Opiate OverdoseNCT05493475
Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants
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.
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 courts 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 653 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Not incarcerated at time of study enrollment
- Currently enrolled in one of the following Ohio drug courts: Criminal drug court, Veterans' court, Mental health court, Human trafficking court, Family treatment court, O.V.I. court or on probation with a participating court
- Self-reported use of illicit stimulants in 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, 43207
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 courts 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 court sites in rural and urban communities in Ohio and help study personnel achieve the long-term goal of reducing overdose deaths.
Study Design: Court 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
- Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period
Clients in the non-intervention arm of the study will receive:
- Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period
- 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.
Recruitment and Retention: Having a close partnership with the Supreme Court of Ohio will help study staff recruit and retain study participants. In addition to key informant interviews in year one and questionnaires in year three, the research team will survey court managers quarterly to collect data on the court's satisfaction with the program and identify any areas of concern. The investigators will also maintain regular communication with court personnel 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. Court 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.
- Conditions
- Opiate Overdose, Fentanyl Overdose, Harm Reduction
- 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 court 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 group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Each 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. Each participant will also receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. Receives: Behavioral: Fentanyl Test Strips |
| Non-Intervention Arm | No intervention | Each participant will receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. Fentanyl 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 3. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key informant interviews
Key informant interviews will be conducted with court personnel and peer recovery mentors who are affiliated with the court sites to discuss and obtain feedback on the intervention design and research protocols. Key informants will be asked to provide feedback on participant recruitment strategies, discuss potential barriers to the program's success, and describe any concerns with the implementation plan.
Quantitative Data/Process Measures:
- # interested court sites
- # Court sites enrolled
- # potential participants who request to enroll
- # participants successfully enrolled
- # people who receive FTSED and OEND at baseline
- # replacement FTS and Naloxone kits requested/distributed
- total # FTS and Naloxone kits 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
Follow-up questionnaire
A follow-up questionnaire will occur with intervention arm site personnel to gauge satisfaction with the program and identify any concerns.
Quantitative Data/Process Measures:
- # interested court sites
- # Court sites enrolled
- # potential participants who request to enroll
- # participants successfully enrolled
- # people who receive FTSED and OEND at baseline
- # replacement FTS and Naloxone kits requested/distributed
- total # FTS and Naloxone kits 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 3
Interview
Intervention arm site personnel will be interviewed to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites.
Quantitative Data/Process Measures:
- # interested court sites
- # Court sites enrolled
- # potential participants who request to enroll
- # participants successfully enrolled
- # people who receive FTSED and OEND at baseline
- # replacement FTS and Naloxone kits requested/distributed
- total # FTS and Naloxone kits 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 3
Interview
Intervention arm sites will be interviewed about the acceptability of the program.
Quantitative Data/Process Measures:
- # interested court sites
- # Court sites enrolled
- # potential participants who request to enroll
- # participants successfully enrolled
- # people who receive FTSED and OEND at baseline
- # replacement FTS and Naloxone kits requested/distributed
- total # FTS and Naloxone kits 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
Questionnaire
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.
Measured: 6-month follow-up
Questionnaire
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.
Measured: Quarter 3 of Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start10 Nov 2022
- Primary completion30 Aug 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate OverdoseStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nichole Michaels, Nationwide Children's Hospital
- Investigators
- Nichole Michaels, PhD, Principal investigator, Nationwide Children's Hospital, Center for Injury Research & PolicyGary Smith, MD, DRPH, Principal investigator, Nationwide Children's Hospital, Center for Injury Research & Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493475
- Sponsor's protocol ID
- Nationwide Children's Hospital
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to de-identified IPD may be requested by qualified researchers within the scientific community after publication. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants
- ClinicalTrials.gov ID
- NCT05493475
- Acronym / sponsor ID
- Nationwide Children's Hospital
- Conditions
- Opiate Overdose, Fentanyl Overdose, Harm Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select courts in rural and urban communities in Ohio.
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 court sites in rural and urban communities in Ohio and help study personnel achieve the long-term goal of reducing overdose deaths.
Study Design: Court 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
- Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period
Clients in the non-intervention arm of the study will receive:
- Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period
- 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.
Recruitment and Retention: Having a close partnership with the Supreme Court of Ohio will help study staff recruit and retain study participants. In addition to key informant interviews in year one and questionnaires in year three, the research team will survey court managers quarterly to collect data on the court's satisfaction with the program and identify any areas of concern. The investigators will also maintain regular communication with court personnel 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. Court 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Fentanyl Test StripsEach 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. Each participant will also receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. |
| Non-Intervention Arm | No intervention | –Each participant will receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. Fentanyl 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 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Not incarcerated at time of study enrollment
- Currently enrolled in one of the following Ohio drug courts: Criminal drug court, Veterans' court, Mental health court, Human trafficking court, Family treatment court, O.V.I. court or on probation with a participating court
- Self-reported use of illicit stimulants in the past 6 months
- Has a phone number or email address to allow for follow-up contact
Key exclusion criteria (1 listed)
- None (must meet inclusion criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Test StripsA brief fentanyl test strip (FTS) education intervention will be given to participants at court 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. | Behavioural | Intervention Arm |
Primary outcome
Key informant interviews
Time frame: Quarter 2 of Year 1
Key informant interviews will be conducted with court personnel and peer recovery mentors who are affiliated with the court sites to discuss and obtain feedback on the intervention design and research protocols. Key informants will be asked to provide feedback on participant recruitment strategies, discuss potential barriers to the program's success, and describe any concerns with the implementation plan. Quantitative Data/Process Measures: * # interested court sites * # Court sites enrolled * # potential participants who request to enroll * # participants successfully enrolled * # people who receive FTSED and OEND at baseline * # replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Follow-up questionnaire
Time frame: Quarter 3 of Year 3
A follow-up questionnaire will occur with intervention arm site personnel to gauge satisfaction with the program and identify any concerns. Quantitative Data/Process Measures: * # interested court sites * # Court sites enrolled * # potential participants who request to enroll * # participants successfully enrolled * # people who receive FTSED and OEND at baseline * # replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Interview
Time frame: Quarter 2 of Year 3
Intervention arm site personnel will be interviewed to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites. Quantitative Data/Process Measures: * # interested court sites * # Court sites enrolled * # potential participants who request to enroll * # participants successfully enrolled * # people who receive FTSED and OEND at baseline * # replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Interview
Time frame: 6-month follow-up
Intervention arm sites will be interviewed about the acceptability of the program. Quantitative Data/Process Measures: * # interested court sites * # Court sites enrolled * # potential participants who request to enroll * # participants successfully enrolled * # people who receive FTSED and OEND at baseline * # replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Questionnaire
Time frame: 6-month follow-up
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.
Questionnaire
Time frame: Quarter 3 of Year 3
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Access to de-identified IPD may be requested by qualified researchers within the scientific community after publication. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nichole Michaels, PhD principal investigator
Nationwide Children's Hospital, Center for Injury Research & Policy
Gary Smith, MD, DRPH principal investigator
Nationwide Children's Hospital, Center for Injury Research & Policy
1 site in 1 country: see every site and its status.
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 6 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: finished, as of the sponsor's last update on 23 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Key informant interviews (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?
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 23 Jan 2026.