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Completed

NCT Number: NCT05297396

Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy

The purpose of this study is to find out if patients who have been taking a stable dose of opioids for chronic pain would experience any worsening pain, quality of life and functioning, as well as symptoms of depression and anxiety if their opioid medications are gradually and very slowly reduced.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Eau Claire, Wisconsin, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide consent.
  • Ability to participate in all aspects of this study.
  • Using tablet or capsule form of one or two of the designated opioid preparations daily (at least 95% of days) during the previous 6 months, anticipated long term use and no active plans for tapering. Specific opioid preparations designated for inclusion will be based on the frequency of use by patients on the Chronic Opioid Registry as well as tablet or capsule characteristics which allow encapsulation by the Research Pharmacy. Participants who have been prescribed the following oral opioids will be recruited into the study: tramadol 50mg tablet or capsule; hydrocodone-acetaminophen (APAP) 5mg-325mg tablet or capsule; hydrocodone-APAP 7.5mg-325mg tablet or capsule; hydrocodone-APAP 10mg-325mg tablet or capsule; oxycodone 5mg tablet or capsule; oxycodone 10mg tablet or capsule; oxycodone-APAP 5mg-325mg tablet or capsule; oxycodone 10mg-325mg tablet or capsule; morphine sulfate extended release 15mg tablet or capsule; morphine sulfate extended release 30mg tablet or capsule; morphine sulfate immediate release 15mg tablet or capsule; morphine sulfate immediate release 30mg tablet or capsule.
  • Primary care provider prescribing chronic opioid therapy within MCHS NW WI and in agreement with patient participation.
  • Average daily morphine milligram equivalent (MME) dose at enrollment equal to or less than 90.

Exclusion criteria

  • Daily or intermittent use of transdermal, liquid, intravenous or intramuscular forms of opioid during the last 6 months.
  • Use of methadone or buprenorphine.
  • Use of an opioid containing preparation with three or more active ingredients.
  • Active cancer treatment, other than non-melanoma dermatological cancers. This includes patients either currently receiving or planning to receive any type of cancer treatment other than hormonal therapy.
  • Active or planned pregnancy.
  • COT being prescribed for indications other than chronic non-cancer pain (i.e., restless leg syndrome).
  • Enrollment in hospice care.
  • Active suicidal planning or intent as reported on PHQ9.
  • Acquisition of controlled medications from clinicians other than PCP or associated clinicians in the previous 6 months as noted in the Prescription Drug Monitoring Program.
  • Use of opioids and/or benzodiazepines other than those prescribed by PCP or associated clinicians, or the use of illicit substances other than THC, as found in urine drug testing within the previous 6 months.
  • Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Treatment and study plan

Slow Tapering of Chronic Opioid Therapy

Other

Clinically prescribed daily opioids reduced by no more than 10 morphine milligram equivalent per day (MMED) each month for 12 months

Primary outcomes

  1. Changes in measures of quality of life

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

    Measured by the Medical Outcomes Study Questionnaire Short Form Health 36 Survey (SF36v2).The SF-36 is a multi-purpose self-reported survey designed to capture adult patients' perceptions of their own health and well-being.

Secondary outcomes

  1. Change in measures of depression

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

    Measured using the Physical Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-assessment survey which is a reliable and valid measure of depression severity used in both the clinical and research field. Total scores on a scale of 1-27 with higher score indicated higher depression severity.

  2. Change in measures of anxiety

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

    Measured using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7). The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Patients indicate one of the 4 numbers (representing severity) associated with 7 problems. Total score symptom range 0-21 with higher score indicated higher anxiety severity.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Study of Slow Opioid Tapering Compared to Continued Opioid Therapy in Treating Chronic Non-Cancer Pain

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Mar 28, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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