Clinical trial NCT03588806
Conditions: Chronic Pain Opioid Use Deglutition
Keywords: Abuse-deterrent opioid drugs Xtampza ER
Sponsor: Ajay Wasan, MD, Msc
Start date: 2018-05-01; Completion date: 2019-10-31
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.
Interventions: intervention 1: Xtampza ER (oxycodone)
Intervention descriptions: intervention 1: Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.

Protocol documents:
Prot_SAP_001.pdf: 
 
1
 
 
 
 
2018 
Use of Xtampza ER to 
overcome difficulties in 
swallowing opioid pills 
CLINICAL RESEARCH PROTOCOL 
DEPARTMENT OF ANESTHESIOLOGY 
UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE 
IRB PRO17040444 
APPROVED 11/10/2017 


 
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Table of Contents 
 
Study Information ................................................................................................................................................. 3 
Study Contacts ...................................................................................................................................................... 4 
Subjects .................................................................................................................................................................. 4 
Eligibility ............................................................................................................................................................................ 5 
Subject Groups/Treatment Arms .................................................................................................................................... 6 
Treatment Arm 1: Open Label ........................................................................................................................................ 6 
Study Schedule ...................................................................................................................................................... 7 
Overview of Schedule ........................................................................................................................................................ 7 
Recruitment and Screening .............................................................................................................................................. 7 
Compensation Schedule .................................................................................................................................................... 8 
Detailed Study Schedule with Checklists ........................................................................................................................ 9 
Clinic Visit 1 ................................................................................................................................................................... 9 
Clinic Visit 2 ................................................................................................................................................................... 9 
Clinic Visit 3 ................................................................................................................................................................... 9 
Clinic Visit 4 (End of Study) ........................................................................................................................................ 10 
Daily Texts .................................................................................................................................................................... 10 
Weekly Surveys ............................................................................................................................................................ 10 
Study Measures ................................................................................................................................................... 12 
Medical History ............................................................................................................................................................. 12 
Medication Diary .......................................................................................................................................................... 12 
Medication Satisfaction Questions ................................................................................................................................ 12 
Modified Baylor Dysphagia Questionnaire .................................................................................................................. 12 
Pain Diary...................................................................................................................................................................... 13 
Pill Swallowing Difficulty Questions ........................................................................................................................... 13 
PROMIS-29 Adult Profile v2.0 (Participant Version) .................................................................................................. 13 
Text Message Compliance ............................................................................................................................................ 14 
Urine Pregnancy Test .................................................................................................................................................... 14 
Weekly Survey .............................................................................................................................................................. 14 
Text Message Scripts .......................................................................................................................................... 15 
Statistical Analysis Plan ..................................................................................................................................... 16 
Outcomes to be Analyzed ................................................................................................................................................ 16 
Primary Outcome 
 Pain Intensity........................................................................................................................... 16 
Overview of Analysis Plan .............................................................................................................................................. 17 
Data Management ............................................................................................................................................... 17 
Scripts and Files Needed ................................................................................................................................................. 17 
Updating Data Files ......................................................................................................................................................... 17 
Mosio SMS Text Messaging System .................................................................................................................. 19 
Initial Set-up (at Clinic Visit 1) ...................................................................................................................................... 19 
Scheduling Appointment Reminders ............................................................................................................................. 20 
Study Medication ................................................................................................................................................ 18 
Prescribing Xtampza ER ................................................................................................................................................ 22 
 
 
 
 
 
 
 


 
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Study Information 
 
Principle  
Investigator:  
Ajay Wasan, MD, MSc 
 
Study Coordinators: Andrea G. Gillman, PhD 
 
Institution: 
 
University of Pittsburgh School of Medicine 
 
 
 
 
Department of Anesthesiology 
 
IRB Protocol: 
University of Pittsburgh PRO17040444 
 
 
 
Approved: 11/10/2017 
 
 
 
Expiration Date:  10/24/2018  
 
Study Location: 
UPMC Pain Medicine Clinic at Centre Commons 
 
 
 
5750 Centre Ave, Ste. 400 
 
 
 
Pittsburgh, PA 15206  
 
Sponsoring Agency: Collegium Pharmaceutical, Inc. 
 
780 Dedham Street, Suite 800 
 
Canton, MA 02021 
 
Study Objective: 
Xtampza ER is an oral opioid medication capsule that can be opened to allow the pellets 
to be added to food or drink. This study will investigate whether Xtampza ER can 
adequately address common quality of care deficits of opioid medications. 
 
Specific Aims: 
We hypothesize that the subjects in our study will report comparable pain relief and 
improved ability to take opioid medication through the dispersal of the microspheres in 
food or liquid. 
1. The primary hypothesis is that there will be a significant improvement in ratings of 
swallowing difficulties in comparing pre- vs. post-administration scores. 
2. The secondary hypothesis is that there will be a non-inferior difference between pre- 
and post-pain ratings. In other words, after being converted to Xtampza ER, there will be 
no reported meaningful differences in the degree of pain. 
 
 


 
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Study Contacts 
 
Principle Investigator 
Ajay D. Wasan, MD, MSc 
 
 
 
 
Dept. of Anesthesiology, University of Pittsburgh School of Medicine 
 
 
 
 
UPMC Pain Medicine 
 
 
 
 
(412) 665-8048 
 
 
 
 
wasanad@upmc.edu 
 
 
Study Coordinators  
Andrea G. Gillman, PhD 
 
 
 
 
Dept. of Anesthesiology, University of Pittsburgh School of Medicine 
 
 
 
 
(412) 665-2904 
 
 
 
 
gillmana@pitt.edu 
 
  
Sponsoring Agency  
Michael DeGeorge, PharmD 
 
 
VP, Medical Affairs 
 
 
Collegium Pharmaceutical, Inc. 
 
 
(631) 431-4507 
 
 
mdegeorge@collegiumpharma.com 
 
 
Danielle Ruch, MBA 
Manager, Medical Operations 
Collegium Pharmaceutical, Inc. 
(781) 232-0770 
druch@collegiumpharma.com 
 
Pharmacy 
Howard Brenner 
Avella of Orlando, Inc. 
100 Technology Park, Suite 1525 
Lake Mary, FL 32746 
Phone: (407) 792-7099 
Fax: (877) 430-4768 
howard.brenner@avella.com  
 
 
Text Messaging 
 
Noel Chandler, CEO 
Mosio Simple Support 
noel@mosio.com 
 
 
 
 
 
 
 
 
 
 
Charlotte Justice, Account Manager 
 
 
 
 
Mosio Simple Support 
 
 
 
 
charlotte@mosio.com  
 
 
 
 
 
 
 
 
 
 
Jay Sachdev, Software Developer 
 
 
 
 
Mosio Simple Support 
 
 
 
 
 
jay@mosio.com 
 
 
Subjects 
 


 
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Eligibility 
 
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 our 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 
detemrined 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, COPD 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. Demonstartion 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 contradidated 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  
 
 
 
 


 
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Subject Groups/Treatment Arms 
 
Treatment Arm 1: Open Label 
 
Target Enrollment: 20  
 
Description: 
Subjects will be prescribed Xtampza ER for the duration of the study. Dosage and side 
effects will be monitored by the PI.  
 
