Trials / Completed
CompletedNCT01114308
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 287 (actual)
- Sponsor
- Titan Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Probuphine (buprenorphine implant) | Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. |
| DRUG | placebo implant | Implant contains ethylene vinyl acetate |
| DRUG | Buprenorphine | sublingual buprenorphine/naloxone tablets |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2010-05-03
- Last updated
- 2018-12-31
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01114308. Inclusion in this directory is not an endorsement.