Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

Opioid Use Disorder Clinical Trial

Official title:

Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01841931
• Other study ID #: 11/09/VA05
• Status: Terminated
• Phase: N/A
• First received: January 25, 2013
• Last updated: March 23, 2018
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: July 2013
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder

Intervention

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).

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

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. — View Citation

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. — View Citation

Schilthuizen M, Stouthamer R. Horizontal transmission of parthenogenesis-inducing microbes in Trichogramma wasps. Proc Biol Sci. 1997 Mar 22;264(1380):361-6. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Positive Affect	The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).	6 months

External Links

•   British Pain Society guidelines on prescribing opioids, intended for both doctors and patients.
•   direct link to PDF of home induction packet used in study (NYU school of medicine version from study by Lee et. al.)