Research Project
PI: Richard N. Rosenthal, MD
Title: PRO-808: An Open-Label, Multi-Center Study Of Probuphine® In Patients With Opioid Dependence
Description:

This is an open label multi-site study examining the safety and efficacy of implantable buprenorphine in the treatment of opioid dependence in n =350 adult outpatients between 18 and 75 years of age, currently diagnosed with opioid dependence and who have NOT received treatment for opioid dependence within the previous 90 days nor treatment for chronic pain with opioid medications. The study will be run at the St. Luke's Hospital Trinity Program and the Behavioral Science Research Unit (BSRU) at St. Luke's Hospital (212) 523-2554. Participants who meet all inclusion criteria and none of the exclusion criteria will be stabilized after two screening visits for up to two weeks on 12–16 mg of sublingual oral buprenorphine. If stable on 12-16 mg of sublingual buprenorphine for at least 3 days, then subjects will be implanted with Probuphine. There will be up to a two-week screening period, followed by 24 weeks of study medication and weekly visits and a follow-up assessment at 14 weeks. At each weekly visit, participants will have their vital signs measured, provide a urine drug screen, be asked about substance use, opioid craving, and possible adverse events, and then be provided with psychosocial counseling.

To learn more about this study, contact the PI at the Department of Psychiatry at St. Luke's Hospital (212) 523-5366.

 

 

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