Sublingual Buprenorphine for Chronic Pain
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: buprenorphine (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Andrew Rosenblum, PhD, Principal Investigator, Affiliation: NDRI
Overall contact:
Russell K Portenoy, MD, Phone: 212-844-1505, Email: Rportenoy@bethisrael.org
Summary
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.
Clinical Details
Official title: Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse
Study design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: Pain severity
Secondary outcome: Pain behaviors, psychiatric distress, drug use, side effects
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
1. On opioid therapy (any dose) and observed to have had at least four of the aberrant
drug-related behaviors described in (Passik et al. Clin J Pain; 22(2):173-81 2006)
during the past six months, or
2. Considered a candidate for long-term therapy by the pain specialist and a history of
a substance use disorder, as determined by DSM-IV criteria, but no longer meeting
criteria for at least one year.
Age 18-70
Exclusion Criteria:
- Meets DSM-IV criteria for current opioid dependence or other substance use disorder
including alcohol abuse.
- Currently being treated for opioid dependence with methadone.
- Currently maintained on naltrexone (e. g., for alcohol dependence).
- Taking benzodiazepines on a daily basis.
- A history of moderate-severe cardiopulmonary disease or symptoms or signs consistent
with moderate-severe cardiopulmonary disease.
- Elevated liver function test (LFT) results (> 2. 5 above normal).
Locations and Contacts
Russell K Portenoy, MD, Phone: 212-844-1505, Email: Rportenoy@bethisrael.org
Beth Israel Medical Center, New York, New York 10003, United States
Beth Israel Medical Center, New York, New York 10003, United States
Additional Information
Starting date: April 2009
Ending date: August 2009
Last updated: April 6, 2009
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