NCT01841931

Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine/Naloxone	Sublingual buprenorphine/naloxone taken in a 3 day induction, with a final daily dose (up to 32 mg depending on the subject) taken daily, as prescribed by the study psychiatrist. Subjects will continue buprenorphine for study duration (6 months).

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2013-04-29
• Last updated: 2018-04-23
• Results posted: 2018-04-23

Locations

1 site across 1 country: United States