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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
11
Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.
UPMC Pain Medicine at Centre Commons
Pittsburgh, Pennsylvania, United States
Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours
Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.
Time frame: Measured at baseline and at the end of the 6-week study
Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days
Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable." As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score.
Time frame: Measured at baseline and at the end of the 6-week study
Change in Pill Swallowing Difficulty Score
Pill swallowing difficulty will be measured via a 0-10 scale with 0 being "no trouble at all" and 10 being "the greatest difficulty possible." Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being "Not at all" and 5 being "Very much". Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6).
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Time frame: Measured at baseline and at the end of the 6-week study
Opioid Medication Satisfaction
Opioid medication satisfaction will be measured via a 0-10 scale with 0 being "not satisfied at all" and 10 being "completely satisfied." Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).
Time frame: 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.
PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance
The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being "Never" and 5 being "Always". Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study
PROMIS Physical Function
The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being "Without any difficulty" and 1 being "Unable to do". Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6).
Time frame: Measured at baseline and at the end of the 6-week study
Patient Global Impression of Change (PGIC)
The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6).
Time frame: Recorded in week 6.