Trial Outcomes & Findings for The Rhode Island Prescription and Illicit Drug Study (NCT NCT04372238)
NCT ID: NCT04372238
Last Updated: 2025-08-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
509 participants
Primary outcome timeframe
12 months post-randomization
Results posted on
2025-08-24
Participant Flow
Participants were recruited through flyers, bus advertisements, through word of mouth or directly from syringe services providers. Study visits happened at three locations, two of which were drop in sites within syringe services programs and the other was our study office.
There were a number of participants who left during the baseline visits, largely due to needing to get to another appointment, and therefore did not receive allocation.
Participant milestones
| Measure |
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.
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.
|
Standard OEND
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
255
|
|
Overall Study
COMPLETED
|
245
|
242
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
| Measure |
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.
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.
|
Standard OEND
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
Overall Study
Duplicate
|
3
|
3
|
|
Overall Study
Did not consent for data linkage
|
6
|
10
|
Baseline Characteristics
A number of our participants refused to answer this question in a way presented in the table below
Baseline characteristics by cohort
| Measure |
RAPIDS Intervention
n=245 Participants
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.
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.
|
Standard OEND
n=242 Participants
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
Total
n=487 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
n=245 Participants
|
44 years
n=242 Participants
|
43 years
n=487 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=243 Participants • A number of our participants refused to answer this question in a way presented in the table below
|
85 Participants
n=233 Participants • A number of our participants refused to answer this question in a way presented in the table below
|
166 Participants
n=476 Participants • A number of our participants refused to answer this question in a way presented in the table below
|
|
Sex: Female, Male
Male
|
162 Participants
n=243 Participants • A number of our participants refused to answer this question in a way presented in the table below
|
148 Participants
n=233 Participants • A number of our participants refused to answer this question in a way presented in the table below
|
310 Participants
n=476 Participants • A number of our participants refused to answer this question in a way presented in the table below
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
135 Participants
n=245 Participants
|
116 Participants
n=242 Participants
|
251 Participants
n=487 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
33 Participants
n=245 Participants
|
44 Participants
n=242 Participants
|
77 Participants
n=487 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Multiracial
|
29 Participants
n=245 Participants
|
26 Participants
n=242 Participants
|
55 Participants
n=487 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latine
|
47 Participants
n=245 Participants
|
55 Participants
n=242 Participants
|
102 Participants
n=487 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=245 Participants
|
1 Participants
n=242 Participants
|
2 Participants
n=487 Participants
|
|
Self-reported non fatal overdose
|
15 Participants
n=245 Participants
|
12 Participants
n=242 Participants
|
27 Participants
n=487 Participants
|
|
One or more EMS runs for suspected opioid overdose
|
22 Participants
n=245 Participants
|
27 Participants
n=242 Participants
|
49 Participants
n=487 Participants
|
|
One or more emergency department encounters for non-fatal overdose
|
18 Participants
n=245 Participants
|
28 Participants
n=242 Participants
|
46 Participants
n=487 Participants
|
PRIMARY outcome
Timeframe: 12 months post-randomizationA 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.
Outcome measures
| Measure |
RAPIDS Intervention
n=245 Participants
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.
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.
|
Standard OEND
n=242 Participants
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants
|
48 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: 12 months post-randomizationAt 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 \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]
Outcome measures
| Measure |
RAPIDS Intervention
n=245 Participants
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.
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.
|
Standard OEND
n=242 Participants
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
Accidental Non-fatal Overdose in the Past Month
Month 1
|
5.4 Overdoses per 100 study visits
|
2.7 Overdoses per 100 study visits
|
|
Accidental Non-fatal Overdose in the Past Month
Month 2
|
5.6 Overdoses per 100 study visits
|
4.6 Overdoses per 100 study visits
|
|
Accidental Non-fatal Overdose in the Past Month
Month 3
|
3.4 Overdoses per 100 study visits
|
4.0 Overdoses per 100 study visits
|
|
Accidental Non-fatal Overdose in the Past Month
Month 6
|
10.6 Overdoses per 100 study visits
|
4.3 Overdoses per 100 study visits
|
|
Accidental Non-fatal Overdose in the Past Month
Month 12
|
5.3 Overdoses per 100 study visits
|
11.7 Overdoses per 100 study visits
|
SECONDARY outcome
Timeframe: 12 months post-randomizationThe number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data
Outcome measures
| Measure |
RAPIDS Intervention
n=245 Participants
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.
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.
|
Standard OEND
n=242 Participants
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
The Number of Fatal Overdose Events
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 months post randomizationAs part of the dry blood spot supplement, we gathered dry blood spots from participants at baseline and 6 and 12 months post randomization. This outcome assess how many participants in each arm had a positive fentanyl sample. Because of protocols at Brown University related to biosafety, we were only able to collect dry blood spots from participants who we met with at our study offices. We could not get samples from those who we recruited from SSPs
Outcome measures
| Measure |
RAPIDS Intervention
n=245 Participants
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.
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.
|
Standard OEND
n=242 Participants
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
Number of Participants With Positive Dry Blood Spot Samples
Positive
|
34 Participants
|
35 Participants
|
|
Number of Participants With Positive Dry Blood Spot Samples
Negative
|
86 Participants
|
79 Participants
|
|
Number of Participants With Positive Dry Blood Spot Samples
Not assessed
|
125 Participants
|
128 Participants
|
Adverse Events
RAPIDS Intervention
Serious events: 15 serious events
Other events: 0 other events
Deaths: 9 deaths
Standard OEND
Serious events: 12 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
RAPIDS Intervention
n=245 participants at risk
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.
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.
|
Standard OEND
n=242 participants at risk
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Non-fatal overdose
|
6.1%
15/245 • Number of events 15 • Each participant was assessed for all adverse events at an on-going basis for up to 15 months following enrollment.
Severe adverse event data were reported to the IRB and DSMB within 48 hours of occurring, and non-severe adverse events were reported annually.
|
5.0%
12/242 • Number of events 245 • Each participant was assessed for all adverse events at an on-going basis for up to 15 months following enrollment.
Severe adverse event data were reported to the IRB and DSMB within 48 hours of occurring, and non-severe adverse events were reported annually.
|
Other adverse events
Adverse event data not reported
Additional Information
Brandon DL Marshall, PhD
Brown University School of Public Health
Phone: 4018636427
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place