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Completed

NCT Number: NCT03373825

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

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).

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Key information

Conditions

Accidental Overdose of Opiate Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Harm Reduction Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Prescription Drug Misuse Risk-Taking Substance-Related Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Take home rapid drug test

Behavioral

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).

Other names: Rapid Response fentanyl test strips

Primary outcomes

  1. Willingness to use the take-home rapid drug test

    Time frame: At 2 week follow-up

    Self-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 outcomes

  1. Current overdose prevention behaviors

    Time frame: At baseline enrollment

    Self-reported steps taken to avoid accidental overdose, measured by a "check all that apply" survey question (what they do to avoid an accidental overdose).

  2. Number of take-home rapid drug tests conducted

    Time frame: At 2 week follow-up

    Self-reported number of take home rapid drug tests used by participant (Arm1 vs Arm2).

  3. Change in overdose prevention behaviors

    Time frame: At 2 week follow-up

    Self-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).

  4. Recent non-prescription fentanyl exposure

    Time frame: At baseline enrollment

    Self-reported from personal experience (belief that they had ever been exposed to fentanyl), measured by Likert-Scale survey question (Strongly Agree--Strongly Disagree).

  5. Recent non-prescription fentanyl exposure

    Time frame: At 2 week follow-up.

    Self-reported measure from take home rapid drug test results (any positive result).

  6. Prevalence of take home drug tests reporting the presence of fentanyl exposure

    Time frame: At 2 week follow-up

    Self-reported measure of the number of times they received a positive rapid drug test result.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Acronym: RAPiDS2

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 14, 2017
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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