The Rhode Island Prescription and Illicit Drug Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2024-02-29

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Opioid Overdose Drug Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to receive the RAPIDS intervention will receive fentanyl test strips and additional fentanyl-specific education. Both arms will receive standardized overdose prevention education and naloxone.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments.

Study Groups

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RAPIDS intervention

Participants randomized to receive the RAPIDS intervention will receive a fentanyl specific behavioral intervention and a brief behavioral intervention to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, in addition to standard OEND.

Group Type EXPERIMENTAL

RAPIDS Intervention

Intervention Type BEHAVIORAL

RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.

Standard OEND

Intervention Type BEHAVIORAL

In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3 months. Participants will receive a naloxone kit after completion of the first session, and information regarding where to obtain additional naloxone at subsequent visits. They will have contact with study staff at month 6 and 12 follow-up visits to capture outcome and covariate data.

Standard OEND

In the control arm participants will receive standard overdose education and naloxone distribution (OEND).

Group Type ACTIVE_COMPARATOR

Standard OEND

Intervention Type BEHAVIORAL

In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3 months. Participants will receive a naloxone kit after completion of the first session, and information regarding where to obtain additional naloxone at subsequent visits. They will have contact with study staff at month 6 and 12 follow-up visits to capture outcome and covariate data.

Interventions

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RAPIDS Intervention

RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.

Intervention Type BEHAVIORAL

Standard OEND

In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3 months. Participants will receive a naloxone kit after completion of the first session, and information regarding where to obtain additional naloxone at subsequent visits. They will have contact with study staff at month 6 and 12 follow-up visits to capture outcome and covariate data.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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