Treatment Protocol: Administration of Xtampza ER will begin at Clinic Visit 2 in Week 2 of the study. 
During this clinic visit, subjects will discuss with the investigator conversion of their 
current opioids to Xtampza ER. If subjects are on a mix of short and long acting opioids, 
they may elect to only convert the long-acting opioid if this is the medication giving them 
the swallowing difficulties. In other words, ideally we would convert both the long and 
short acting opioids to Xtampza ER. However, we realize that subjects may prefer to still 
have their current breakthrough medication, which may not be giving them swallowing 
difficulties, and thus the accommodation of only converting the long-acting opioids. We 
will use a standard conversion table to calculate the dose. But, due to the phenomenon of 
incomplete cross tolerance, we will only convert 75% of the calculated dose to Xtampza 
ER. Subjects are dispensed a 7-10 day supply of Xtampza ER at the end of the visit. As 
per manufacturer recommendations, subjects will be instructed to take each dose of 
Xtampza ER with the same amount of food. Subjects will be instructed to open the 
capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and 
then consume the food.  
 
 
 
 


 
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Study Schedule 
 
Overview of Schedule 
 
Week 0: 
 
Recruitment & Screening 
Week 1: 
 
Clinic Visit 1, Daily text messaging begins 
Week 2: 
 
Clinic Visit 2 
Week 3: 
 
Clinic Visit 3 
Week 4: 
 
Weekly Survey – Week 4 
Week 5: 
 
Weekly Survey – Week 5 
Week 6: 
End of Study. Clinic Visit 4, Daily text messaging ends 
 
Recruitment and Screening 
 
Recruitment: 
Patients will be recruited from the UPMC Pain Medicine Clinic at Centre Commons from 
the PI and clinic providers approaching their patients. Clinic providers include Drs. 
Wasan (the study PI), Ed Heres, Cheryl Bernstein, Trent Emerick, and Susan Jarquin. If a 
physician is aware of a potential participant, the physician will briefly inform the 
participant of the research study and ask the participant for permission to be approached 
or called by the research team and, if permission is given, this will be documented by the 
physician. 
 
Flyers will be posted in the clinic waiting rooms and exam rooms with instructions to 
call, email or text the study coordinators to indicate interest in their study. The research 
team will then contact the interested volunteer to perform the initial screening. 
 
We are also planning to use the University of Pittsburgh Pitt+Me Registry as a recruiting 
tool.  
 
Efforts will be made to attain a mix of study participants, in terms of gender and 
racial/ethnic representation reflective of the population of the greater metropolitan 
Pittsburgh area. According to the 2010 census, this distribution should be: 52% female, 
48% male, 66% White, 26% Black or African American, 4% Asian, 2% Hispanic or 
Latino, 2% Two or More Races. 
 
We will review our patient demographic distribution quarterly and if we find that our 
gender or minority recruitment is lagging we will initiate targeted recruitment strategies 
to increase gender or minority representation. For example, if minority recruitment is 
lagging, we may post flyers at other UPMC Pain Medicine clinics such as Montefiore and 
Mercy Hospital. 
 
Advertisements: 
110536A PAIN & SWALLOWING STUDY POSTER final.pdf 
 
Screening: 
 
Use the study’s Phone Screening Form. Enter data into the form during phone interview. 
 
 
 
 
File name: Wk0.PhoneScreeningForm.docx  
 
Post- 
Screening Tasks: 
 Confirm eligibility with Dr. Wasan 


 
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 Contact volunteer about eligibility status 
 If eligible, schedule Clinic Visit 1 
 
 
Compensation Schedule 
 
Full Study Participation: 
 
1. Clinic Visit 1: $20  
 
 
 
 
 
2. Clinic Visit 4: $100 
 
Partial Study Participation:  
1. Clinic Visit 1: $20  
 
 
 
 
 
2. If at least half of study activities are completed: $30 
 
Travel Reimbursement: 
 
Up to $25 for travel to and from Centre Commons. 
 
 


 
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Detailed Study Schedule with Checklists 
 
Clinic Visit 1 
 
Scheduled: 
 
Week 1  
Location: 
 
UPMC Pain Medicine Clinic at Centre Commons, Suite 400 
Appt. Reminder: 
 Research staff should call to confirm 24 hrs before appointment 
 
Preparation Tasks: 
 Print/gather paper forms: 
 
 
 
 
 Informed Consent:  Wk1.1.ConsentForm.docx  
 Medical History:  Wk1.2.MedicalHistoryForm.docx 
 
 
 
 Set up Chromebook for REDCap data entry 
 
Visit Tasks:  
 PI – Obtain informed consent. Complete Medical History 
 
 
 
 Staff – Enrollment Information (REDCap) 
 Subject completes REDCap surveys: PROMIS-29 & Opioid Medication Satisfaction 
 
 
 
 Staff – Set up subject in Mosio text messaging system & WePay system.  
 Staff – Schedule Clinic Visit 2 
 
Tasks After Appt.:  
 Order Xtampza ER from pharmacy 
 
 
 
 Schedule appointment reminders for Clinic Visit 2 in Mosio text message system 
 Pay subject for clinic visit in WePay - $20 for Clinic Visit 1 & reimburse for  
    transportation/parking 
 
Clinic Visit 2 
 
Scheduled: 
 
Week 2 
Location: 
 
UPMC Pain Medicine Clinic at Centre Commons, Suite 400 
Appt. Reminder: 
Programmed into Mosio SMS schedule. Text Name: APPT_CLIN 
 
Preparation Tasks: 
 Set up Chromebook for REDCap data entry 
 
 
 
 Confirm study medication shipment with pharmacy 
 
Visit Tasks:  
 Physician – Xtampza ER administration instructions 
 Subject completes REDCap surveys:  
1. Modified Baylor Dysphagia Questionnaire 
2. PROMIS-29 
3. Pill Swallowing Difficulty Questions 
 Staff – Schedule Clinic Visits 3 & 4 (in weeks 3 & 6).  
 Staff – Reimburse subjects for transportation/parking in WePay 
 
Tasks After Appt.:  
 Schedule appointment reminders for Clinic Visits 3 & 4 in Mosio text message system 
 
 
Clinic Visit 3 
 
Scheduled: 
 
Week 3 
Location: 
 
UPMC Pain Medicine Clinic at Centre Commons, Suite 400 
Appt. Reminder: 
Programmed into Mosio SMS schedule. Text Name: APPT_CLIN 
 
