The Rhode Island Prescription and Illicit Drug Study

  • STATUS
    Recruiting
  • participants needed
    500
  • sponsor
    Brown University
Updated on 19 February 2024
heroin
drugs of abuse
stimulants

Summary

This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of enrollment. The investigators will evaluate whether the incorporation of rapid fentanyl testing into a theory-driven overdose education and prevention intervention reduces rates of overdose compared to standard overdose education and naloxone distribution. Results from this study will significantly improve public health efforts to address the fentanyl overdose epidemic and reduce harms associated with exposure to drugs contaminated with fentanyl. This is a full clinical trial, building on the previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have recently been published.(Krieger et al., 2018)

Description

The investigators will assess the efficacy of the RAPIDS intervention on preventing overdose among PWUD. Participants will be randomized 1:1 to receive the RAPIDS intervention or the attention-matched control condition. Experimental arm participants will receive the RAPIDS intervention, which includes education about the dangers of illicitly manufactured fentanyl (IMF), motivational interviewing to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips, and opportunities to plan and role- play how to implement overdose risk reduction behaviors upon receipt of a positive or negative test result. In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training. All participants will attend additional study visits at months 1,2,3,6, and 12. The primary endpoint will be the rate of self-reported overdose over the follow-up period. Secondary endpoints (e.g., overdose death) will be ascertained by data linkage to statewide overdose surveillance databases.

The primary aims of this study are to: 1) Assess the efficacy of the RAPIDS intervention in reducing rates of overdose among people who use drugs; 2) Examine the degree to which reductions in rates of overdose are mediated by increases in information, motivation, behavioral skills, and self-efficacy regarding fentanyl, rapid fentanyl testing, and harm reduction practices; and 3) Explore whether there is heterogeneity of treatment effect related to key participant characteristics.

Details
Condition Drug abuse, substance abuse, drug overdose disorder, substance abuse, Opioid Overdose
Age 18years - 65years
Treatment RAPIDS Intervention, Standard OEND
Clinical Study IdentifierNCT04372238
SponsorBrown University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Reside in Rhode Island
Are able to complete interviews in English
Are able to provide informed consent
Self-report past 30 day heroin, illicit stimulants, counterfeit prescription pills, or injection drugs

Exclusion Criteria

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