Prescription Opioid Discontinuation: Honoring Patient Insights and Experience to Support Safe and… (NCT07202026) | Clinical Trial Compass
By InvitationNot Applicable
Prescription Opioid Discontinuation: Honoring Patient Insights and Experience to Support Safe and Caring Transitions -- Decision Aid Pilot
United States30 participantsStarted 2025-10-29
Plain-language summary
Because of recent policies to decrease opioid use, some people using long-term opioid therapy (LTOT) are encouraged or required to stop (discontinue) taking opioids. That has led experts to be concerned that patients whose LTOT is discontinued could have untreated pain, turn to other substance use and possibly illicit opioids, or have worsened mental health symptoms leading to suicide. To guide safer policies, guidelines, and care, this study will interview patients and doctors about discontinuing LTOT and use the results to develop a patient-centered decision aid (DA) to improve patient-provider communication around discontinuation of LTOT. Once the DA is finalized, it will be pilot tested with a group of 30 patients who are currently on LTOT. The pilot will assess DA implementation feasibility; acceptability; knowledge transfer; and ability to successfully foster positive, patient-centered conversations about opioid discontinuation.
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.
EHR-based inclusion criteria:
* age 18 or older
* LTOT in the past 18 months (LTOT is ≥60 days of ≥50 MEDs day in each of 2 consecutive 90-day periods with medication treatment for OUD excluded)
Inclusion criteria confirmed by participant
* Have been taking opioids for chronic pain for at least 6 months
* Able to speak and read English
EHR-based exclusion criteria:
* cancer diagnosis in the last 5 years (excluding non-melanoma skin cancers)
* current palliative or hospice care
* cognitive disability
* psychiatric hospitalization in the last year
* surgery in the last 6 months
* current residence in an inpatient rehabilitation or skilled nursing facility
Exclusion criteria determined by study
\- participated in an interview for Aim 1 of this study
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.