Research Center - National City
- North County Clinical Research - Oceanside
- Friends Research Institute - Torrance
Florida
- Amit Vijapura, MD - Jacksonville
- Operation PAR, Inc. - TC Campus - Largo
- Fidelity Clinical Research - Lauderhill
- Scientific Clinical Research, Inc. - North Miami
Maryland
- BPRU, Behavioral Biology Research Center - Baltimore
Massachusetts
- Stanley Street Treatment and Resources, Inc - Fall River
Mississippi
- Precise Research Centers - Flowood
Missouri
- Psych Care Consultants Research - St Louis
New York
- St. Luke's Roosevelt Hospital Center - New York
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT01262261 record still lists
NCT01262261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Opioid Dependency appearing as the primary indexed condition, and to 1 intervention - of which Probuphine (buprenorphine implant) is the first listed.
NCT01262261 lists 18 locations in 12 states (California, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT01262261 about?
NCT01262261 is a clinical study titled "Re-Treatment Study of Probuphine in Opioid Addiction". Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who ha...
What is the current status of trial NCT01262261?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 85 participants. The study started on 2010-11. Estimated completion is 2011-11.
What conditions does trial NCT01262261 study?
This clinical trial studies the following conditions: Opioid Dependency.
What interventions are being tested in trial NCT01262261?
The interventions under investigation include: Probuphine (buprenorphine implant) (DRUG).
Who is sponsoring clinical trial NCT01262261?
This trial is sponsored by Titan Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01262261 being conducted?
This trial has 18 study locations across California, Florida, Maryland, Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01262261's enrollment target sits among peer trials
85 1747th of 2000 higher than 252 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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