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Opiate OverdoseNCT05463341

Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties

A study testing Fentanyl Test Strips in people with Opiate Overdose and Fentanyl Overdose, run by Nationwide Children's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opiate Overdose, Fentanyl Overdose, Harm Reduction
What is being tested?
Fentanyl Test Strips
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
1 siteUnited States
Study dates
9 Sep 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.")

Who cannot join

  • None (must meet inclusion criteria)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

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.

Read the detailed description

Purpose: Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips (FTS) test for the presence of some types of fentanyl in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. FTS use is a promising harm reduction strategy and research shows when people who use drugs (PWUD) receive a positive result, they are more likely to perform overdose risk reduction behaviors. However, access to FTS is limited, and there are barriers to the adoption of this intervention in some communities. This study will investigate FTS distribution and education as a harm reduction strategy to prevent overdoses among PWUD. Study findings will contribute valuable information about the feasibility and acceptability of integrating FTS drug checking into Project DAWN sites in rural and urban communities in Ohio and help us achieve our long-term goal of reducing overdose deaths.

Study Design: Project DAWN sites that volunteer to participate in the study will be randomly assigned to either the intervention or non-intervention arm of the study.

Clients in the intervention arm of the study will receive:

  • One-on-one education on the purpose, benefits, and limitations of FTS testing
  • A brief 20-minute fentanyl test strip educational intervention, including a 2-3-minute video and hands-on demonstrations on how to use FTS
  • A supply of FTS upon enrollment and throughout the 2-year follow up period

Clients in the non-intervention arm of the study will receive:

  • FTS education and a supply of FTS will be offered to participants in the non-intervention arm in the last year of the study

Consent: Written documentation of informed consent will be obtained from all participants.

Incentives: Participants will be compensated for their time with a gift cards for completing the baseline survey, the survey at 6-months, and each biweekly survey.

Recruitment and Retention: Having a close partnership with Project DAWN sites will help us recruit and retain study participants. In addition to key informant interviews in year one and questionnaires in year five, the research team will survey coordinators quarterly to collect data on Project DAWN site and coordinator experiences, identify concerns, and take corrective actions. The investigators will also maintain regular communication with Project DAWN site coordinators when the study staff are onsite.

The research team will handle all enrollment of study clients, delivery of the FTS intervention, and follow up with study participants. Project DAWN sites will be asked to provide a small space for the research team to enroll participants and provide the FTS intervention (if applicable). The sites will also be asked to refer potentially eligible individuals to the research team at times when they are on-site.

Being tested
Fentanyl Test Strips
Medical subject headings
Opiate Overdose, Harm Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fentanyl Test StripsBehavioural

    A brief fentanyl test strip (FTS) education intervention will be given to participants at Project DAWN sites in the intervention arm after enrollment and collecting baseline data. It will be offered one-on-one with participants and will include the purpose, benefits, and limitations of FTS testing, and information on how to use FTS, interpret the results, what to do if the FTS is positive, and how to use FTS for different drug delivery methods. Participants will practice and demonstrate use of the FTS, and the short video on how to interpret the FTS will include an on-camera statement on the importance of testing for fentanyl. The video will be accessible to participants after study enrollment. Participants will be advised of the possibility of both false positive/negative results, and that the drugs may be mixed with other substances not detectable with FTS. Participants will be encouraged to practice other harm reduction strategies.

Study groups in NCT05463341
Study groupRoleWhat they receive
Intervention ArmExperimentalEach participant in the intervention arm will receive one-on-one education on the purpose, benefits, and limitations of fentanyl test strip (FTS) testing and undergo a brief 20-minute FTS educational intervention (including a 2-3-minute video and hands-on demonstrations on how to use FTS). They will also receive a supply of 10 FTS upon enrollment and continued supply upon request throughout the 2-year follow up period.
Receives: Behavioral: Fentanyl Test Strips
Non-Intervention ArmNo interventionFentanyl test strip (FTS) education and a supply of FTS will be offered to participants in the non-intervention arm of the study during the final quarter of year 5.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.

    Key informant interviews with all site personnel and peer recovery mentors.

    Quantitative Data/Process Measures:

    • # interested Project DAWN sites
    • # Project DAWN sites enrolled
    • # potential participants who request to enroll
    • # participants successfully enrolled
    • # people who receive FTS education and testing materials at baseline
    • # replacement FTS requested/distributed
    • total # FTS distributed
    • proportion of participants in the intervention arm who complete the biweekly surveys
    • proportion of participants who complete the 6-month follow-up questionnaire

    Measured: 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.

    Follow up with intervention arm site personnel to gauge satisfaction with the program and identify any concerns.

    Quantitative Data/Process Measures:

    • # interested Project DAWN sites
    • # Project DAWN sites enrolled
    • # potential participants who request to enroll
    • # participants successfully enrolled
    • # people who receive FTS education and testing materials at baseline
    • # replacement FTS requested/distributed
    • total # FTS distributed
    • proportion of participants in the intervention arm who complete the biweekly surveys
    • proportion of participants who complete the 6-month follow-up questionnaire

    Measured: 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.

    Interview intervention arm site personnel to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites.

    Quantitative Data/Process Measures:

    • # interested Project DAWN sites
    • # Project DAWN sites enrolled
    • # potential participants who request to enroll
    • # participants successfully enrolled
    • # people who receive FTS education and testing materials at baseline
    • # replacement FTS requested/distributed
    • total # FTS distributed
    • proportion of participants in the intervention arm who complete the biweekly surveys
    • proportion of participants who complete the 6-month follow-up questionnaire

    Measured: 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.

    Interview intervention arm sites about the acceptability of the program.

    Quantitative Data/Process Measures:

    • # interested Project DAWN sites
    • # Project DAWN sites enrolled
    • # potential participants who request to enroll
    • # participants successfully enrolled
    • # people who receive FTS education and testing materials at baseline
    • # replacement FTS requested/distributed
    • total # FTS distributed
    • proportion of participants in the intervention arm who complete the biweekly surveys
    • proportion of participants who complete the 6-month follow-up questionnaire

    Measured: 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.

    All participants (in both the intervention and non-intervention arms) will complete a questionnaire at enrollment (for the intervention group, prior to the intervention) and again at 6 months. Both questionnaires (baseline and 6 months) will include the same questions about the participant's knowledge of and self-efficacy in reducing their risk of an opioid overdose by using FTS (Appendix). Participants will be compensated for their time with gift cards for completing the questionnaires.

    Measured: 6-month follow-up

  6. 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").

    Participants in the intervention arm will be contacted biweekly for 2 years and asked if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Intervention arm participants will be asked to notify the study team when they receive a positive FTS result. Participants in the non-intervention arm will be contacted biweekly up to a maximum of 2 years after enrollment to ask if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Fatal overdoses among participants in the intervention and non-intervention arms of the study will be identified by reviewing death certificates issued by the Ohio Department of Health quarterly starting in Year 2. Participating Project DAWN sites will be asked to advise the study team if they become aware of any fatal overdoses among clients who are enrolled in the study.

    Measured: Quarter 3 of Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start9 Sep 2022
  3. Primary completion29 Apr 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05463341
Sponsor's protocol ID
NCH
Status last verified
May 2026
First submitted
1 Jun 2022
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified information on the number of overdoses reported to research staff by study participants and what drug the participant thought they were using at the time will be shared with the Ohio Department of Health's Violence and Injury Prevention Section. Personal stories of potential overdoses averted by use of FTS will be shared in a de-identified form in future trainings.

Publications

  • Short Mejia A, Smith GA, Fernandez SA, Freisthler B, Grella C, Michaels NL. Evaluating fentanyl test strips as a harm reduction strategy in rural and urban counties: study protocol for a randomized controlled trial. Trials. 2024 Sep 4;25(1):587. doi: 10.1186/s13063-024-08440-y.

    PubMed 39232778

Questions about this trial

What is this clinical trial studying?

A study testing Fentanyl Test Strips in people with Opiate Overdose and Fentanyl Overdose, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties. (time frame: Quarter 2 of Year 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463341, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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