Fentanyl Test Strips for Drug 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 explores the effectiveness and practicality of fentanyl test strips in certain Ohio courts. The study aims to determine if educating participants about these strips can reduce drug overdoses. Participants will be divided into two groups: one will receive education on fentanyl test strips and their use, while the other will receive this information at the trial's conclusion. Ideal candidates have used illegal stimulants in the past six months and are enrolled in specific drug court programs in Ohio. As an unphased trial, this study allows participants to contribute to important research that could promote safer drug use practices.

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

The trial protocol 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) are generally safe to use. These strips detect fentanyl, a potent synthetic opioid, in drugs. Studies indicate that FTS use can prompt individuals to alter their drug use and feel safer from overdoses. In one study, 77% of participants felt more confident about avoiding an overdose after using the strips.

The strips are easy to use and have received legal approval in places like Rhode Island. They serve as a harm reduction strategy, helping to lessen the negative effects of drug use without requiring complete abstinence.

Overall, fentanyl test strips are well-tolerated and assist people in making safer choices. No serious side effects have been reported from using the test strips themselves. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of fentanyl test strips (FTS) for drug overdose prevention because these strips offer a proactive approach to detecting fentanyl in drugs before they are consumed. Unlike typical treatments that focus on responding to an overdose, such as naloxone, FTS empowers users to make safer choices by identifying the presence of fentanyl, a highly potent opioid, in their substances. This method fosters harm reduction by potentially preventing overdoses before they occur, which is a significant shift from the reactive nature of standard overdose treatments. Additionally, FTS education enhances users' understanding of the risks associated with fentanyl, promoting safer drug use practices.

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

Research has shown that fentanyl test strips (FTS) can help lower the risk of overdose. One study found that 43% of people changed their drug use after using FTS, and 77% felt safer from overdoses. Another study linked FTS use to actions that reduce overdose risks. In this trial, participants in the intervention arm will receive education and a supply of FTS to assess its impact on overdose prevention. Young adults have widely accepted and used FTS to check for fentanyl in drugs. Overall, FTS is considered an effective harm reduction tool, making drug use safer by reducing the chances of an overdose. ^{1 2 4 5 6}

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 English, have contact info for follow-ups, are not in jail, and use illicit stimulants. They must be enrolled in specific Ohio drug courts or on probation with them.

Inclusion Criteria

Not incarcerated at time of study enrollment

I have a phone or email for follow-ups.

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

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 and naloxone kits.

2 years

Regular visits for FTS and naloxone supply

Non-Intervention

Participants in the non-intervention arm receive opioid overdose education and naloxone kits, with FTS education offered in the last year.

2 years

Regular visits for naloxone supply

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including a 6-month follow-up questionnaire.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl Test Strips

Trial Overview

The study tests if teaching about and giving out Fentanyl Test Strips (FTS) in certain Ohio courts can help prevent overdoses from drugs like opioids and fentanyl.

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. 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.

Group II: Non-Intervention Arm Active Control 1 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.

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

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]

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]

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]

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]

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]

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]

Citations

1.

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 ...

2.

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.

3.

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, ...

4.

cdc.gov

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

What You Can Do to Test for Fentanyl | Stop Overdose

Using fentanyl test strips can help you lower your risk of overdose. Positive results. A single pink line on the left-hand side indicates ...

5.

harmreductionjournal.biomedcentral.com

harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-023-00767-0

Differences in drug use behaviors that impact overdose risk ...

Fentanyl test strip use is associated with behaviors that may impact overdose risk, including safer and riskier behaviors.

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 ...