Sublingual Buprenorphine for Chronic Pain

Official Title: “Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse”

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary Measures

• Pain severity
  • Time Frame: 1, 2, 3, 4, 5 & 6 months
    Safety Issue?: No

Secondary Measures

• Pain behaviors, psychiatric distress, drug use, side effects
  • Time Frame: Months 1 through 6
    Safety Issue?: Yes

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

Andrew Rosenblum, PhD Principal Investigator NDRI  

Overall Contact: Russell K Portenoy, MD 212-844-1505 Rportenoy@bethisrael.org

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612287

Study ID Number: R21 DA022675

ClinicalTrials.gov Identifier: NCT00612287

Health Authority: United States: Food and Drug Administration