Sublingual Buprenorphine for Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00612287
• Other study ID #: R21DA022675
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 6, 2008
• Last updated: April 6, 2009
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: April 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: Russell K Portenoy, MD
• Phone: 212-844-1505
• Email: Rportenoy[@]bethisrael.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York
United States	Beth Israel Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity		1, 2, 3, 4, 5 & 6 months	No
Secondary	Pain behaviors, psychiatric distress, drug use, side effects		Months 1 through 6	Yes