The Rhode Island Prescription and Illicit Drug Study

NCT04372238 | Completed Results DMC

• 2 other identifiers: 1904002388R01DA047975
• Study Type: interventional
• Target: 509
• Locations: 1 country
• Sites: 1

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)

Conditions

Opioid Overdose; Drug Overdose

Keywords

Drug overdose; Substance-Related Disorders; Chemically-induced disorders; Fentanyl; analgesics, Opioids; Narcotics; Naloxone; Central Nervous System Depressants; Physiological Effects of Drugs

Outcome Measures

Primary Outcomes (2)

• Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants

  A composite measure was created in order to be able to create a count of overdoses experienced at 6 or 12 months post baseline. This was from a combination of sefl-reported data, and administrative data.

  12 months post-randomization

• Accidental Non-fatal Overdose in the Past Month

  At each visit, we asked participants a yes or no question as to whether they experienced an overdose in the last month. This self-reported outcome was creating by taking the number of people who reported an overdose at a given time increment and dividing it by the total number of visits completed at that time increment. We did this for each arm. So for example, at month 1, the calculation would have been \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]

  12 months post-randomization

Secondary Outcomes (2)

• The Number of Fatal Overdose Events

  12 months post-randomization

• Number of Participants With Positive Dry Blood Spot Samples

  12 months post randomization

Study Arms (2)

RAPIDS intervention

EXPERIMENTAL

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; Behavioral: Standard OEND

Standard OEND

ACTIVE COMPARATOR

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

Behavioral: Standard OEND

Interventions

RAPIDS Intervention BEHAVIORAL

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

RAPIDS intervention

Standard OEND 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.

RAPIDS intervention; Standard OEND

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

• 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.

  PMID: 30344005 BACKGROUND

• Jacka BP, Goldman JE, Yedinak JL, Bernstein E, Hadland SE, Buxton JA, Sherman SG, Biello KB, Marshall BDL. A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial. Trials. 2020 Nov 26;21(1):976. doi: 10.1186/s13063-020-04898-8.

  PMID: 33243291 DERIVED

MeSH Terms

Conditions

Opiate Overdose; Drug Overdose; Substance-Related Disorders; Chemically-Induced Disorders

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Results Point of Contact

• Title: Brandon DL Marshall, PhD
• Organization: Brown University School of Public Health

brandon_marshall@brown.edu

4018636427

Study Officials

• Brandon DL Marshall, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: May 1, 2020
• Study Start: August 31, 2020
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)