Ensayos clínicos

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/31/22. Questions regarding updates should be directed to the study team contact.