Opioid Taper Study

NCT03912298 | Completed Results

• 2 other identifiers: 8314471R21DA046364-01A1
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Pain Perception Measured Using the Cold-pressor Test (CPT)

  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. Reported are cold-pressor pain tolerance prior to and following taper.

  up to one year (length of taper individualized and varies)

• Conditioned Pain Modulation Measured Using the Quantitative Sensory Testing (QST)

  Conditioned pain modulation will be measured using the quantitative sensory testing (QST) employing procedures consistent with those described in the literature to capture supra-spinal mechanisms of OIH. To detect conditioned modulation, the subject is asked to verbally report the severity of pain experienced on a visual analogue scale (0- no pain, 10-worst pain ever) to a three-second painful heat stimulus (47○C) delivered at 12-15 second intervals, in the presence or absence of the non-dominant limb being immerged in a cold-water bath (12○C). The reported value is the difference between the average of pain scores reported in the absence of vs. the presence of the counter-stimulation. Reported are changes in the conditioned pain modulation assay both prior to and following taper. Taper is individualized thus length of taper varies between subjects.

  up to one year (individualized, variable taper length)

Interventions

Opioid Taper Pain perception OTHER

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.

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• between ages of 21-70;
• documented chronic neuropathic non-malignant pain condition of at least one year duration;
• on \>100mg/day MED for at least 6 months;
• have fully engaged in all prescribed non-opioid pain management treatments;
• willing to undergo prescribed opioid taper;
• otherwise in good physical and mental health, or in the care of a physician who is willing to take responsibility for such treatment;
• able to understand the purpose and instructions of the study, and provide informed consent as approved by the University of Pennsylvania IRB.

You may not qualify if:

• meet diagnostic criteria for an active substance use disorder other than nicotine;
• be acutely psychotic, severely depressed, and/or in need of inpatient psychiatric treatment,
• have a neurological or psychiatric illness that would affect pain responses, including anxiety disorders;
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Penn Pain Medicine Center Tuttleman Center

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (4)

• Dowell D, Haegerich TM. Changing the Conversation About Opioid Tapering. Ann Intern Med. 2017 Aug 1;167(3):208-209. doi: 10.7326/M17-1402. Epub 2017 Jul 11. No abstract available.

  PMID: 28715842 BACKGROUND

• Peles E, Schreiber S, Hetzroni T, Adelson M, Defrin R. The differential effect of methadone dose and of chronic pain on pain perception of former heroin addicts receiving methadone maintenance treatment. J Pain. 2011 Jan;12(1):41-50. doi: 10.1016/j.jpain.2010.04.009. Epub 2010 Jun 19.

  PMID: 20561825 BACKGROUND

• Wang H, Fischer C, Chen G, Weinsheimer N, Gantz S, Schiltenwolf M. Does long-term opioid therapy reduce pain sensitivity of patients with chronic low back pain? Evidence from quantitative sensory testing. Pain Physician. 2012 Jul;15(3 Suppl):ES135-43.

  PMID: 22786452 BACKGROUND

• Compton P, Halabicky OM, Aryal S, Badiola I. Opioid Taper is Associated with Improved Experimental Pain Tolerance in Patients with Chronic Pain: An Observational Study. Pain Ther. 2022 Mar;11(1):303-313. doi: 10.1007/s40122-021-00348-8. Epub 2022 Jan 12.

  PMID: 35020185 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peggy Compton
• Organization: University of Pennsylvania

pcompton@nursing.upenn.edu

2158986679

Study Officials

• Margaret A Compton, RN, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 11, 2019
• Study Start: April 15, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: February 7, 2022
• Results First Posted: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)