Status:
UNKNOWN
Sublingual Buprenorphine for Chronic Pain
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
Beth Israel Medical Center
Conditions:
Chronic Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00612287
Start Date
April 1 2009
End Date
August 1 2009
Last Update
April 7 2009
Active Locations (2)
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1
Beth Israel Medical Center
New York, New York, United States, 10003
2
Beth Israel Medical Center
New York, New York, United States, 10003