Clinical trial NCT01841931: Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients
Official title: Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioids
Dependence
Buprenorphine
Pain
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether buprenorphine can be at least as effective as other opioid medications in relieving chronic pain in patients who suffer from dependence on their opioid medications, while patients simultaneously experience progressive decline of pain along with absence of opioid withdrawal symptoms and improved quality of life.

Detailed description: The study will utilize sublingual buprenorphine for the treatment of chronic pain patients with co-occurring opioid dependence. Adult male and female chronic pain patients with co-occurring opioid dependence/disorder, being treated at MMC will be enrolled in a home induction procedure. Subjects will be switched from their current opioid pain medication to buprenorphine/naloxone to assess whether buprenorphine is at least as effective, if not more effective, as other opioid medications in controlling their pain while simultaneously improving their psychological distress, functional status, and other aspects of patients' lives. We will utilize a home induction procedure, and maintain subjects on this oral medication for a duration of 6 months. During this period

Eligibility criteria: Inclusion Criteria:

* Meets DSM criteria for opioid dependence (or opioid use disorder when DSM 5 is in use)
* Has received opioid therapy for at least 90 days
* Has opioid dependence as assessed by a Maimonides psychiatrist

Exclusion Criteria:

* Scheduled for major surgery during study duration
* Predicted life expectancy \< 1 year
* Plan to cease habitation in greater New York area within 6 months
* Risks for buprenorphine outweigh potential benefit, as determined by the PI
* Lacks sufficient fluency in English to understand the study protocol, answer survey questions or give informed consent
* Pregnant women

Primary outcomes:
measure: Opiate Withdrawal
timeFrame: 6 months
measure: Pain Severity
timeFrame: 6 months
Secondary outcomes:
measure: Psychiatric Distress
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Positive Affect
timeFrame: 6 months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center Dept. of Psychiatry Chairman
name: Andrew Kolodny, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Lee JD, Grossman E, DiRocco D, Gourevitch MN. Home buprenorphine/naloxone induction in primary care. J Gen Intern Med. 2009 Feb;24(2):226-32. doi: 10.1007/s11606-008-0866-8. Epub 2008 Dec 17.
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