NCT01114308

A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence

Completed Phase 3 Last updated 27 December 2018

What this trial tests

Phase 3 trial testing Probuphine (buprenorphine implant) in Opioid Dependency in 287 participants. Completed in 1 May 2011.

Timeline

1 April 2010

Primary endpoint
1 May 2011

1 May 2011

Quick facts

Lead sponsor	Titan Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	287
Start date	1 April 2010
Primary completion	1 May 2011
Estimated completion	1 May 2011
Sites	20 locations across United States

Drugs / interventions tested

• Probuphine (buprenorphine implant) — full drug profile →
• placebo implant
• Buprenorphine (BUPRENORPHINE) — full drug profile →

Conditions studied

• Opioid Dependency — all drugs for Opioid Dependency →

Sponsor

Titan Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Dependency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24
  Time frame: 1-24 weeks
• CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups
  Time frame: 1-24 weeks

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone.
   Rosenthal RN, Ling W, Casadonte P, Vocci F, et al · · 2013 · cited 70× · PMID 23919595 · DOI 10.1111/add.12315
2. Probuphine® (buprenorphine implant): a promising candidate in opioid dependence.
   Barnwal P, Das S, Mondal S, Ramasamy A, et al · · 2017 · cited 21× · PMID 28348732 · DOI 10.1177/2045125316681984