Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients
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ClinicalTrials.gov Identifier: NCT01841931
Recruitment Status :
(Principal Investigator is no longer at this site)
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.
Condition or disease
Opioid Use Disorder
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
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).
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).
Pain Severity [ Time Frame: 6 months ]
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.
Secondary Outcome Measures :
Psychiatric Distress [ Time Frame: 6 months ]
The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.
Quality of Life [ Time Frame: 6 months ]
Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.
Positive Affect [ Time Frame: 6 months ]
The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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