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Opioid Taper Study

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ClinicalTrials.gov Identifier: NCT03912298
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The purpose of this study is to determine the effect of opioid taper on pain sensitivity in patients with chronic pain. In a well-characterized sample of men and women with chronic neuropathic pain on high-dose opioid therapy, experimental pain responses (cold-pressor, quantitative sensory testing) will be serially described over the course of and following an individualized opioid taper. In addition, functional improvements and subject-level predictors of response will be described.

Condition or disease Intervention/treatment
Chronic Pain Other: Opioid Taper Pain perception

Detailed Description:

The overall Specific Aim of this proposal is to determine the effect of opioid taper on pain sensitivity in patients with chronic pain. Specifically, in a well-characterized sample of men and women with chronic neuropathic pain and receiving high-dose opioid therapy (200mg morphine equivalents/day [MED]), experimental pain responses will be serially described over the course of an individualized opioid taper to a safer dose of 90mg MED for up to 12 months. Changes will be inspected within-subject over time, and pain perception will be measured with two valid and reliable experimental pain induction techniques commonly used to measure OIH (cold-pressor, quantitative sensory testing); in addition, related functional improvements and subject-level predictors of response will be described.

Hypothesis 1. Subjects undergoing opioid taper will have improved pain responses over time compared to within-subject baseline as measured by cold-pressor and quantitative sensory pain testing.

Hypothesis 2. Improvements in experimental pain responses will be positively related to improved functional outcomes compared to within-subject baseline as measured by the PROMIS physical, mental and social health measures.

Hypothesis 3. Degree of improvement in experimental pain responses related to opioid taper will be predicted by demographic, pain, and opioid use history characteristics of the subject.

Data showing that pain perception improves as opioids are withdrawn would provide an evidence-based, mechanistic rationale for opioid taper in patients with chronic pain and have the potential to support a sea-change in opioid prescription practices. In that ongoing opioid therapy brings with it significant health risks for the patient and the community, it is critical that empirical evidence of its efficacy be demonstrated to balance the benefits with the risks of adverse events, potential misuse and abuse, and patient safety.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Opioid Taper on Pain Responses in Patients With Chronic Pain
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain


Intervention Details:
  • Other: Opioid Taper Pain perception
    Pain Responses: The primary dependent variable, pain, will be measured using two highly reliable and valid pain induction techniques, the CPT and QST, employing procedures consistent with those described in the literature. Order of pain testing will vary, and three aspects of the pain response will be captured at each study session: evoked pain; temporal summation; and conditioned pain modulation, which map on to the hypothesized peripheral, spinal and supra-spinal mechanisms of OIH. Protocols for each assay have been uploaded.


Primary Outcome Measures :
  1. Pain Perception measured using the cold-pressor test (CPT) [ Time Frame: One year ]
    Pain perception will be measured using the cold-pressor test (CPT) employing procedures consistent with those described in the literature. Order of pain testing will vary, and three aspects of the pain response will be captured at each study session: evoked pain; temporal summation; and conditioned pain modulation, which map on to the hypothesized peripheral, spinal and supra-spinal mechanisms of OIH.

  2. Pain Perception measured using the quantitative sensory testing (QST) [ Time Frame: one year ]
    Pain perception will be measured using the quantitative sensory testing (QST) employing procedures consistent with those described in the literature. Order of pain testing will vary, and three aspects of the pain response will be captured at each study session: evoked pain; temporal summation; and conditioned pain modulation, which map on to the hypothesized peripheral, spinal and supra-spinal mechanisms of OIH.


Secondary Outcome Measures :
  1. Presence of opioid withdrawal symptoms [ Time Frame: One year ]
    The presence of opioid withdrawal symptoms using the well-validated clinical opiate withdrawal scale (COWS) will be assessed. COWS scale is measured with a total score ranging from 15 (mild) to 36 (severe withdrawal).



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The sample will consist of 25 male and female adults with chronic neuropathic pain on opioid therapy and preparing to voluntarily undergo a prescribed opioid taper.
Criteria

Inclusion Criteria:

  1. between ages of 21-70;
  2. documented chronic neuropathic non-malignant pain condition of at least one year duration;
  3. on 200mg MED for at least 6 months;
  4. have fully engaged in all prescribed non-opioid pain management treatments;
  5. willing to undergo prescribed opioid taper;
  6. otherwise in good physical and mental health, or in the care of a physician who is willing to take responsibility for such treatment;
  7. able to understand the purpose and instructions of the study, and provide informed consent as approved by the University of Pennsylvania IRB.

Exclusion Criteria:

  1. meet diagnostic criteria for an active substance use disorder other than nicotine;
  2. be acutely psychotic, severely depressed, and/or in need of inpatient psychiatric treatment,
  3. have a neurological or psychiatric illness that would affect pain responses, including anxiety disorders;
  4. have a history of heart disease, stroke, or a pacemaker or uncontrolled high blood pressure. Good cardiovascular health is stipulated to ensure subjects can tolerate the sympathetic nervous system responses associated with the pain induction procedures.

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 ClinicalTrials.gov identifier (NCT number): NCT03912298


Contacts
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Contact: Margaret A Compton, RN, PhD 215-898-6679 pcompton@nursing.upenn.edu
Contact: Martia Lynch 215-615-0310 Marita.Lynch@uphs.upenn.edu

Locations
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United States, Pennsylvania
Penn Pain Medicine Center Tuttleman Center Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Margaret Compton, RN, PhD       pcompton@nursing.upenn.edu   
Contact: Ignacio Badiola, MD       ignacio.badiola@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Margaret A Compton, RN, PhD University of Pennsylvania

Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03912298     History of Changes
Other Study ID Numbers: 831447
1R21DA046364-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents