- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373825
Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs (RAPiDS2)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Publications and helpful links
General Publications
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Drug Overdose
- Opiate Overdose
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- 1612001662
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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