The Rhode Island Prescription and Illicit Drug Study

Study Overview
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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)

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.

Official Title
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The Rhode Island Prescription and Illicit Drug Study Responding to Fentanyl and Associated Harms

Conditions
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Opioid Overdose, Drug Overdose

Intervention / Treatment
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* Behavioral: RAPIDS Intervention
* Behavioral: Standard OEND


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAPIDS intervention<br>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. | Behavioral: RAPIDS Intervention<br>* RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.<br>Behavioral: Standard OEND<br>* 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.<br>|
| Active Comparator: Standard OEND<br>In the control arm participants will receive standard overdose education and naloxone distribution (OEND). | Behavioral: Standard OEND<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accidental non-fatal overdose in the past month | The rate of self-reported, non-fatal opioid related overdose, measured by survey questions at each follow up visit. | 6 months post-randomization | 
| Accidental non-fatal overdose in the past month | The rate of self-reported, non-fatal opioid related overdose, measured by survey questions at each follow up visit. | 12 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of fatal overdose events | The number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data | 12 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug overdose, Substance-Related Disorders, Chemically-induced disorders, Fentanyl, analgesics, Opioids, Narcotics, Naloxone, Central Nervous System Depressants, Physiological Effects of Drugs