Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
Condition: Chronic Pain; Opioid Use; Deglutition
MeSH terms: Deglutition Disorders; Chronic Pain
Intervention: Xtampza ER (oxycodone)
Intervention description: Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.
Intervention MeSH terms: Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Abuse-deterrent opioid drugs; Xtampza ER

Summary:

      This study will examine how the use of Xtampza ER, an opioid analgesic packaged in openable
      microsphere-containing capsules, affects swallowing satisfaction, pain, and physical and
      mental health outcomes in chronic pain patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult subjects must have noncancer chronic pain for at least six months on a daily
             basis,

          2. Be prescribed opioids on a daily basis

          3. Have an upper dose limit of daily opioids of 200 mg of morphine equivalents. This is
             because at doses greater than 200 mg daily, in the investigator's experience it is
             much more difficult to convert completely to another opioid compound within a week.
             Fentanyl and methadone users will not be specifically excluded unless their dosages
             fall outside this range.

          4. Ages 21-70

          5. Reported difficulty swallowing their opioid medication on the screening form at a
             level determined significant by the PI.

          6. Having a mobile phone. A smart phone is not required to respond to the text messages.

          7. Having Internet access to be able to respond to the emailed weekly surveys.

          8. If sexually active and able to become pregnant, must agree to use an acceptable method
             of birth control (hormonal methods, barrier methods with spermicide, intrauterine
             device (IUD) or abstinence).

          9. Only Pain Medicine Clinic patients may participate in this study

        Exclusion Criteria:

          1. Inability to understand the surveys and complete them.

          2. Pregnancy

          3. High risk for opioid addiction and/or abuse behaviors

          4. Any condition, physical or mental, that in the investigator's judgment precludes
             optimal participation in the study procedures. This includes any documented current
             history of liver disease, renal insufficiency, delirium, alcohol use disorder,
             breast-feeding mothers, acute or severe asthma, chronic obstructive pulmonary disease
             requiring home oxygen, GI obstruction, biliary tract disease, pancreatitis, cardiac
             arrhythmia, bladder or urethral obstruction, adrenal insufficiency, psychosis, or
             taking medications which are potent inhibitors of the CYP3A4 enzyme (such as protease
             inhibitors, macrolide antibiotics, or antifungals).

          5. Demonstration of abusive alcohol behavior. For women, this is more than 3 drinks on
             any single day or more than 7 drinks per week. For men, more than 4 drinks on any
             single day or more than 14 drinks per week.

          6. Currently taking fentanyl or methadone

          7. Exhibiting the following contraindicated conditions: (1) significant respiratory
             depression (2) acute or severe bronchial asthma in an unmonitored setting or in the
             absence of resuscitative equipment (3) known or suspected gastrointestinal
             obstruction, including paralytic ileus (4) hypersensitivity (e.g. anaphylaxis) to
             oxycodone (5) patients with chronic pulmonary disease (6) elderly, cachet, or
             debilitated patients (7) patients with evidence of increased intracranial pressure,
             brain tumors, head injury, or impaired consciousness (8) patients with seizure
             disorders (9) pregnant and breastfeeding women, due to risks to the fetus/baby