Clinical trial NCT03588806: Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
Official title: Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Pain
Opioid Use
Deglutition
Keywords: Abuse-deterrent opioid drugs
Xtampza ER
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Collegium Pharmaceutical, Inc.
First posted: 2018-07-17
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: An important step in the evolution of pain care is more personalized medicine. One aspect of personalized medicine emphasizes that patients often have additional requirements for prescription medicines beyond just pain relief, including ease in taking medications and overall satisfaction with their care. Surveys indicate that 20% of adult patients either with or without pain have difficulty swallowing their medications, and up to 10% refuse to take a specific therapy because they cannot swallow the pills \[1-3\]. It is likely that this issue compromises the quantity, quality, and satisfaction with pain relief from oral opioids.

Xtampza ER is an opioid analgesic consisting of a microsphere-containing capsule that can be opened so the microspheres can be added to soft food. This drug is designed to overcome capsule-swallowing issues and therefore may be an important tool for personalized pain medicine care. This study will investigate the pharmaceutic delivery properties of Xtampza to determine whether it is an improved alternative to the pill-swallowing problems that are common with opioid drugs.

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

Primary outcomes:
measure: Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours
timeFrame: Measured at baseline and at the end of the 6-week study
measure: Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days
timeFrame: Measured at baseline and at the end of the 6-week study
Secondary outcomes:
measure: Change in Pill Swallowing Difficulty Score
timeFrame: Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
timeFrame: Measured at baseline and at the end of the 6-week study
measure: Opioid Medication Satisfaction
timeFrame: Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER.
measure: PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance
timeFrame: Measured at baseline and at the end of the 6-week study
measure: PROMIS Physical Function
timeFrame: Measured at baseline and at the end of the 6-week study
measure: Patient Global Impression of Change (PGIC)
timeFrame: Recorded in week 6.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Pain Medicine at Centre Commons
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ajay D Wasan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wasan AD, Michna E, Edwards RR, Katz JN, Nedeljkovic SS, Dolman AJ, Janfaza D, Isaac Z, Jamison RN. Psychiatric Comorbidity Is Associated Prospectively with Diminished Opioid Analgesia and Increased Opioid Misuse in Patients with Chronic Low Back Pain. Anesthesiology. 2015 Oct;123(4):861-72. doi: 10.1097/ALN.0000000000000768.
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