Chronic PainNCT05297396
Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy
A study testing Slow Tapering of Chronic Opioid Therapy in people with Chronic Pain and Opioid Use, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use
- What is being tested?
- Slow Tapering of Chronic Opioid Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2022to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
Mayo Clinic
Eau Claire, Wisconsin, 54703
About this study
Official title: A Pilot Study of Slow Opioid Tapering Compared to Continued Opioid Therapy in Treating Chronic Non-Cancer Pain
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
- Being tested
- Slow Tapering of Chronic Opioid Therapy
- Keywords
- Chronic opioid therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (2)
Change in measures of depression
Measured using the Physical Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-assessment survey which is a reliable and valid measure of depression severity used in both the clinical and research field. Total scores on a scale of 1-27 with higher score indicated higher depression severity.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in measures of anxiety
Measured using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7). The GAD-7 is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Patients indicate one of the 4 numbers (representing severity) associated with 7 problems. Total score symptom range 0-21 with higher score indicated higher anxiety severity.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jul 2022
- Primary completion19 Aug 2024
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence J. Witt, Mayo Clinic
- Investigators
- Terrence Witt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297396
- Sponsor's protocol ID
- 21-009836
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Slow Opioid Tapering Compared to Continued Opioid Therapy in Treating Chronic Non-Cancer Pain
- ClinicalTrials.gov ID
- NCT05297396
- Acronym / sponsor ID
- 21-009836
- Conditions
- Chronic Pain, Opioid Use
- Keywords
- Chronic opioid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow Tapering of Chronic Opioid Therapy | Experimental | Other: Slow Tapering of Chronic Opioid TherapySubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow Tapering of Chronic Opioid TherapyClinically prescribed daily opioids reduced by no more than 10 morphine milligram equivalent per day (MMED) each month for 12 months | Other | Slow Tapering of Chronic Opioid Therapy |
Primary outcome
Changes in measures of quality of life
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
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.
2 secondary outcomes
Change in measures of depression
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in measures of anxiety
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence Witt, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Tapering of Chronic Opioid Therapy in people with Chronic Pain and Opioid Use, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in measures of quality of life (time frame: Baseline, 3 months, 6 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.