Sublingual Buprenorphine for Chronic Pain - Full Text View

Purpose

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	Intervention	Phase
Chronic Pain	Drug: buprenorphine	Phase II

Drug Information available for:

Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study

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

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Pain severity [ Time Frame: 1, 2, 3, 4, 5 & 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain behaviors, psychiatric distress, drug use, side effects [ Time Frame: Months 1 through 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

A: Experimental

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612287

Contacts


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

Locations


United States, New York
	Beth Israel Medical Center
	New York, New York, United States, 10003
	Beth Israel Medical Center
	New York, New York, United States, 10003

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Beth Israel Medical Center

Investigators


Principal Investigator:	Andrew Rosenblum, PhD	NDRI

More Information

Responsible Party:	National Development and Research Institutes ( Andrew Rosenblum, PhD )
Study ID Numbers:	R21 DA022675
First Received:	February 6, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00612287
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

Pain

Chronic pain

Buprenorphine

Drug addiction

Study placed in the following topic categories:

Buprenorphine

Behavior, Addictive

Pain

Naloxone

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Narcotic Antagonists

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Beth Israel Medical Center
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00612287