Sublingual Buprenorphine for Chronic Pain

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00612287

Collaborator

Beth Israel Medical Center (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: buprenorphine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse

Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

May 1, 2009

Anticipated Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	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. Other Names: Suboxone®

Arm

Intervention/Treatment

Experimental: A

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.

Other Names:

Suboxone®

Outcome Measures

Primary Outcome Measures

Pain severity [1, 2, 3, 4, 5 & 6 months]

Secondary Outcome Measures

Pain behaviors, psychiatric distress, drug use, side effects [Months 1 through 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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
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).