Research Project |
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| 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.
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