Back to resultsSlow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy
Primary Purpose
Chronic Pain, Opioid Use
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow Tapering of Chronic Opioid Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic opioid therapy
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.
Sites / Locations
- Mayo Clinic Health System - Eau Claire
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Slow Tapering of Chronic Opioid Therapy
Continued Opioid Therapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05297396
Brief Title
Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy
Official Title
A Pilot Study of Slow Opioid Tapering Compared to Continued Opioid Therapy in Treating Chronic Non-Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Use
Keywords
Chronic opioid therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Slow Tapering of Chronic Opioid Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Continued Opioid Therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Slow Tapering of Chronic Opioid Therapy
Intervention Description
Clinically prescribed daily opioids reduced by no more than 10 morphine milligram equivalent per day (MMED) each month for 12 months
Primary Outcome Measure Information:
Title
Changes in measures of quality of life
Description
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.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
Change in measures of depression
Description
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.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
Title
Change in measures of anxiety
Description
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.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Witt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System - Eau Claire
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54703
Country
United States
Facility Name
Mayo Clinic
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54703
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
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Slow Opioid Tapering Pilot Study of Patients Using Chronic Opioid Therapy
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