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

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

2400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Fentanyl Test Strips for Preventing Opioid Overdose is an effective treatment?

The available research shows that Fentanyl Test Strips (FTS) are effective in preventing opioid overdoses by helping people identify fentanyl in their drugs. Studies indicate that FTS have received strong support from individuals with opioid dependence, as they help detect fentanyl, which is often mixed into other drugs without the user's knowledge. This awareness can lead to safer drug use practices and reduce the risk of overdose. Additionally, programs distributing FTS in syringe services have been evaluated positively, suggesting that these strips are a valuable tool in overdose prevention efforts. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Fentanyl Test Strips for preventing opioid overdose?

Research shows that fentanyl test strips can help prevent overdoses by allowing people to check if their drugs contain fentanyl, a powerful opioid often found in street drugs. Studies indicate that these strips are supported by individuals with opioid dependence and can promote awareness and reduce overdose risk. ^{1 2 3 4 5}

What safety data exists for fentanyl test strips?

The research indicates that fentanyl test strips (FTS) are widely supported by individuals with opioid dependence as a strategy to detect fentanyl in substances and prevent overdoses. They are used in various settings, including community-based programs and emergency departments, to reduce overdose risk. However, there are limitations in their detection capabilities, particularly with certain fentanyl analogs, and no large-scale studies have fully evaluated their safety and effectiveness. ^{1 2 4 5 6}

Is it safe to use fentanyl test strips in humans?

The research does not provide specific safety data for fentanyl test strips, but they are widely used and supported by individuals with opioid dependence to detect fentanyl in drugs, suggesting they are generally considered safe for this purpose. ^{1 2 4 5 6}

Is using Fentanyl Test Strips a promising treatment for preventing opioid overdose?

Yes, Fentanyl Test Strips are promising because they help people detect fentanyl in drugs, which can prevent overdoses. They are supported by people who use opioids and can promote safer drug use. ^{1 2 3 4 7}

How do fentanyl test strips differ from other treatments for preventing opioid overdose?

Fentanyl test strips are unique because they allow individuals to test drugs for the presence of fentanyl before use, helping to prevent overdoses by identifying potentially dangerous substances. Unlike other treatments that may involve medication or therapy, these strips provide a direct way for users to check their drugs and make informed decisions. ^{1 2 3 4 7}

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

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

None (must meet inclusion criteria)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Fentanyl self-testing in a community-based sample of people who inject drugs, San Francisco. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Fentanyl Test Strip Use and Overdose History among Individuals on Medication for Opioid Use Disorder. [2022]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot testing fentanyl test strip distribution in an emergency department setting: Experiences, lessons learned, and suggestions from staff. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of fentanyl test strip distribution in two Mid-Atlantic syringe services programs. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

A pilot study assessing client understanding and use of fentanyl test strips for harm reduction. [2023]