Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy

February 13, 2026 updated by: Terrence J. Witt, Mayo Clinic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic Health System - Eau Claire
      • Eau Claire, Wisconsin, United States, 54703
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Slow Tapering of Chronic Opioid Therapy
Subjects who are on a stable dose of daily opioid therapy for at least 6 months will have their opioid medication doses slowly and gradually reduced every 4 weeks.
Other: Slow Tapering of Chronic Opioid Therapy
Clinically prescribed daily opioids reduced by no more than 10 morphine milligram equivalent per day (MMED) each month for 12 months
No Intervention: Continued Opioid Therapy
Subjects who are on a stable dose of daily opioid therapy for at least 6 months will stay on the same dose of opioids they are currently using at the beginning of the study for the entire 12-month duration of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months, 9 months, 12 months
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.
Baseline, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terrence Witt, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-009836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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