An interventional study of RAPIDS Intervention and Standard OEND in Opioid Overdose and Drug Overdose, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
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)
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.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 509 is above the median of 184 across 48 interventional studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
In the control arm participants will receive standard overdose education and naloxone distribution (OEND).
Behavioral: Standard OEND
RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.
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
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.
Time frame: 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 \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]
Time frame: 12 months post-randomization
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
Time frame: 12 months post-randomization
Number of Participants With Positive Dry Blood Spot Samples
As 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
Time frame: 12 months post randomization
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.
| Milestone | RAPIDS Intervention | Standard OEND |
|---|---|---|
| Started | 254 | 255 |
| Completed | 245 | 242 |
| Not completed | 9 | 13 |
| Withdrew: Duplicate | 3 | 3 |
| Withdrew: Did not consent for data linkage | 6 | 10 |
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.
| Participants | RAPIDS Intervention | Standard OEND |
|---|---|---|
| Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants | 48 | 36 |
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 \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]
| Overdoses per 100 study visits | RAPIDS Intervention | Standard OEND |
|---|---|---|
| Month 1 | 5.4 | 2.7 |
| Month 2 | 5.6 | 4.6 |
| Month 3 | 3.4 | 4.0 |
| Month 6 | 10.6 | 4.3 |
| Month 12 | 5.3 | 11.7 |
The number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data
| Participants | RAPIDS Intervention | Standard OEND |
|---|---|---|
| The Number of Fatal Overdose Events | 9 | 7 |
As 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
| Participants | RAPIDS Intervention | Standard OEND |
|---|---|---|
| Positive | 34 | 35 |
| Negative | 86 | 79 |
| Not assessed | 125 | 128 |
Collected over Each participant was assessed for all adverse events at an on-going basis for up to 15 months following enrollment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RAPIDS Intervention | 9/245 (3.7%) | 15/245 (6.1%) | 0/245 (0%) |
| Standard OEND | 7/242 (2.9%) | 12/242 (5%) | 0/242 (0%) |
| Event | RAPIDS Intervention | Standard OEND |
|---|---|---|
| Non-fatal overdoseInjury, poisoning and procedural complications | 15/245 | 12/242 |
| Age, Continuous(years) | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Median | 41 (35 to 52) | 44 (34 to 54) | 43 (35 to 53) |
| Sex: Female, Male(Participants) | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Female | 81 | 85 | 166 |
| Male | 162 | 148 | 310 |
| Race/Ethnicity, Customized(Participants) | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Non-Hispanic White | 135 | 116 | 251 |
| Non-Hispanic Black | 33 | 44 | 77 |
| Non-Hispanic Multiracial | 29 | 26 | 55 |
| Hispanic/Latine | 47 | 55 | 102 |
| Unknown | 1 | 1 | 2 |
| Self-reported non fatal overdose(Participants) | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Count of participants | 15 | 12 | 27 |
| One or more EMS runs for suspected opioid overdose(Participants) | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Count of participants | 22 | 27 | 49 |
| One or more emergency department encounters for non-fatal overdose(Participants) | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Count of participants | 18 | 28 | 46 |
PDFs hosted by the registry, ClinicalTrials.gov.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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