Clinical trial NCT05297396: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use
Keywords: Chronic opioid therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in measures of quality of life
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change in measures of depression
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in measures of anxiety
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Eau Claire
country: United States
facility: Mayo Clinic Health System - Eau Claire
state: Wisconsin
city: Eau Claire
country: United States
facility: Mayo Clinic
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Terrence Witt, MD
role: PRINCIPAL_INVESTIGATOR
References: