Open-label dose-finding trial of buprenorphine implants (Probuphine)(R) for treatment of heroin dependence

White, Jason, Bell, James, Saunders, John B., Williamson, Paul, Makowska, Maria, Farquharson, Aaron and Beebe, Katherine L. (2009) Open-label dose-finding trial of buprenorphine implants (Probuphine)(R) for treatment of heroin dependence. Drug and Alcohol Dependence, 103 1-2: 37-43. doi:10.1016/j.drugalcdep.2009.03.008


Author White, Jason
Bell, James
Saunders, John B.
Williamson, Paul
Makowska, Maria
Farquharson, Aaron
Beebe, Katherine L.
Title Open-label dose-finding trial of buprenorphine implants (Probuphine)(R) for treatment of heroin dependence
Formatted title
Open-label dose-finding trial of buprenorphine implants (Probuphine)® for treatment of heroin dependence
Journal name Drug and Alcohol Dependence   Check publisher's open access policy
ISSN 0376-8716
1879-0046
Publication date 2009-07-01
Sub-type Article (original research)
DOI 10.1016/j.drugalcdep.2009.03.008
Open Access Status
Volume 103
Issue 1-2
Start page 37
End page 43
Total pages 7
Place of publication E. Park, Shannon, Co. Clare, Ireland
Publisher Elsevier Ireland
Language eng
Subject 11 Medical and Health Sciences
1117 Public Health and Health Services
Formatted abstract
Buprenorphine, a μ-opioid receptor partial agonist, has been shown to be safe and effective for treatment of opioid dependence. A novel implantable formulation of buprenorphine (Probuphine®), using a polymer matrix sustained-release technology, has been developed to offer treatment for opioid dependence while minimizing risks of patient noncompliance and illicit diversion. The goal of the current study was to conduct an initial, open-label, evaluation of the safety, pharmacokinetics, and efficacy of two doses of Probuphine in subjects with opioid dependence maintained on sublingual buprenorphine. Two doses of Probuphine were evaluated in 12 heroin-dependent volunteers switched from daily sublingual buprenorphine dosing to either two or four Probuphine implants based upon their buprenorphine daily maintenance dose of 8 mg or 16 mg respectively, and were monitored for 6 months. Probuphine implants provided continuous steady state delivery of buprenorphine until their removal at 6 months. Withdrawal symptoms and craving remained low throughout the 6 months. For the 12 subjects, an average of 59% of urines were opioid-negative across the 6 month treatment period. Injection site reactions were present in half of patients, but none were serious. No safety concerns were evident. These results suggest that Probuphine implants offer significant promise for enhancing delivery of effective opioid substitution treatment while minimizing risk for abuse of medication.
Keyword Sustained-release buprenorphine
Injection depot formulation
Opioid dependence
Implant
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: ERA 2012 Admin Only
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Created: Thu, 03 Sep 2009, 18:00:30 EST by Mr Andrew Martlew on behalf of School of Medicine