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 range18 Years
SexALL
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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
✓. Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
Exclusion criteria
✕. Under 18 years of age
✕. Have cancer-related pain
✕
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
. 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