Fentanyl Test Strips for Opioid Overdose

Overseen By Emma S Kay, PhD, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Living in prison

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of fentanyl test strips in preventing drug overdoses by enabling individuals to detect fentanyl in their substances. Participants may receive the test strips, education on their use, or both, and the study will compare which approach most effectively reduces overdoses. It is ideal for individuals who have recently used illicit opioids or stimulants and reside in states where these test strips are legal. The trial also examines whether providing these resources by mail effectively helps more people avoid overdoses. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could save lives.

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

The trial information does not specify whether you need to stop taking your current medications. It focuses on the use of fentanyl test strips and education to prevent drug overdose.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fentanyl test strips are a safe tool for checking drugs for fentanyl. These strips, small pieces of paper, can detect fentanyl in various drugs. They are already legal in some places, like Rhode Island, indicating their safety for public use.

Studies have found that using fentanyl test strips helps people take steps to lower the risk of overdose, making them a valuable tool for reducing harm. Importantly, no known safety concerns or negative effects arise from using these strips.

Fentanyl test strip education teaches people how to use these strips safely and effectively. This education empowers users to make informed choices to prevent overdose. Overall, both the strips and the education about them are seen as safe and helpful ways to reduce the risk of opioid overdose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fentanyl test strips (FTS) for opioid overdose prevention because they offer a proactive approach to harm reduction. Unlike traditional methods that primarily focus on treating overdoses after they occur, like administering naloxone, FTS allow individuals to test substances for the presence of fentanyl before use, potentially preventing an overdose from happening in the first place. This approach empowers users with knowledge and encourages safer choices, which could significantly reduce the risk of accidental overdoses. Additionally, the educational component provided with FTS can enhance awareness and understanding, making this method an innovative step forward in combating the opioid crisis.

What evidence suggests that this trial's treatments could be effective in reducing opioid overdose rates?

Studies have shown that fentanyl test strips (FTS) can help prevent opioid overdoses. Research indicates that 43% of users changed their drug use after using FTS, and 77% felt safer from overdose risks. These strips accurately detect fentanyl in street drugs, making them a reliable way to reduce harm. Young adults have reported a willingness to use FTS, supporting their effectiveness in real-life situations. In this trial, some participants will receive both FTS distribution and education, while others will receive only FTS distribution, only education, or a referral list. Education about FTS enhances their impact by teaching users how to use the strips to prevent overdoses. Overall, FTS and education about them are promising ways to lower the risk of overdose among people who use drugs. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals struggling with opiate dependence or who are at risk of opioid overdose. The study aims to help participants by providing fentanyl test strips and education on their use, remotely. Specific eligibility criteria details were not provided.

Inclusion Criteria

Report using illicit opioids and/or stimulants (including counterfeit pills) within the past 3 months per the ASSIST

Be able and willing to provide the names and contact information of three close contacts to reach if the participant cannot be reached

I can speak and read English.

Exclusion Criteria

Living in a restricted environment (e.g., prison)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase

Adapting and piloting the interventions with 100 participants, assessing feasibility, acceptability, and appropriateness

3 months

R33 Phase

Fully powered trial to compare overdose outcomes among 2,952 participants randomized to four study arms

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl test strip education
• Fentanyl test strips

Trial Overview The trial tests whether mailing out fentanyl test strips and providing education can reduce overdoses among drug users. It's a first-of-its-kind national study using a unique design to see which method (test strip distribution alone or combined with education) is more effective.

How Is the Trial Designed?

Group I: FDE Experimental Treatment 2 Interventions

This arm receives both FTS distribution (FTS delivered to their residential address) and education (FDE), as well as a resource list for naloxone and additional FTS if desired.

Group II: FD Experimental Treatment 1 Intervention

The FTS distribution only (FDE) arm receives FTS delivered to their residential address as well as a resource list for obtaining naloxone and additional FTS, if desired.

Group III: E Experimental Treatment 1 Intervention

The Education only (E) arm receives FTS education as well as a resource list for obtaining naloxone and FTS.

Group IV: R Active Control 1 Intervention

The referral only (R) arm receives a resource list for obtaining naloxone and FTS.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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. 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, ...

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. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08440-y

Evaluating fentanyl test strips as a harm reduction strategy in ... This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs.

5. 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.

6. portal.ct.gov portal.ct.gov/dph/health-education-management--surveillance/the-office-of-injury-prevention/opioids-and-prescription-drug-overdose-prevention-program

Opioids and Drug Overdose Prevention Program Fentanyl test strips are a tool that can be used to prevent an opioid overdose. ... Watch the fentanyl test strip video to learn the proper steps to test for ...

7. 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 ...

8. vdh.virginia.gov vdh.virginia.gov/overdose-prevention/

Virginia Overdose Prevention Resources Fentanyl test strips can tell you if there is fentanyl in something that you are using. The test strip will not tell you the amount of fentanyl ...