A Phase 2 interventional study of buprenorphine in Chronic Pain, sponsored by National Institute on Drug Abuse (NIDA). Status unknown at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-04-07.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment
The purpose of this study is to develop and pilot test clinical guidelines for the use of buprenorphine for the treatment chronic pain among patients with substance abuse histories. Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because, compared to most other opioid analgesics, it has a high safety profile, a low level of physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising reports from Europe of its use as a skin patch to treat chronic pain as well as clinical reports in the U.S. that it may be effective when used sublingually (placed under the tongue). This study will test the sublingual formulation.
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the Department of Pain and Palliative Medicine Beth Israel Medical Center in New York City or the the Peter Kruger Clinic at the same institution.
Either
Age 18-70
Exclusion Criteria:
Drug: buprenorphine
Sublingual buprenorphine; product name Suboxone® (buprenorphine/naloxone). Dosing is informed by a clinical guideline which permits flexibility dependent up physician's clinical judgment. During the induction period (Day 1, at the physician's office) the first dose is 2 mg and can be brought up to 20 mg depending on patient's response. On Day 2 going forward dose can range from 2 mg q8h to 12 mg q8h. Rescue doses with buprenorphine are also permitted.
Also known as: Suboxone®
Pain severity
Time frame: 1, 2, 3, 4, 5 & 6 months
Pain behaviors, psychiatric distress, drug use, side effects
Time frame: Months 1 through 6
This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)