Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: Buprenorphine/Naloxone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Withdrawal | Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction, and will remain withdrawal-free for the entire study duration.Assessed using Clinical Opiate Withdrawal Scale (COWS). | 6 months | 
| Pain Severity | Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI). No results to report. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric Distress | The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being. | 6 months | 
| Quality of Life | Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life. | 6 months | 
| Positive Affect | The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, Dependence, Buprenorphine, Pain