Preparation Tasks: 
 Set up Chromebook for REDCap data entry 


 
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Visit Tasks:  
 Physician – monitor side effects & dosage 
 Subject completes REDCap surveys:  
1. Modified Baylor Dysphagia Questionnaire 
2. PROMIS-29 
3. Pill Swallowing Difficulty Questions 
4. Xtampza ER Satisfaction Question 
 Staff – Reimburse subjects for transportation/parking in WePay 
 
 
Clinic Visit 4 (End of Study) 
 
Scheduled: 
 
Week 6 
Location: 
 
UPMC Pain Medicine Clinic at Centre Commons, Suite 400 
Appt. Reminder: 
Programmed into Mosio SMS schedule. Text Name: APPT_CLIN 
 
Preparation Tasks: 
 Set up Chromebook for REDCap data entry 
 
Visit Tasks:  
 Physician – discuss options for future medication/dosage 
 Subject completes REDCap surveys:  
1. Modified Baylor Dysphagia Questionnaire 
2. PROMIS-29 
3. Pill Swallowing Difficulty Question 
4. Xtampza ER Satisfaction Question 
5. Patient Global Impression of Change 
 Staff – Turn off Mosio text messaging for subject 
 Staff – Pay subject $100 in WePay for study completion and reimburse for 
transportation/parking  
 
Tasks After Appt.:  
 Download final subject data from REDCap and Mosio 
 
 
Daily Texts 
 
Scheduled: 
 
Every day starting with Clinic Visit 1 – Weeks 1-6 
Collection Route: 
Mosio text message 
 
 
 
Text name: PAIN_DIARY, MED_DIARY 
 
Measures Taken: 
Pain Diary Questions 
 
 
 
Medication Diary Questions  
 
Researcher Tasks: 
 Check and download Mosio study data once each week 
 
 
Weekly Surveys 
 
Scheduled: 
 
Weeks 4 & 5 
Collection Route: 
REDCap survey. Survey link sent via Mosio text message. Text name: SURVEY_LINK 
 
Measures Taken: 
Pill Swallowing Difficulty Question 


 
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PROMIS-29 
 
 
 
Xtampza ER Satisfaction Question (Week 5 only) 
 
 
 
Patient Global Impression of Change (Week 5 only) 
 
Researcher Tasks: 
 Check and download REDCap study data once each week 
 
 


 
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Study Measures 
 
Medical History 
Description 
Short form to collect subject’s demographic information, medical and psychiatric history.  
 
Data Entry by 
Study Physician 
 
Data  
Collection Route 
Paper 
 
Equipment/Supplies Wk1.2.MedicalHistoryForm.docx 
 
Medication Diary 
Description 
One daily question to monitor Xtampza ER use and compliance.   
 
 
Data Entry by 
Subjects 
 
Data  
Collection Route 
Mosio SMS 
 
Data Collected 
Q1: Did you remember to take your study medication yesterday? Text Y or N. 
 
Medication Satisfaction Questions 
Description 
Brief questions to determine the subject’s satisfaction with their current opioid pain 
medication.  
 
 
 
Data Entry by 
Subjects 
 
Data  
Collection Route 
REDCap 
 
Data Collected 
Week 1 – Opioid Medication Satisfaction Question:  
How satisfied are you with your current opioid medication?  
0------------------------10 
 
 
 
 
 
Not satisfied at all 
Completely satisfied 
 
 
 
 
Weeks 3, 5 & 6 – Xtampza ER Satisfaction Question: 
 
 
 
 
How satisfied are you with the study medication, Xtampza ER? 
0------------------------10 
 
 
 
 
 
Not satisfied at all 
Completely satisfied 
 
Modified Baylor Dysphagia Questionnaire 
Description 
Swallowing difficulty questionnaire used at Baylor Medical Centers (questions 1-11) 
 
 
Data Entry by 
Subjects  
 
Data  
Collection Route 
REDCap  
 
Data Collected 
1. Complaints regarding swallowing 
 
 
 
2. Date of onset of swallowing problems 
 
 
 
3. Swallowing problems currently experienced 
 
 
 
4. Food intake information   
 
 


 
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Original  
Documentation 
https://www.baylorhealth.com/ 
 
Pain Diary 
Description 
Two daily questions about the subject’s pain; questions #5 and 6 from the Brief Pain 
Inventory.  
 
Data Entry by 
Subjects 
 
Data  
Collection Route 
Mosio SMS texts 
 
Data Collected 
Q1: What is your level of pain now? Text 0-10. 0 = no pain, 10 = pain as bad as you can 
imagine. 
 
Q2: What was your average level of pain over the last 24 hours? Text 0-10. 0 = no pain, 
10 = pain as bad as you can imagine. 
 
Pill Swallowing Difficulty Questions 
Description 
Brief question to determine current level of swallowing difficulty  
 
Data Entry by 
Subjects  
 
Data  
Collection Route 
REDCap  
 
Data Collected 
Week 1: Do you have difficulty swallowing medications?  
If yes, how would you rate the difficulty swallowing your current opioid pain 
medications?   
0------------------------10 
 
 
 
 
 
No trouble at all 
The greatest difficulty possible 
 
Weeks 2-6: How would you rate the difficulty swallowing this study pain medication?  
0------------------------10 
 
 
 
 
 
No trouble at all 
The greatest difficulty possible 
 
PROMIS-29 Adult Profile v2.0 (Participant Version) 
Description 
Adult Profile 29-item instrument that contains a fixed collection of short forms measuring 
several physical and emotional domains.  
 
 
 
Data Entry by 
Subjects 
 
Data  
Collection Route 
REDCap 
 
Data Collected 
Physical Function Score = sum of q1 - q4 (range 4-20) 
 
 
 
Anxiety Score = sum of q5 - q8 (range 4-20) 
 
 
 
Depression Score = sum of q9 - q12 (range 4-20) 
 
 
 
Fatigue Score = sum of q13 - q16 (range 4-20) 
 
 
 
Sleep Disturbance Score = sum of q17 - q20 (range 4-20) 
 
 
 
Social Roles Score = sum of q21 – q24 (range 4-20) 
 
 
 
Pain Interference Score = sum of q25 – q28 (range 4-20) 
 
 
 
Pain Intensity Score = answer to q29 (range 0-10) 
 
 
 
See PROMIS Profile Scoring Manual for more information. 


 
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Original  
Documentation 
https://www.assessmentcenter.net  
 
 
References 
Cella, D., et al. (2010). "The Patient-Reported Outcomes Measurement Information 
System (PROMIS) developed and tested its first wave of adult self-reported health 
outcome item banks: 2005-2008." J Clin Epidemiol 63(11): 1179-1194. 
 
Text Message Compliance 
Description 
Record of whether and when subjects answered text message questions.   
 
