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

Primary Purpose

Accidental Overdose of Opiate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Take home rapid drug test
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Accidental Overdose of Opiate focused on measuring overdose prevention, opioid overdose, risk behavior, harm reduction

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Willingness to use the take-home rapid drug test
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 Outcome Measures

Current overdose prevention behaviors
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).
Number of take-home rapid drug tests conducted
Self-reported number of take home rapid drug tests used by participant (Arm1 vs Arm2).
Change in overdose prevention behaviors
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).
Recent non-prescription fentanyl exposure
Self-reported from personal experience (belief that they had ever been exposed to fentanyl), measured by Likert-Scale survey question (Strongly Agree--Strongly Disagree).
Recent non-prescription fentanyl exposure
Self-reported measure from take home rapid drug test results (any positive result).
Prevalence of take home drug tests reporting the presence of fentanyl exposure
Self-reported measure of the number of times they received a positive rapid drug test result.

Full Information

First Posted
December 6, 2017
Last Updated
January 23, 2018
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT03373825
Brief Title
Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
Acronym
RAPiDS2
Official Title
Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Overdose of Opiate
Keywords
overdose prevention, opioid overdose, risk behavior, harm reduction

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to either ARM1 or ARM2 depending on when they enrolled in the study.
Masking
Participant
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.
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Take home rapid drug test
Other Intervention Name(s)
Rapid Response fentanyl test strips
Intervention Description
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).
Primary Outcome Measure Information:
Title
Willingness to use the take-home rapid drug test
Description
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).
Time Frame
At 2 week follow-up
Secondary Outcome Measure Information:
Title
Current overdose prevention behaviors
Description
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).
Time Frame
At baseline enrollment
Title
Number of take-home rapid drug tests conducted
Description
Self-reported number of take home rapid drug tests used by participant (Arm1 vs Arm2).
Time Frame
At 2 week follow-up
Title
Change in overdose prevention behaviors
Description
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).
Time Frame
At 2 week follow-up
Title
Recent non-prescription fentanyl exposure
Description
Self-reported from personal experience (belief that they had ever been exposed to fentanyl), measured by Likert-Scale survey question (Strongly Agree--Strongly Disagree).
Time Frame
At baseline enrollment
Title
Recent non-prescription fentanyl exposure
Description
Self-reported measure from take home rapid drug test results (any positive result).
Time Frame
At 2 week follow-up.
Title
Prevalence of take home drug tests reporting the presence of fentanyl exposure
Description
Self-reported measure of the number of times they received a positive rapid drug test result.
Time Frame
At 2 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon DL Marshall, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26577516
Citation
Amlani A, McKee G, Khamis N, Raghukumar G, Tsang E, Buxton JA. Why the FUSS (Fentanyl Urine Screen Study)? A cross-sectional survey to characterize an emerging threat to people who use drugs in British Columbia, Canada. Harm Reduct J. 2015 Nov 14;12:54. doi: 10.1186/s12954-015-0088-4.
Results Reference
background
Citation
BTNX Inc. Rapid Reponse™ Multi-Drug Integrated Split Specimen Cup. 2016 [cited 2016 Sept 18]; Available from: http://www.btnx.com/Product.aspx?id=18240
Results Reference
background
PubMed Identifier
30621699
Citation
Goldman JE, Waye KM, Periera KA, Krieger MS, Yedinak JL, Marshall BDL. Perspectives on rapid fentanyl test strips as a harm reduction practice among young adults who use drugs: a qualitative study. Harm Reduct J. 2019 Jan 8;16(1):3. doi: 10.1186/s12954-018-0276-0.
Results Reference
derived

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

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