Patient-Centered Opioid Tapering Study

NCT03303209 | Completed

• 1 other identifier: 37179
• Study Type: observational
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational study of a voluntary opioid tapering protocol conducted in community outpatients taking long term prescription opioids for chronic pain. Patients who would otherwise continue with their existing opioid prescriptions were encouraged to participate in a voluntary opioid taper program. Interested patients were identified by their pain physician, Dr. Richard Stieg, and then completed an online informed consent document and baseline self-report assessments including types and doses of opioid medications as well as demographic and psychosocial measures, clinical and pain characteristics. Patients were either given or mailed a free copy of a patient book The Opioid-Free Pain Relief Kit, or Less Pain, Fewer Pills: Avoid the dangers of prescription opioids and gain control over chronic pain. Over the following weeks and up to 4 months, Dr. Stieg implemented a slow, individually tailored opioid taper in all patient participants. Follow-up online self-report surveys were completed at 4 months post enrollment. Opioid dose data were confirmed via medical chart review, and doses were converted to a standardized morphine equivalent daily dose (MEDD). Main outcome was change in opioid dose baseline to 4 months. Secondary outcome was change in pain intensity (numeric rating scale, 0-10) baseline to 4 months.

Conditions

Chronic Pain; Opioid Use

Keywords

opioid; opioids; taper; chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in Morphine Equivalent Daily Dose (MEDD) from baseline to 4 months.

  Pre-post MEDD change was calculated

  4 months

Secondary Outcomes (1)

• Change in Pain Intensity from baseline to 4 months

  4 months

Interventions

Patient-centered opioid tapering protocol OTHER

All patients who entered the study agreed to partner with their pain physician on a patient-centered opioid tapering program. The research component of the study was to observe patient response (in terms of change in MEDD and pain intensity) at month 4.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain receiving treatment in a community chronic pain clinic who were also taking long term prescription opioids were invited by their prescribing physician to participate in patient-centered, voluntary opioid tapering.

You may qualify if:

• Over age 18
• Chronic pain
• Chronic daily opioids
• Wish to reduce opioid dose

You may not qualify if:

• Not able to communicate in English
• Not able to complete electronic questionnaires
• No major cognitive impairment
• Not actively engaged in treatment for substance use disorder

Sponsors & Collaborators

• Stanford University: lead

Related Publications (4)

• Gomes T, Mamdani MM, Dhalla IA, Paterson JM, Juurlink DN. Opioid dose and drug-related mortality in patients with nonmalignant pain. Arch Intern Med. 2011 Apr 11;171(7):686-91. doi: 10.1001/archinternmed.2011.117.

  PMID: 21482846 BACKGROUND

• Crisostomo RA, Schmidt JE, Hooten WM, Kerkvliet JL, Townsend CO, Bruce BK. Withdrawal of analgesic medication for chronic low-back pain patients: improvement in outcomes of multidisciplinary rehabilitation regardless of surgical history. Am J Phys Med Rehabil. 2008 Jul;87(7):527-36. doi: 10.1097/PHM.0b013e31817c124f.

  PMID: 18574345 BACKGROUND

• Murphy JL, Clark ME, Banou E. Opioid cessation and multidimensional outcomes after interdisciplinary chronic pain treatment. Clin J Pain. 2013 Feb;29(2):109-17. doi: 10.1097/AJP.0b013e3182579935.

  PMID: 22751033 BACKGROUND

• Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28.

  PMID: 27908840 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Beth Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: September 15, 2015
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share