 
Data  
Collection Route 
Mosio SMS 
 
Data Collected 
Answer received (y/n), time of receipt 
 
 
Urine Pregnancy Test 
Description 
“Dipstick” test for pregnancy in female subjects of child-bearing age 
 
Data  
Collection Route 
Urine Pregnancy Tests 
 
How to Administer Administer during the collection for the urine toxicology test listed above. Place dipstick 
in specimen cup and check for results before sealing cup for shipment pick-up. 
 
Weekly Survey 
Description 
Weekly survey; includes pain, psychological evaluations & swallowing difficulty  
 
 
Data Entry by 
Subjects  
 
Data  
Collection Route 
REDCap (link send via Mosio SMS) 
 
Data Collected 
Pill Swallowing Difficulty Question 
PROMIS-29 – full survey 
 
 


 
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Text Message Scripts 
 
TEST 
Text Contents 
<Welcome to the research study! Did you receive this message? Text Y or N> 
 
 
Allowed Answer Types 
Yes or No 
 
Branching 
 
 
If Y, text <Thank you!> 
 
Compliance Data 
 
Time sent, Time received, Did subject respond 
 
APPT_CLIN 
Text Contents 
<You have a research appointment at UPMC Pain Medicine at Centre Commons  
 
tomorrow, [DATE], at [TIME]. Text Y to confirm or N to cancel.>  
 
Allowed Answer Types 
Yes or No 
 
Branching 
 
 
If Y, text <Thank you. See you tomorrow!> 
 
 
 
 
If N, text <OK. A researcher will be in touch shortly to re-schedule your  
appointment.> 
 
Notes  
 
 
Mosio will notify research coordinator of subject cancellation 
 
PAIN_DIARY 
Question 1 
Text Contents 
<What is your level of pain now? Text 0-10. 0 = no pain, 10 = pain as bad as you  
 
can imagine.> 
 
Allowed Answer Types 
Numeric: 0-10 scale 
 
Compliance Data 
 
Time sent, Time responded, Did subject respond 
 
Question 2 
Text Contents 
<What was your average level of pain over the last 24 hours? Text 0-10. 0 = no  
 
pain, 10 = pain as bad as you can imagine.> 
Allowed Answer Types 
Numeric: 0-10 scale 
 
Compliance Data 
 
Time sent, Time responded, Did subject respond 
 
MED_DIARY 
Text Contents 
<Did you remember to take your study medication yesterday? Text Y or N.> 
 
Allowed Answer Types 
Yes or No 
 
Branching 
 
 
If Y, text <Thank you.> 
 
 
 
 
If N, text <Remember to take all of your prescribed medication. This is an  
important part of your treatment.> 
 
Compliance Data 
 
Time sent, Time responded, Did subject respond 
 


 
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Statistical Analysis Plan 
 
Outcomes to be Analyzed 
 
Primary Outcome 
 
Pain Intensity 
• Weekly average pain: PROMIS-29 Pain Intensity 
• Daily average pain: Text Message Pain Diary Questions 
 
 
 
 
 
  
Secondary Outcomes 
Swallowing Satisfaction 
• Pill Swallowing Difficulty Questions 
 
Pain Interference 
• PROMIS-29 Pain Interference 
 
Medication Satisfaction 
• Opioid Medication Satisfaction Question 
• Xtampza ER Satisfaction Question 
 
Swallowing Difficulty  
• Modified Baylor Dysphagia Questionnaire 
 
Mental Health Outcomes 
• PROMIS-29 Depression 
• PROMIS-29 Anxiety 
• PROMIS-29 Satisfaction with Social Roles 
• PROMIS-29 Sleep Disturbance 
• PROMIS-29 Fatigue 
 
Physical Health Outcomes 
• PROMIS-29 Physical Function 
 
Impression of Change 
• Patient Global Impression of Change 
 
 
 
 


 
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Overview of Analysis Plan 
 
The primary outcome of changes in pain is calculated by comparing average pain level at baseline to the 
average of the last four weeks of treatment (i.e., after the two week conversion period). This is a comparison of 
the average of the seven days of average pain ratings between weeks 1 and 2 to the average of the weekly 
average pain intensity ratings collected on the PROMIS-29 questionnaires (pre vs. post). The comparisons of 
pre vs post will be done with an analysis of covariance (ANCOVA), which permits inclusion of relevant 
covariates, such as the baseline level of pain. The primary hypothesis is that there will be a non-inferior 
difference between pre-and post-pain ratings. In other words, after being converted to Xtampza ER, there will 
be no reported meaningful differences in the degree of pain. 
 
The main secondary outcome is change in swallowing difficulty of opioid medication. The Pre vs Post 
comparisons are calculated in a similar fashion to the primary pain outcome, and compared using ANCOVA. 
This is a comparison between the baseline ratings of swallowing difficulties versus the average of these ratings 
in the last four weeks of study. The secondary hypothesis is that there will be a significant improvement in 
ratings of swallowing difficulties in comparing pre- vs. post scores.  
 
The same statistical approach is taken for the other secondary outcomes, such as global impression of change, 
satisfaction with pain care, and side effects. We anticipate that subjects will report on average greater 
satisfaction with pain care, ‘improved’ or ‘much improved’ global impression of change, and comparable side 
effects. For any outcome, in the event of greater than 20% missing data, we will first determine if this data is 
missing at random. If it does appear that this is the case then we will analyze that outcome with mixed linear 
modeling, which produces more reliable estimates of effect sizes with such missing data. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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Study Medication 
 
Instructions for Prescribing Xtampza ER (from Collegium & Avella) 
 
• Avella will provide your site with pre-paid UPS envelopes. 
• Your site will place the patient enrollment form (Wk1.3.PharmacyEnrollmentForm.docx) in the pre-paid 
envelope and send it to Avella.  
• The PI will prescribe the study drug via EPIC using Avella Orlando as the pharmacy. 
• Avella will contact the PI to confirm the prescription dosage and instructions prior to dispensing 
• Please inform your subjects that they will receive a telephone call from Avella to complete a 5-
minute consultation prior to dispensing the study drug.  This consultation is important to ensure that 
the subject takes the medication as prescribed and that Avella will address any questions that the subject 
may have. This consultation is required for all subjects.  
• After Avella confirms the prescription with the PI and completes a 5-minute consultation with the 
subject, then Avella will dispense the study drug to the subject.  
• Avella also requested that we remind your site that they are located on the East coast, which is Eastern 
Standard Time (EST). 
 
