Sublingual Buprenorphine for Chronic Pain

NCT ID: NCT00612287

Last Updated: 2009-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

buprenorphine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Suboxone®

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Medical Center

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

National Development and Research Institutes

Principal Investigators

Andrew Rosenblum, PhD

Role: PRINCIPAL_INVESTIGATOR

NDRI

Locations

Beth Israel Medical Center

New York, New York, United States

Beth Israel Medical Center

New York, New York, United States

Countries

United States

Central Contacts

Russell K Portenoy, MD

Role: CONTACT

Rportenoy@bethisrael.org

212-844-1505

Other Identifiers

R21DA022675

Identifier Type: NIH

Identifier Source: org_study_id

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