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

NCT ID: NCT03373825

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2017-12-15

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.

Conditions

Accidental Overdose of Opiate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Take home rapid drug test

Intervention Type: BEHAVIORAL

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).

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.

Group Type: EXPERIMENTAL

Take home rapid drug test

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Rapid Response fentanyl test strips

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brandon DL Marshall, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26577516 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 30621699 (View on PubMed)

Other Identifiers

1612001662

Identifier Type: -

Identifier Source: org_study_id