RAPIDS: The Rhode Island Prescription and Illicit Drug Study

Sponsor

Brown University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04372238

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Opioid Overdose Drug Overdose	Behavioral: RAPIDS Intervention Behavioral: Standard OEND	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Investigator, Outcomes Assessor)

Masking Description:

The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments. Additionally, the principal investigator will remain blinded to the randomization.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 31, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: RAPIDS Intervention

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

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.

Active Comparator: Standard OEND

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

Behavioral: Standard OEND

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The number of fatal overdose events [12 months post-randomization]
The number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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