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

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ClinicalTrials.gov Identifier: NCT03373825
Recruitment Status : Completed
First Posted : December 14, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Brown University

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE December 14, 2017
Last Update Posted Date January 24, 2018
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date October 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03373825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
Official Title  ICMJE Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be assigned to either ARM1 or ARM2 depending on when they enrolled in the study.
Masking: Single (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.
Primary Purpose: Screening
Condition  ICMJE Accidental Overdose of Opiate
Intervention  ICMJE Behavioral: Take 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).
Other Name: Rapid Response fentanyl test strips
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Take home rapid drug test
  • 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.
    Intervention: Behavioral: Take home rapid drug test
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2017)
93
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2017
Actual Primary Completion Date October 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03373825
Other Study ID Numbers  ICMJE 1612001662
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brandon DL Marshall, PhD Brown University
PRS Account Brown University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP