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Sublingual Buprenorphine for Chronic Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Beth Israel Medical Center
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00612287
First received: February 6, 2008
Last updated: April 6, 2009
Last verified: April 2009
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse

Resource links provided by NLM:


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: April 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  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

  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
Beth Israel Medical Center
Investigators
Principal Investigator: Andrew Rosenblum, PhD NDRI
  More Information

No publications provided

Responsible Party: Andrew Rosenblum, PhD, National Development and Research Institutes
ClinicalTrials.gov Identifier: NCT00612287     History of Changes
Other Study ID Numbers: R21 DA022675
Study First Received: February 6, 2008
Last Updated: April 6, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014