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Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs

Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03373825
Acronym
RAPiDS2
Enrollment
93
Registered
2017-12-14
Start date
2017-05-15
Completion date
2017-12-15
Last updated
2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Overdose of Opiate

Keywords

overdose prevention, opioid overdose, risk behavior, harm reduction

Brief summary

The research team will enroll 100 young adults who use cocaine, heroin, inject drugs, or purchase prescription medications on the illicit market in a pilot study to be known as the Rhode Island Young Adult Prescription and Illicit Drug Study (RAPIDS). Participants will be trained to use a take-home home rapid drug test to test for the presence or absence of fentanyl in their drug supply. Half of the enrolled participants will be asked to test their urine for presence or absence of fentanyl, and the other half will be asked to test their drug residue for presence or absence of fentanyl. All participants will receive up to 15 take-home rapid drug tests for fentanyl. A follow-up survey will examine and compare utilization of the tests between the two groups. The study will be guided by the information-motivation-behavioral skills (IMB) model of engagement in health behaviors. The IMB model hypothesizes that if a person possesses the information, motivation, and behavioral skills to act, there is an increased likelihood that she/he will fulfill and maintain the desired behaviors (behaviors that will reduce accidental overdose).

Detailed description

The research team will administer a brief survey to ascertain behavioral, psychosocial, and clinical factors that may be related to non-prescription fentanyl (NPF) exposure among young people who use illicit drugs. The researchers will also characterize knowledge of and perceptions towards drugs contaminated with NPF, as well as the potential diversion of prescription fentanyl formulations (e.g., transdermal patches). After the interviewer-administered survey has been completed, participants will provide urine samples to determine recent exposure to NPF and other illicit drugs. The research team will assess the acceptability and feasibility of take home rapid drug tests to test for fentanyl exposure among 100 participants from the target population. After the enrollment and baseline survey, participants will be provided with rapid drug tests that detect the presence or absence of fentanyl in their drug supply. Half the participants will be asked to test their urine to see if they have been exposed to a fentanyl-contaminated drug. The other half will be asked to test the residue of the drug that they intend to use. Study participants will then be asked to return in 2 weeks for a brief follow-up survey that will assess whether they used the self-tests, whether the technology was acceptable and easy to use, and whether and how a positive test result altered their drug-using and overdose prevention behaviors.

Interventions

BEHAVIORALTake home rapid drug test

The Rapid Response fentanyl test strips will be offered as take-home rapid drug tests to all participants to assess the willingness to use take-home rapid drug tests and the feasibility of using such an intervention at home. Arm 1 will be offered one method of using the take-home rapid drug test (urine testing). Arm 2 will be offered a second method of using the take-home rapid drug test (testing drug residue).

Sponsors

Brown University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Masking description

Participants in ARM1 were only aware of the use of the Take home rapid drug test as a urine test. Participants in ARM2, while instructed to test their drug residue, were aware of the ability to use the take home rapid drug test as a urine test.

Intervention model description

Participants will be assigned to either ARM1 or ARM2 depending on when they enrolled in the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-35 years of age * resident of Rhode Island * able to complete interviews in English * self-reported heroin, cocaine, injection drug use, or counterfeit prescription pill use in the past 30 days

Exclusion criteria

-participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

Design outcomes

Primary

MeasureTime frameDescription
Willingness to use the take-home rapid drug testAt 2 week follow-upSelf-reported measure of willingness to use take-home rapid drug tests (compare Arm1 and Arm2), measured by response to Likert-scale survey question (Strongly Agree--Strongly Disagree).

Secondary

MeasureTime frameDescription
Current overdose prevention behaviorsAt baseline enrollmentSelf-reported steps taken to avoid accidental overdose, measured by a check all that apply survey question (what they do to avoid an accidental overdose).
Number of take-home rapid drug tests conductedAt 2 week follow-upSelf-reported number of take home rapid drug tests used by participant (Arm1 vs Arm2).
Change in overdose prevention behaviorsAt 2 week follow-upSelf-reported actions taken in response to the take home rapid drug test results, measured by a check all that apply survey question (what they did after they found out the drugs were laced with fentanyl).
Recent non-prescription fentanyl exposureAt baseline enrollmentSelf-reported from personal experience (belief that they had ever been exposed to fentanyl), measured by Likert-Scale survey question (Strongly Agree--Strongly Disagree).
Prevalence of take home drug tests reporting the presence of fentanyl exposureAt 2 week follow-upSelf-reported measure of the number of times they received a positive rapid drug test result.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026