Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills

• Status: Terminated
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajay Wasan, MD, Msc
• Collaborator: Collegium Pharmaceutical, Inc.
• Treatments: Analgesics, Opioid; Oxycodone

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