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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Beth Israel Medical Center |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00612287 |
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.
Condition | Intervention | Phase |
Chronic Pain |
Drug: buprenorphine |
Phase II |
Drug Information available for: | Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse |
Estimated Enrollment: | 40 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
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.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contact: Russell K Portenoy, MD | 212-844-1505 | Rportenoy@bethisrael.org |
United States, New York | |||||
Beth Israel Medical Center | |||||
New York, New York, United States, 10003 | |||||
Beth Israel Medical Center | |||||
New York, New York, United States, 10003 |
National Institute on Drug Abuse (NIDA) |
Beth Israel Medical Center |
Principal Investigator: | Andrew Rosenblum, PhD | NDRI |
Responsible Party: | National Development and Research Institutes ( Andrew Rosenblum, PhD ) |
Study ID Numbers: | R21 DA022675 |
First Received: | February 6, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00612287 |
Health Authority: | United States: Food and Drug Administration |
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