Clinical trial NCT03373825: Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
Official title: Rapid Self-Testing to Prevent Fentanyl Overdose Among Young People Who Use Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Overdose of Opiate
Keywords: overdose prevention
opioid overdose
risk behavior
harm reduction
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either ARM1 or ARM2 depending on when they enrolled in the study.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Willingness to use the take-home rapid drug test
timeFrame: At 2 week follow-up
Secondary outcomes:
measure: Current overdose prevention behaviors
timeFrame: At baseline enrollment
measure: Number of take-home rapid drug tests conducted
timeFrame: At 2 week follow-up
measure: Change in overdose prevention behaviors
timeFrame: At 2 week follow-up
measure: Recent non-prescription fentanyl exposure
timeFrame: At baseline enrollment
measure: Recent non-prescription fentanyl exposure
timeFrame: At 2 week follow-up.
measure: Prevalence of take home drug tests reporting the presence of fentanyl exposure
timeFrame: At 2 week follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Brandon DL Marshall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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
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.