Status:
ACTIVE_NOT_RECRUITING
Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy
Lead Sponsor:
Mayo Clinic
Conditions:
Chronic Pain
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
NA
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 sym...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05297396
Start Date
July 1 2022
End Date
January 31 2026
Last Update
January 9 2026
Active Locations (2)
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1
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, United States, 54703
2
Mayo Clinic
Eau Claire, Wisconsin, United States, 54703