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

NCT03373825 | Completed

• 1 other identifier: 1612001662
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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).

Conditions

Accidental Overdose of Opiate

Keywords

overdose prevention; opioid overdose; risk behavior; harm reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Current overdose prevention behaviors

  At baseline enrollment

• Number of take-home rapid drug tests conducted

  At 2 week follow-up

• Change in overdose prevention behaviors

  At 2 week follow-up

• Recent non-prescription fentanyl exposure

  At baseline enrollment

• Recent non-prescription fentanyl exposure

  At 2 week follow-up.

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Interventions

Take home rapid drug test 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).

Also known as: Rapid Response fentanyl test strips

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (3)

• 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.

  PMID: 26577516 BACKGROUND

• 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

  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.

  PMID: 30621699 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Risk-Taking; Harm Reduction

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders; Behavior

Study Officials

• Brandon DL Marshall, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to either ARM1 or ARM2 depending on when they enrolled in the study.

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 14, 2017
• Study Start: May 15, 2017
• Primary Completion: October 18, 2017
• Study Completion: December 15, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)