Sublingual Buprenorphine for Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00612287
Recruitment Status : Unknown
Verified April 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2008
Last Update Posted : April 7, 2009
Beth Israel Medical Center
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: buprenorphine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 : April 2009
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

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 Name: Suboxone®

Primary Outcome Measures :
  1. Pain severity [ Time Frame: 1, 2, 3, 4, 5 & 6 months ]

Secondary Outcome Measures :
  1. Pain behaviors, psychiatric distress, drug use, side effects [ Time Frame: Months 1 through 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612287

Contact: Russell K Portenoy, MD 212-844-1505

United States, New York
Beth Israel Medical Center Not yet recruiting
New York, New York, United States, 10003
Principal Investigator: Russell K Portenoy, MD         
Beth Israel Medical Center Not yet recruiting
New York, New York, United States, 10003
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Beth Israel Medical Center
Principal Investigator: Andrew Rosenblum, PhD NDRI

Responsible Party: Andrew Rosenblum, PhD, National Development and Research Institutes Identifier: NCT00612287     History of Changes
Other Study ID Numbers: R21DA022675 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists