Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Opioid Use Disorder; Opioid Dependence
• Intervention / Treatment: Drug: Buprenorphine/Naloxone

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buprenorphine Treatment; 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).	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).; Other Names: Suboxone; Buprenorphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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
Positive Affect	The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).	6 months
Quality of Life, Quality of Life is Measured	Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.	6 months

Collaborators and Investigators

• Sponsor: Theresa Jacob, PhD, MPH
• Investigators: Study Director: Theresa Jacob, PhD, MPH, Maimonides Medical Center

Publications and helpful links

General Publications

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
• TEDS. Treatment Episode Data Set, 1998-2008. Subsance Abuse and Mental Health Services Administration, Office of Applied Studies, http://wwwdasis.samhsa.gov/webt/NewMapv1.htm
• Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994 May;55(5):569-80. doi: 10.1038/clpt.1994.71.
• Rosen CS, Drescher KD, Moos RH, Finney JW, Murphy RT, Gusman F. Six- and ten-item indexes of psychological distress based on the Symptom Checklist-90. Assessment. 2000 Jun;7(2):103-11. doi: 10.1177/107319110000700201.
• Sobell, L.C., & Sobell, M.B., Alcohol Timeline Followback (TFLB), in Handbook or Psychiatric Measures, I.A.P.A. (ed.), Editor. 2000, American Psychiatric Association: Washington, D.C. p. 477-479.
• 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.
• Schilthuizen M, Stouthamer R. Horizontal transmission of parthenogenesis-inducing microbes in Trichogramma wasps. Proc Biol Sci. 1997 Mar 22;264(1380):361-6. doi: 10.1098/rspb.1997.0052.

Helpful Links

• British Pain Society guidelines on prescribing opioids, intended for both doctors and patients.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimated): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Dependence; Opioids; Buprenorphine
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Opioid-Related Disorders; Chronic Pain; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Drug Combinations; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Buprenorphine, Naloxone Drug Combination; Buprenorphine
• Other Study ID Numbers: 11/09/VA05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No