 

ICF_000.pdf: 
University of Pittsburgh 
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CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY 
 
TITLE: Use of Xtampza ER to overcome difficulties in swallowing opioid pills 
PRINCIPAL INVESTIGATOR: 
Ajay Wasan, MD, MSc 
Professor and Vice Chair of Pain Medicine 
University of Pittsburgh Physicians 
Department of Anesthesiology & Psychiatry 
5750 Centre Ave., Suite 400 
Pittsburgh, PA 15206 
Telephone: (412) 665-8048
SOURCE OF SUPPORT: 
Collegium Pharmaceuticals 
About this consent form 
Please read this form carefully. It tells you important information about a research study. A 
member of our research team will also talk to you about taking part in this research study. People 
who agree to take part in research studies are called “subjects.” This term will be used 
throughout this consent form. If you choose to take part in this study, we will ask you to sign this 
consent form before we do any study procedures. 
Why is this research study being done? 
We are doing this research study to determine if the ability to open up the Xtampza ER capsules 
and put the pellets in food or drink will make it easier to swallow opioid pain medications. 
 
Who is being asked to take part in this research study? 
We will ask adult individuals who have been prescribed opioid medications for chronic pain and 
who have trouble swallowing these pills to participate in this study. You are expected to have 
access to a mobile phone that can send and receive text messages and access the internet.  
 
Your physician may be the investigator in this research study. Before agreeing to participate, or 
at any time during your study participation, you may discuss your care with another doctor who 
is not associated with the research study. You are not under any obligation to participate in any 
research study offered by your physician. 
 
How long will I take part in this research study? 
It will take you 6 weeks to complete this research study. Everyone who participates in this study 
will attend 4 study visits at the UPMC Pain Medicine Clinic at Centre Commons. These visits 
will be approximately 1-2 hours long. 
 
What will happen in this research study? 
  
Study Visit 1 (Week 1) 
The Screening Visit will take about 2 hours at the UPMC Pain Medicine Clinic at Centre 
Commons. At this visit, we will: 


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• Ask about your medical history and review your medical records 
• Give you a urine pregnancy test if you are a woman of child-bearing age. Pregnant 
women cannot take part in this research study. 
• Give you some online questionnaires to fill out about your general health and well-being, 
quality of life, pain, and how much trouble you have swallowing pills. 
• Check that your mobile phone can receive the daily text messages for the study. 
Text Messages 
• After Study Visit 1, you will receive daily text messages to track your pain and 
medication use. These texts will ask you to respond to simple questions. For example, 
you will receive a text that says “What is your level of pain now? Text 0-10. 0 = no pain, 
10 = pain as bad as you can imagine.” You would then text the number that corresponds 
to your current pain, such as “5” if you are experiencing moderate pain. 
• These messages will count towards your text and data usage on your mobile phone plan. 
Please contact your mobile phone carrier for more information.  
Study Visit 2 (Week 2) 
Visit 2 will take about 1.5 hours at the UPMC Pain Medicine Clinic at Centre Commons. At this 
visit, we will:  
• Give you some online questionnaires to fill out 
• Begin the conversion of your current opioid medications to Xtampza ER. 
You will take the study drug by mouth for the entire study. Every time you take Xtampza ER, 
you will open the capsule, sprinkle the drug microspheres onto soft food such as applesauce or 
pudding, and then eat the food with the microspheres. You will need to take the drug with the 
same amount of food every time. It is important for you to follow our instructions about how to 
take the study drug. Bring any unused study drug with you to your next study visit. 
Visit 3 (Week 3) 
Visit 3 will take about 1 hour at the UPMC Pain Medicine Clinic at Centre Commons. At this 
visit we will: 
• Ask you questions about side effects or health problems since your last visit  
• Give you some online questionnaires to fill out 
• Refill your medication or change the Xtampza ER dose if appropriate 
After this visit, you will be emailed or texted a link to take a survey on a weekly basis. This is 
separate from the daily text messages you have been receiving. 
 
Visit 4 (Week 6) 
Visit 4 will take about 1 hour at UPMC Pain Medicine at Centre Commons. At this visit we will: 
• Ask you questions about side effects or health problems since your last visit  
• Give you some questionnaires to fill out 
• Return to your usual medication regimen and follow up with your pain physician. You 
can also discuss whether to switch over to Xtampza ER long-term. 


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What are the risks and possible discomforts from being in this research study? 
RISKS OF TAKING XTAMPZA ER: 
(1) Xtampza ER is Addictive 
Xtampza ER contains oxycodone, an opioid drug controlled by the United States Drug 
Enforcement Administration (DEA). Taking any opioid drug can lead to addiction, abuse, and/or 
misuse. There is no way to determine whether you will become addicted to, abuse, or misuse an 
opioid drug. You may develop an addiction to this drug even if you take it as directed by the 
researchers and/or your doctor.  
 
The specific risks related to addiction, abuse, and/or misuse of Xtampza ER are: 
1.
A risk of overdose and death. Xtampza ER is an extended-release product and carries a 
higher risk of overdose and death due to the larger amount of oxycodone present. 
Possible symptoms of an overdose are: 
1. Respiratory depression (slow breathing) 
2. Somnolence (sleepiness) progressing to stupor or coma 
3. Muscle weakness 
4. Cold and clammy skin 
5. Constricted (tiny) pupils or dilated pupils 
6. Pulmonary edema (fluid in the lungs)  
7. Bradycardia (slow heart beat) 
8. Low blood pressure 
9. Partial or complete airway obstruction 
10.Unusual snoring 
11.Death 
2.
Abuse or misuse of Xtampza ER by snorting or injecting the dissolved product can result 
in overdose and death.
3.
Someone may try to steal this drug from you.  
At each study visit, the study doctor will check whether you are showing any signs of addiction, 
abuse, or misuse by asking you questions and having you fill out forms. If you are showing signs 
of addiction, abuse, or misuse, you will be referred to an appropriate treatment program. 
 
(2) Xtampza ER Can Slow Down Breathing to Dangerous Levels 
Xtampza ER and other opioid drugs can slow down your breathing, a condition called 
“respiratory depression.” This can happen even if you take the drug as directed by the 
researchers and/or your doctor. 
1.
Respiratory depression caused by Xtampza ER and other opioid drugs can be fatal. 
2.
The highest risk of respiratory depression is during the first 3 days after you start taking 
Xtampza ER. 
 
(3) Xtampza ER is Dangerous to Newborn Babies 
It is not safe to take Xtampza ER or other opioid drugs while pregnant. Babies born to women 
who take opioid drugs will develop a condition called Neonatal Opioid Withdrawal Syndrome. 
This condition can be fatal to newborn babies. 
 


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Because of these risks, women cannot take part in this study if they are: 
1.
Pregnant 
2.
Trying to become pregnant  
3.
Breastfeeding 
If you are a menopausal woman and have not had a period for the past 12 months or more, you 
will not need to have a pregnancy test. Also, you will not need to have a pregnancy test if you 
have had a hysterectomy (surgical removal of your uterus and/or ovaries). All other female 
subjects must have a negative pregnancy test before starting the study drug. 
If you are sexually active and able to become pregnant, you must agree to use one of the birth 
control methods listed below. You must use birth control for the entire study. Acceptable birth 
control methods for use in this study are: 
1.
Hormonal methods (birth control pills, 
patches, injections, vaginal ring, or 
implants) 
2.
Barrier methods (condom or diaphragm) 
used with a  
3.
Spermicide (a foam, cream, or gel that 
kills sperm) 
4.
Intrauterine Device (IUD) 
5.
Abstinence (no sex) 
If you miss a period or think you might be pregnant during the study, you must tell the study 
doctor immediately. If you become pregnant, you must stop taking the study drug and stop 
taking part in the study. 
(4) Stopping Xtampza ER Too Quickly Can Lead to Withdrawal 
Stopping the use of Xtampza ER or other opioid drugs too quickly can lead to withdrawal 
syndrome. Some of the effects of withdrawal syndrome are: 
1.
Restlessness 
2.
Lacrimation (watery eyes) 
3.
Rhinorrhea (runny nose) 
4.
Yawning 
5.
Perspiration (sweating) 
6.
Chills 
7.
Myalgia (muscle pain) 
8.
Mydriasis (dilated pupils) 
9.
Irritability 
10.
Anxiety (nervousness) 
11.
Backache 
12.
Joint pain 
13.
Weakness 
14.
Abdominal cramps 
15.
Insomnia (trouble sleeping) 
16.
Nausea (upset stomach) 
17.
Anorexia (decreased appetite) 
18.
Vomiting 
19.
Diarrhea 
20.
Increased blood pressure 
21.
Increased heart beat 
22.
Faster breathing 
It is important to follow the doctor’s directions for discontinuing Xtampza ER in order to prevent 
these side effects. 
 
(5) It is Dangerous to Drive or Operate Machinery While Taking Xtampza ER 
Taking Xtampza ER can impair your ability to think and to drive a car or operate heavy 
machinery. We advise that in switching to Xtampza that you should not drive or operate other 
heavy machinery until you are used to the medication and feel confident that you are safe to 
drive. 
(6) Xtampza ER Can Have Dangerous Interactions with Alcohol and Other Drugs 
Taking Xtampza ER with some types of medications or with alcohol may have harmful effects. 


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There are certain medications that interact with the breaking down of oxycodone in the body. 
Oxycodone is the active ingredient in Xtampza used in this study. If you are on one of these 
medications, we will let you know because you might be at risk of developing too high or too 
low of a level of oxycodone in your bloodstream.  We will also take this issue into account when 
prescribing the dose of Xtampza. Notify Dr. Wasan if you are taking any of the following types 
of medications: 
1.
Drugs that inhibit the Cytochrome P450 3A4 enzyme may cause potentially fatal 
respiratory depression when taken with Xtampza ER or other opioid drugs. These drugs 
include some antibiotics (erythromycin), antifungal agents (ketoconazole), and protease 
inhibitors (ritonavir). 
2.
If you are taking a drug that induces the Cytochrome P450 3A4 enzyme while taking 
Xtampza ER or other opioid drugs, you may experience withdrawal symptoms if you stop 
taking the Cytochrome P450 3A4 inducing drug. These drugs include rifampin, 
carbamazepine, and phenytoin. 
3.
Drugs or substances that depress the central nervous system (CNS) can cause severe 
sedation, respiratory depression, coma, and death when taken with Xtampza ER or other 
opioid drugs. These drugs and substances include alcohol, benzodiazepines, 
sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, 
antipsychotics, and other opioid drugs. 
4.
Drugs that affect the neurotransmitter serotonin can cause serotonin syndrome when 
taken with Xtampza ER or other opioid drugs. Drugs that affect serotonin include 
selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine 
reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 
receptor antagonists, mirtazapine, trazodone, tramadol, and monoamine oxidase 
inhibitors (MAOIs). Serotonin syndrome is a potentially fatal condition, and its 
symptoms include: 
1.
Confusion 
2.
Agitation or restlessness 
3.
Dilated pupils 
4.
Headache 
5.
Changes in blood pressure 
6.
Changes in body temperature 
7.
Nausea and/or vomiting 
8.
Diarrhea 
9.
Rapid heart rate 
10.
Tremor 
11.
Loss of muscle coordination or twitching 
muscles 
12.
Shivering and goose bumps 
13.
Heavy sweating 
1.
Xtampza ER and other opioids drugs can reduce the effects of diuretic drugs that 
increase urination. 
2.
Taking anticholinergic drugs with Xtampza ER or other opioids may increase the risk of 
urinary retention and constipation. Examples of anticholinergic drugs include 
hyoscyamine and atropine. 
(7) Xtampza ER May Be Especially Dangerous If You Have One of These Conditions 
People with certain conditions are especially vulnerable to harmful effects of Xtampza ER and 
other opioid drugs. 
1.
There is a higher risk of severe or life-threatening respiratory depression in people with 
chronic pulmonary disease and in elderly, cachectic, or debilitated persons. 
2.
Patients with increased intracranial (inside the head) pressure, brain tumors, head 
injury, or impaired consciousness who take Xtampza ER or other opioid drugs are at 
risk for reduced breathing and increased carbon dioxide retention. 


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3.
Xtampza ER and other opioid drugs may cause spasm of the sphincter of Oddi and 
increases in the serum amylase in patients with gastrointestingal obstruction, including 
paralytic ileus. 
4.
Xtampza ER and other opioid drugs may increase the frequency of seizures in patients 
with seizure disorders, including epilepsy. 
 
(8) Xtampza ER May Cause Adrenal Insufficiency 
Prolonged use of Xtampza ER and other opioid drugs may cause adrenal insufficiency, a 
condition characterized by the following symptoms: 
1.
Nausea
2.
Vomiting 
3.
Anorexia 
4.
Fatigue
5.
Weakness 
6.
Dizziness 
7.
Low blood pressure
(9) Xtampza ER May Cause Severe Low Blood Pressure 
Xtampza ER and other opioid drugs may cause severe low blood pressure, especially in people 
with reduced blood volume or who are taking certain CNS depressant drugs such as 
phenothiazines or general anesthetics. 
 
POSSIBLE DISCOMFORTS FROM TAKING XTAMPZA ER: 
 
The most common side effects of Xtampza ER reported in clinical trials are: 
1.
Nausea (upset stomach) -16.6% 
2.
Headache - 13.9% 
3.
Constipation – 13.0%  
4.
Somnolence (sleepiness) – 8.8% 
5.
Pruritus (itching) – 7.4% 
6.
Vomiting – 6.4% 
7.
Dizziness – 5.7% 
 
Less common side effects of Xtampza ER reported in 1 - 5% of patients in clinical trials 
are:  
8.
Blurred vision 
9.
Abdominal pain 
10.
Upper abdominal pain 
11.
Diarrhea 
12.
Gastroesophageal reflux disease 
13.
Chills 
14.
Drug withdrawal syndrome 
15.
Fatigue (tiredness) 
16.
Irritability 
17.
Edema (fluid build-up) 
18.
Pyrexia (fever) 
19.
Excoriation (scratches on the skin) 
20.
Decreased appetite 
21.
Hyperglycemia (high blood sugar) 
22.
Arthralgia (joint pain) 
23.
Back pain 
24.
Musculoskeletal pain 
25.
Myalgia (muscle pain) 
26.
Migraine (severe headache) 
27.
Tremor (shaking) 
28.
Anxiety (nervousness) 
29.
Insomnia (sleeplessness) 
30.
Withdrawal syndrome 
31.
Cough 
32.
Oropharyngeal pain (sore throat) 
33.
Hyperhidrosis (excessive sweating) 
34.
Rash 
35.
Hot flush 
36.
Hypertension (high blood pressure) 
Uncommon side effects of Xtampza ER reported in less than 1% of patients in clinical 
trials are:  


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37.
Increased gamma-glutamyl transferase (a 
liver enzyme) 
38.
Increased heart rate 
39.
Lethargy (lowered consciousness) 
40.
Memory impairment (trouble remembering 
things) 
41.
Poor-quality sleep 
42.
Abnormal dreams 
43.
Euphoric mood (feeling of well-being) 
44.
Restlessness 
45.
Dyspnea (shortness of breath) 
46.
Night sweats 
Risks of Questionnaires 
We will ask you to fill out a set of questionnaires about your pain and mental health. If you feel 
uncomfortable about answering a question, you can choose not to answer it. Dr. Ajay Wasan, a 
psychiatrist and pain physician as well as the study investigator, will be available to answer any 
questions you may have. 
Risks of Breach of Confidentiality
There is a potential risk of breach of confidentiality that is inherent in all research protocols. 
There is a possibility that if research data were to become known to others, this knowledge could 
potentially impact a subject's future or have a negative impact on family or social relationships.  
 
Although every reasonable effort has been taken, confidentiality during Internet communication 
activities cannot be guaranteed and it is possible that additional information beyond that 
collected for research purposes may be captured and used by others not associated with this 
study. 
 
The text messages you will receive as part of this study are sent from a secure, encrypted system, 
and all of your responses are stored in this secure system. However, the text messages you send 
are not encrypted or secure during transmission and could be intercepted. These text messages 
will include information about pain medication that you may be currently taking. Therefore, it is 
important to understand your text message response is not protected, and it is possible that it may 
be viewed by others. It is important to note that depending on your cell phone carrier, even if you 
delete the text message from your phone, your cell phone carrier will retain those messages for 
an extended period of time. Additionally, depending on your specific device or carrier, copies of 
those messages may be stored on multiple devices and/or related cloud storage services. 
You are responsible for the security of any information that is stored on your cell phone or 
mobile device. We suggest you periodically check for and delete any sensitive information that 
may be contained in these text messages. 
 
Unknown Risks 
As with any experimental procedure, there may be adverse events or side effects that are 
currently unknown and certain of these unknown risks could be permanent, severe or life-
threatening. 
 
What are the possible benefits from being in this research study? 
It is possible that your pain management may improve with this new method of ingesting 
medication.  Other people with chronic pain and difficulty swallowing pills may also benefit in 
the future from what we learn in this study. 
 


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What other treatments or procedures are available for my condition? 
You do not have to take part in this research study in order to receive treatment for chronic pain. 
Several opioid and non-opioid medications, treatments, and procedures are available to treat 
chronic pain. There are other opioid pain medications that can be opened and sprinkled onto 
food, including Kadian and morphine ER. Talk with the study doctor if you have questions about 
any of these treatments or procedures. 
 
You will be promptly notified if any new information we learn during this research study may 
cause you to change your mind about continuing to participate in this study. 
 
What if I want to stop taking part in the study? 
You can, at any time withdraw from this research study; you can also withdraw your 
authorization for us to use your identifiable medical information for the purposes described 
above. This means that you will also be withdrawn from further participation in this research 
study. Any identifiable research or medical information obtained as part of this study prior to the 
date that you withdrew your consent will continue to be used and disclosed by the investigators 
for the purposes described above. 
1.
To formally withdraw from this research study, you should provide a written and dated 
notice of this decision to the principal investigator of this research study at the address 
listed on the first page of this form. Your decision to withdraw from this study will have 
no effect on your current or future relationship with the University of Pittsburgh.  
2.
Your decision to withdraw your consent for participation in this research study will have 
no effect on your current or future medical care at a UPMC hospital or affiliated health 
care provider or your current or future relationship with a health care insurance provider.  
3.
If you decide to withdraw from study participation after you have received the study 
drug, you should participate in additional monitoring follow-up procedures that are being 
conducted. 
Stopping the Study Early 
If you decide to stop taking part in the study for any reason, we will ask you to make a final 
study visit. You will need to return all unused study drug at this visit. The final study visit will 
take about 2 hours at UPMC Pain Medicine at Centre Commons. At this visit, we will: 
• Ask you questions about side effects or health problems since your last visit  
• Give you some questionnaires to fill out 
• Give you a schedule for tapering off of the study medication  
Also, the study doctor may take you out of the study without your permission. This may happen 
because: 
• The study doctor thinks it is best for you to stop taking the study drug  
• You cannot make the required study visits 
• We stop doing the study for other reasons 
If this happens, the study doctor will explain why you need to stop taking part in the study. We 
will ask you to come in for a final study visit as described above.  


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Will I be paid to take part in this research study? 
You will receive a total of $120 for completing the study, detailed as follows: 
Week 1 (Initial Evaluation): $20 
Week 6 (End of Study): $100 
This totals $120 if you complete the study. 
 
If you are participating in other research studies and your total compensation for research is 
greater than $600 in a year, this will be reported to the Internal Revenue Service (IRS) as 
income. 
 
How much will I have to pay to take part in this research study? 
The study medication is paid for by Collegium Pharmaceuticals and provided at no cost to you 
during the 6-week study. If you choose to keep taking Xtampza ER after the end of the study, 
your insurance might not cover the cost of this drug. We will reimburse you for your parking in 
the clinic parking lot during study visits or bus fare to and from the study site.  
Although study funds will pay for certain study-related items and services, we may bill your 
health insurer for, among other things, routine items and services you would have received even 
if you did not take part in the research. You will be responsible for payment of any deductibles 
and co-payments required by your insurer for this routine care or other billed care. You will not 
be billed for any study-related procedures or services. 
 
If you have any questions about costs to you that may result from taking part in the research, 
please speak with the study doctors and study staff.  
 
What happens if I am injured as a result of taking part in this research study? 
If you believe that the research procedures have resulted in an injury to you, immediately contact 
the Principal Investigator who is listed on the first page of this form. Collegium Pharmaceuticals, 
the manufacturer of Xtampza ER, has agreed to compensate research subjects for all medical 
expenses incurred for the emergency and/or long-term treatment of any injury that is directly a 
result of Collegium’s manufacture, packaging, or labeling of Xtampza ER, or negligence of 
willful misconduct on the part of Collegium. 
 
Emergency medical treatment for injuries solely and directly related to your participation in this 
research study, and not related to the manufacturer, packaging or labeling of Xtampza, will be 
provided to you by the hospitals of UPMC. Your insurance provider may be billed for the costs 
of this emergency treatment, but none of those costs will be charged directly to you. If your 
research-related injury requires medical care beyond this emergency treatment, you will be 
responsible for the costs of this follow-up care. At this time, there is no plan for any additional 
financial compensation. You do not give up any of your legal rights by signing this form. 
 
Will this research study involve the use or disclosure of my identifiable medical information? 
We are requesting your authorization or permission to review your medical records.  This 
research study will involve the recording of past, current and/or future identifiable (pertaining to 
only you) medical information from your hospital and/or other health care provider (for example, 


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your physician’s office) records. This information that will be recorded will be limited to 
information concerning the study (for example, diagnostic information, lab and scan results, 
medications, medical history). This information will be used to determine your eligibility for this 
study and to follow you once you are enrolled in the study.  This authorization is valid for an 
indefinite period of time.
This research study will also result in identifiable information that will be placed into your 
medical records held at UPMC. The nature of the identifiable information resulting from your 
participation in this research study that will be recorded in your medical record includes 
medications prescribed and a note that you are or have participated in this study. 
Who will have access to identifiable information related to my participation in this research 
study? 
In addition to the investigator listed on the first page of this consent form and the research staff, 
the following individuals will or may have access to identifiable information related to your 
participation in this research study:  
1.
Authorized representatives of the University of Pittsburgh Research Conduct and 
Compliance Office may review your identifiable research information (which may 
include your identifiable medical record information) for the purpose of monitoring the 
appropriate conduct of this research study.  
2.
In unusual cases, the investigators may be required to release your identifiable research 
information (which may include your identifiable medical record information) in 
response to an order from a court of law. If the investigators learn that you or someone 
with whom you are involved is in serious danger or potential harm, they will need to 
inform the appropriate agencies, as required by Pennsylvania law. 
3.
Authorized representative of the U.S. Food and Drug Administration (FDA) and other 
regulatory agencies may review and/or obtain your identifiable information (which may 
include your identifiable medical record information) related to your participation in this 
research study for the purpose of monitoring the accuracy of the research data. 
4.
Authorized representatives of the UPMC hospitals or other affiliated health care 
providers may have access to your identifiable information (which may include your 
identifiable medical record information) for the purpose of (1) fulfilling orders, made by 
the investigators, for hospital and health care services (such as laboratory tests, diagnostic 
procedures) associated with research study participation; (2) addressing correct payment 
for tests and procedures ordered by the investigators; and (3) for internal hospital 
operations (i.e. quality assurance). 
 
The data from this study may be shared with other investigators; however, only data without 
identifiers (such as your name) will be shared. 
 
We will protect your privacy and the confidentiality of your research records, as described in this 
document, but cannot guarantee the confidentiality of your research records, including 
information obtained from your medical records, once your personal information is disclosed to 
others outside UPMC or the University. 
 


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ttsbu g
     Institutional Review Boar d    
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Appr oval D ate: 2/9/2018 
pp o a
ate
/9/ 0 8
Renewal D ate:  10/24/2018 
 
IRB #:   PRO17040444 
IRB
 
 
For how long will the investigators be permitted to use and disclose identifiable information 
related to my participation in this research study? 
The investigators may continue to use and disclose, for the purposes described above, 
identifiable information (which may include your identifiable medical information) related to 
your participation in this research study for a minimum of 7 years following final reporting and 
publication of the study and for as long (indefinite) as it may take to complete this research 
study. 
Your rights as a research subject 
Your participation in this research study, to include the use and disclosure of your identifiable 
information for the purposes described below, is completely voluntary. Note, however, that if 
you do not provide your consent for the use and disclosure of your identifiable medical record 
information for the purposes described above, you will not be allowed, in general, to participate 
in the research study. 
 
You may want to discuss this study with your family and friends and your personal physician 
before agreeing to participate. If there are any words you do not understand, feel free to ask us. 
The researchers will be available to answer your current and future questions. 
 
Whether or not you provide your consent for participation in this research study will have no 
effects on your current or future relationship with the University of Pittsburgh, your current or 
future medical care at a UPMC hospital or affiliated health care provider, or your current or 
future relationship with a health care insurance provider. 
 
To formally withdraw your consent for participation in this research study, you should provide a 
written and dated notice of this decision to the principal investigator at the address listed on the 
first page of this form. 
 
If you have any questions about your rights as a research subject or wish to talk to someone other 
than the research team, please call the University of Pittsburgh Human Subjects Protection 
Advocate toll-free at 866-212-2668.  
 
****************************************************************************** 
 
 
 
 
 
 
VOLUNTARY CONSENT 
The above information has been explained to me, and all of my current questions have been 
answered. I understand that I am encouraged to ask questions, voice concerns or complaints 
about any aspect of this research study during the course of this study, and that such future 
questions, concerns or complaints will be answered by a qualified individual or by the 
investigator listed on the first page of this consent document at the telephone number given.  


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   Univer sity Of Pittsburgh          
U
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     Institutional Review Boar d    
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Appr oval D ate: 2/9/2018 
pp o a
ate
/9/ 0 8
Renewal D ate:  10/24/2018 
 
IRB #:   PRO17040444 
IRB
 
 
I understand that I may always request that my questions, concerns or complaints be addressed 
by a listed investigator. I understand that I may contact the Human Subjects Protection 
Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, 
concerns, and questions; obtain information; offer input; or discuss situations that occurred 
during my participation.  
By signing this form I consent to participate in this research study and provide my authorization 
to share my medical records with the research team. A copy of this consent form will be given to 
me.  
____________________________
____________________________
____________
Participant’s Signature 
Printed Name of Participant 
Date/Time 
CERTIFICATION of INFORMED CONSENT 
I certify that I have explained the nature and purpose of this research study to the above-named 
individual, and I have discussed the potential benefits and possible risks of study participation.  
Any questions the individual has about this study have been answered, and we will always be  
available to address future questions as they arise. I further certify that no research component of 
this protocol was begun until after this consent form was signed. 
 
 
 
___________________________________  
________________________ 
Printed Name of Person Obtaining Consent  
Role in Research Study 
 
 
__________________________________   
____________ 
Signature of Person Obtaining Consent 
 
Date/Time