Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties (NCT05463341) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties
United States2,400 participantsStarted 2022-09-09
Plain-language summary
The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select Project DAWN sites in rural and urban communities in Ohio.
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:
* Age 18 years or older
* Visitor to a Project DAWN site in Ohio that does not currently distribute FTS and has agreed to participate in the study
* Self-reported use of illicit drugs or prescription drugs purchased on the street within the past 6 months
* Has a phone number or email address to allow for follow-up contact
* Understands English (Based on the 2012-2016 American Community Survey, only 2.4% of Ohioans 5 years and older speak English less than "very well.")
Exclusion Criteria:
\- None (must meet inclusion criteria)
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
Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
Timeframe: Quarter 2 of Year 1
2
Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
Timeframe: Quarter 3 of Year 5
3
Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
Timeframe: Quarter 2 of Year 5
4
Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
Timeframe: 6-month follow-up
5
Test the hypothesis that PWUD who receive FTS education and testing materials as part of an OEND program will have improved knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for lowering their risk of an opioid overdose.
Test the hypothesis that individuals who receive FTS education and testing materials as part of an OEND program will have a lower opioid overdose rate than individuals who receive OEND only ("usual practice").