Pain Self-Management and Treatment Engagement for Patients Taking Opioids (NCT06855732) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
United States204 participantsStarted 2024-11-25
Plain-language summary
The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are:
* Does PSM help participants manage their chronic pain more effectively?
* Does PSM help participants engage in treatment for opioid use?
Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment.
Participants will:
* Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study
* Complete surveys every 3 months for 9 months (total of 4 visits)
Participants will receive compensation for participating in the study.
There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults at least 18 years old
. Ability to speak, read, and understand English
. Capable of providing informed consent
. Access to phone and/or internet
. Current (defined as at least 1 primary care visit in the past 3 years) or new (confirmed appointment) primary care patient at a participating clinic
. Must meet criteria for OUD or opioid misuse based on at least one of the following:
. OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
. Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
Exclusion criteria
. Under 18 years of age
. Have cancer-related pain
. Are currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action that could prevent participation in study activities
. Have received prescribed, administered, or dispensed MOUD (buprenorphine, methadone, naltrexone) as maintenance treatment for OUD (excluding acute or short-term (\< 7 days) use of these medications to manage opioid withdrawal or pain management) within the past 90 days
. Had an intentional suicide attempt within the past 3 months