Working… Menu

Buprenorphine Treatment: A Safe Alternative for Opioid Dependent Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01841931
Recruitment Status : Terminated (Principal Investigator is no longer at this site)
First Posted : April 29, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
Maimonides Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: Buprenorphine/Naloxone Not Applicable

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. During this period

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Buprenorphine Tx:A Safe Alternative for Opioid Dependent Pain Patients
Study Start Date : February 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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:
    • Buprenorphine
    • Suboxone

Primary Outcome Measures :
  1. Opiate Withdrawal [ Time Frame: 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).

  2. 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 :
  1. 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.

  2. 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.

  3. Positive Affect [ Time Frame: 6 months ]
    The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01841931

Layout table for location information
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Layout table for investigator information
Principal Investigator: Andrew Kolodny, MD Maimonides Medical Center Dept. of Psychiatry Chairman

Additional Information:
Layout table for additonal information
Responsible Party: Maimonides Medical Center Identifier: NCT01841931     History of Changes
Other Study ID Numbers: 11/09/VA05
First Posted: April 29, 2013    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018
Last Verified: July 2013
Keywords provided by Maimonides Medical Center:
Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics, Opioid
Buprenorphine, Naloxone Drug Combination
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists