Slow Opioid Tapering Pilot Study of Patients Using Chroni... | NCT05297396

NCT05297396

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slow Tapering of Chronic Opioid Therapy	Other	Clinically prescribed daily opioids reduced by no more than 10 morphine milligram equivalent per day (MMED) each month for 12 months

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline, 3 months, 6 months, 9 months, 12 months

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Health System - Eau Claire		Eau Claire	Wisconsin	54703	United States
Mayo Clinic

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms