Fentanyl Test Strips for Preventing Opioid Overdose

Overseen By Ashley Short Mejia, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and practicality of fentanyl test strips in preventing opioid overdoses at specific Project DAWN sites in Ohio. Participants in the intervention group will learn to use these strips and receive a supply for ongoing use. The researchers aim to determine if these strips can reduce overdose risks. Individuals who have used street-purchased drugs in the past six months and visit Project DAWN sites in Ohio are suitable candidates for this study. As an unphased trial, this study allows participants to contribute to important research that could enhance community safety and save lives.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that fentanyl test strips are safe for use?

Research has shown that fentanyl test strips (FTS) provide a safe method to check for fentanyl in drugs. These strips are easy to use and legal in places like Rhode Island. Studies have found that FTS can help people avoid overdoses. Since users do not consume the strips, they remain safe; they simply test drugs before use. FTS contribute to broader efforts to reduce the risk of opioid overdoses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of fentanyl test strips (FTS) because they offer a proactive approach to preventing opioid overdoses. Unlike traditional treatments that primarily address overdoses after they occur, such as naloxone, FTS allow users to test substances for the presence of fentanyl before use. This empowers users with critical information, potentially reducing the risk of accidental overdoses. The test strips are easy to use, offering a simple and rapid way to detect fentanyl, which is a major contributor to opioid-related fatalities.

What evidence suggests that fentanyl test strips are effective for preventing opioid overdose?

Research has shown that fentanyl test strips (FTS) can help people modify their drug use and feel safer about avoiding overdoses. One study found that 43% of users changed their drug use after using FTS, and 77% felt more secure about overdose risks. Participants in the intervention arm of this trial will receive education and a supply of FTS, which are linked to actions that lower the chance of overdosing, highlighting their importance in harm reduction. Young adults are particularly open to using FTS to check for fentanyl in street drugs. These strips are affordable and have proven effective in accurately detecting fentanyl in drug samples, which can help prevent overdoses when used with other safety measures. ^{1 2 5 6 7}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Ohio who use street-bought drugs or prescriptions and can be contacted by phone or email. They must understand English and visit a Project DAWN site that's part of the study.

Inclusion Criteria

I visited a Project DAWN site in Ohio that doesn't give out FTS and agreed to join the study.

Self-reported use of illicit drugs or prescription drugs purchased on the street within the past 6 months

I have a phone number or email for follow-ups.

Exclusion Criteria

None (must meet inclusion criteria)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive one-on-one education on FTS, a 20-minute educational intervention, and a supply of FTS.

2 years

Biweekly contacts

Non-Intervention

Participants in the non-intervention arm receive FTS education and supply in the final quarter of year 5.

Final quarter of year 5

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biweekly contacts and quarterly death certificate reviews.

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl Test Strips

Trial Overview The study is testing if teaching people how to use Fentanyl Test Strips (FTS) at certain Project DAWN sites helps prevent overdoses in both rural and urban areas.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

Group II: Non-Intervention Arm Active Control 1 Intervention

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 5.

Fentanyl Test Strips is already approved in United States for the following indications:

Approved in United States as Fentanyl Test Strips for:

• Detection of fentanyl in illicit drugs for harm reduction and overdose prevention

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Published Research Related to This Trial

A study of 105 individuals on medication for opioid use disorder revealed that 63% had experienced a non-fatal overdose, highlighting the urgent need for effective overdose prevention strategies.

While 85% of participants expressed willingness to use fentanyl test strips (FTS), only 17% had actually used them, indicating a significant gap in awareness and education about FTS as a preventive measure against fentanyl-related overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fentanyl Test Strip Use and Overdose History among Individuals on Medication for Opioid Use Disorder. Mistler, CB., Rosen, AO., Eger, W., et al.[2022]

A pilot study involving 30 treatment-seeking individuals revealed that while 80% recognized that illicitly manufactured fentanyls (IMFs) are more dangerous than heroin, many lacked confidence in using fentanyl test strips (FTS) for harm reduction, with only 17% feeling capable of using them effectively.

The study highlighted a significant gap in knowledge about FTS among clients, particularly those using nonopioid drugs, indicating a need for increased education and access to these tools to help prevent overdose deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study assessing client understanding and use of fentanyl test strips for harm reduction. Barrolle, AA., Gable, KN., Dell, N.[2023]

In a study of 341 syringe service program clients, the use of fentanyl test strips was linked to an increase in both safer and riskier drug use behaviors, indicating a complex relationship between testing and behavior change.

A positive test result for fentanyl was associated with more safer behaviors and fewer riskier behaviors, although these associations became less significant when accounting for factors like polysubstance use and age, highlighting the need for comprehensive harm reduction strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in drug use behaviors that impact overdose risk among individuals who do and do not use fentanyl test strips for drug checking. Tilhou, AS., Zaborek, J., Baltes, A., et al.[2023]

Emergency department staff found that distributing fentanyl test strips (FTSs) to patients who use drugs was beneficial, improving patient interactions and providing essential tools for overdose prevention.

Despite positive feedback, staff identified challenges in integrating FTS distribution into their workflow, suggesting the need for training and systematic approaches to make FTS distribution a routine part of emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot testing fentanyl test strip distribution in an emergency department setting: Experiences, lessons learned, and suggestions from staff. Reed, MK., Salcedo, VJ., Hsiao, T., et al.[2023]

Fentanyl test strip (FTS) programs in Baltimore and Delaware showed high utilization rates among people who use drugs (PWUD), with 70% and 77% of participants using the strips to test their drugs, respectively.

The programs led to significant risk reduction behaviors, with 23% of respondents in Baltimore and 69% in Delaware adopting safer practices after testing their drugs, indicating that FTS can effectively promote awareness and reduce overdose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of fentanyl test strip distribution in two Mid-Atlantic syringe services programs. Park, JN., Frankel, S., Morris, M., et al.[2021]

In a survey of 458 people who inject drugs in San Francisco, 45.4% reported using fentanyl test strips (FTS) in the past year, indicating a significant but not universal adoption of this harm reduction tool.

Among those who used FTS, 80.2% tested positive for fentanyl, leading to varied responses: 43.4% continued using the drug, 26.5% chose to abstain, and 30.1% reduced their dosage, highlighting the potential of FTS to influence drug use behavior and prevent overdose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fentanyl self-testing in a community-based sample of people who inject drugs, San Francisco. Oh, H., Kim, K., Miller, D., et al.[2021]

A study of 251 synthetic opioids, including 214 fentanyl analogs, found that two brands of fentanyl test strips (BTNX and DanceSafe) have different detection capabilities, with 121 compounds detectable by both brands and 80 detectable by only one brand.

The detection differences are due to the specific chemical structures of the fentanyl analogs, where modifications to certain parts of the molecule can inhibit detection; using both brands of test strips can improve the likelihood of identifying fentanyl analogs that might otherwise go undetected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of two brands of fentanyl test strips with 251 synthetic opioids reveals "blind spots" in detection capabilities. Hayes, KL., Lieberman, M.[2023]

Citations

1. cdc.gov cdc.gov/stop-overdose/safety/index.html

What You Can Do to Test for Fentanyl | Stop Overdose Fentanyl test strips (FTS) are a low-cost harm reduction tool that can be used to prevent overdoses in combination with other strategies.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0955395918302135

Fentanyl test strips as an opioid overdose prevention strategy For the outcomes, 43% reported a change in drug use behavior and 77% indicated increased perceived overdose safety by using FTS. In multivariable models ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833888

Fentanyl Test Strip Use and Overdose Risk Reduction ... These findings suggest that FTS use is associated with overdose risk reduction behaviors, demonstrating the role of FTS as a harm reduction strategy among PWUD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6701177/

Use of Rapid Fentanyl Test Strips Among Young Adults ... Conclusions: Young adults reported high uptake and acceptability of fentanyl test strips to detect IMF in illicit drugs. Keywords: Overdose, Opioids, ...

5. cdph.ca.gov cdph.ca.gov/Programs/CID/DOA/CDPH%20Document%20Library/Fact_Sheet_Fentanyl_Testing_Approved_ADA.pdf

Fact Sheet: Fentanyl Testing to Prevent Overdose - CDPH The study found that the test strips were accurate at detecting fentanyl when it was present in samples of street drugs provided by law ...

6. preventoverdoseri.org preventoverdoseri.org/fentanyl-test-strips/

Fentanyl Test Strips Fentanyl test strips are easy to use tests to see if your drugs have some types of fentanyl in them. Fentanyl test strips have been legal in Rhode Island since ...

7. samhsa.gov samhsa.gov/substance-use/treatment/overdose-prevention/fentanyl-xylazine-test-strips

Fentanyl and Xylazine Test Strips FTS are small strips of paper that can be used to determine if drugs have been mixed or contaminated with fentanyl.