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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

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).

Condition or disease Intervention/treatment Phase
Accidental Overdose of Opiate Behavioral: Take home rapid drug test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
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
Official Title: Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine


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.
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

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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373825


Locations
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United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Brandon DL Marshall, PhD Brown University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03373825     History of Changes
Other Study ID Numbers: 1612001662
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brown University:
overdose prevention
opioid overdose
risk behavior
harm reduction

Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics