The Rhode Island Prescription and Illicit Drug Study

Opioid Overdose Clinical Trial

— RAPIDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372238
• Other study ID #: 1904002388
• Secondary ID: R01DA047975
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

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

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Krieger MS, Goedel WC, Buxton JA, Lysyshyn M, Bernstein E, Sherman SG, Rich JD, Hadland SE, Green TC, Marshall BDL. Use of rapid fentanyl test strips among young adults who use drugs. Int J Drug Policy. 2018 Nov;61:52-58. doi: 10.1016/j.drugpo.2018.09.009. Epub 2018 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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