Opioid Tapering for Chronic Pain
Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
TW
Terrence Witt, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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
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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
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Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Slow Tapering of Chronic Opioid TherapyExperimental Treatment1 Intervention
Group II: Continued Opioid TherapyActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
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Recruited
3,221,000+
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