Opioid Tapering for Chronic Pain

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Opioids

Must not be taking: Methadone, Buprenorphine, Benzodiazepines, others

Disqualifiers: Active cancer, Pregnancy, Suicidal intent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

22 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Terrence Witt, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for patients under chronic opioid therapy for pain, prescribed by MCHS NW WI, with a daily dose ≤90 MME using specific opioids in tablet/capsule form. Participants must be able to consent and commit to the study's requirements. Exclusions include active/planned pregnancy, cancer treatment (except certain skin cancers), non-chronic pain opioid use, hospice care, recent suicidal intent or misuse of controlled medications.

Inclusion Criteria

I take 90mg or less of pain medication daily.

My doctor agrees with me joining the trial and prescribes opioids for chronic pain.

Ability to provide consent

Exclusion Criteria

I am currently using methadone or buprenorphine.

I am currently undergoing or planning to start cancer treatment, excluding hormonal therapy and treatments for non-melanoma skin cancers.

Known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either continued opioid therapy or undergo slow tapering of opioid doses

12 months

Visits at baseline, 3 months, 6 months, 9 months, and 12 months

Follow-up

Participants are monitored for changes in pain, quality of life, depression, and anxiety

4 weeks

Treatment Details

Interventions

• Slow Tapering of Chronic Opioid Therapy

Trial Overview The study tests if very slow tapering of opioids worsens pain, quality of life, depression or anxiety in patients on stable long-term doses for chronic pain. It aims to understand the effects of reducing opioid medication gradually over time.

Participant Groups

Group I: Slow Tapering of Chronic Opioid Therapy Experimental Treatment 1 Intervention

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.

Group II: Continued Opioid Therapy Active Control 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+