Sublingual Buprenorphine for Chronic Pain

Phase 2

• Conditions: Chronic Pain
• Interventions: Drug: buprenorphine

• Registration Number: NCT00612287
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-11
• Status Verified: 2009-04
• Study Start: 2009-04
• Last Update Submitted: 2009-04-06
• Last Update Posted: 2009-04-07
• Primary Completion: 2009-05
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	buprenorphine	-

Primary Outcome Measures

Name	Time	Method
Pain severity	1, 2, 3, 4, 5 & 6 months

Secondary Outcome Measures

Name	Time	Method
Pain behaviors, psychiatric distress, drug use, side effects	Months 1 through 6

Trial Locations

Locations (1)

Beth Israel Medical Center; 🇺🇸 New York, New York, United States