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

Accidental Overdose of Opiate Clinical Trial

— RAPiDS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373825
• Other study ID #: 1612001662
• Status: Completed
• Phase: N/A
• First received: December 6, 2017
• Last updated: January 23, 2018
• Start date: May 15, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: January 2018
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 15, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Accidental Overdose of Opiate
• Drug Overdose

Intervention

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).

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At 2 week follow-up
Secondary	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).	At baseline enrollment
Secondary	Number of take-home rapid drug tests conducted	Self-reported number of take home rapid drug tests used by participant (Arm1 vs Arm2).	At 2 week follow-up
Secondary	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).	At 2 week follow-up
Secondary	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).	At baseline enrollment
Secondary	Recent non-prescription fentanyl exposure	Self-reported measure from take home rapid drug test results (any positive result).	At 2 week follow-up.
Secondary	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.	At 2 week follow-up