NCT05297396

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

March 17, 2022

Last Update Submit

February 13, 2026

Conditions

Chronic PainOpioid Use

Keywords

Chronic opioid therapy

Outcome Measures

Primary Outcomes (1)

  • Changes in measures of quality of life

    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 Outcomes (2)

  • Change in measures of depression

    Baseline, 3 months, 6 months, 9 months, 12 months

  • Change in measures of anxiety

    Baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

Slow Tapering of Chronic Opioid Therapy

EXPERIMENTAL

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

Continued Opioid Therapy

NO INTERVENTION

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.

Interventions

Slow Tapering of Chronic Opioid TherapyOTHER

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

Slow Tapering of Chronic Opioid Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide consent.
  • Ability to participate in all aspects of this study.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, 54703, United States

Location

Mayo Clinic

Eau Claire, Wisconsin, 54703, United States

Location

Related Links

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Terrence Witt, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

July 1, 2022

Primary Completion

August 19, 2024

Study Completion

January 31, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)