Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs (RAPiDS2)

January 23, 2018 updated by: Brown University
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).

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
50 participants will receive a kit containing 10 Rapid Response fentanyl test strips. We will ask participants to use the take-home rapid drug test to test their urine for presence or absence of fentanyl.
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
Experimental: Arm 2
50 participants will receive a kit containing 10 Rapid Response fentanyl test strips. We will ask the participants to use the take-home rapid drug test to test the residue of their drug (ie. instruct them to test bags, cookers, spoons, etc.) for the presence or absence of fentanyl.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At 2 week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline enrollment
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).
At 2 week follow-up
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).
At 2 week follow-up
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).
At baseline enrollment
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).
At 2 week follow-up.
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.
At 2 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

October 18, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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