Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy

NCT ID: NCT05297396

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-01-31

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.

Conditions

Chronic Pain; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Slow Tapering of Chronic Opioid Therapy

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Terrence J. Witt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terrence Witt, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, United States

Mayo Clinic

Eau Claire, Wisconsin, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

21-009836

Identifier Type: -

Identifier Source: org_study_id