Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Maimonides Medical Center

Status: Terminated

Conditions: Opioid Use Disorder

Treatments: Drug: Buprenorphine/Naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT01841931

11/09/VA05

Details and patient eligibility

About

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.

Full 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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)