Opioid OverdoseRAPIDSNCT04372238
The Rhode Island Prescription and Illicit Drug Study
A study testing RAPIDS Intervention and Standard OEND in people with Opioid Overdose and Drug Overdose, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose, Drug Overdose
- What is being tested?
- RAPIDS Intervention and Standard OEND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: The Rhode Island Prescription and Illicit Drug Study Responding to Fentanyl and Associated Harms
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)
Read the 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.
- Conditions
- Opioid Overdose, Drug Overdose
- Being tested
- RAPIDS Intervention, Standard OEND
- Keywords
- Drug overdose, Substance-Related Disorders, Chemically-induced disorders, Fentanyl, analgesics, Opioids, Narcotics, Naloxone, Central Nervous System Depressants, Physiological Effects of Drugs
- Medical subject headings
- Opiate Overdose, Drug Overdose, Substance-Related Disorders, Chemically-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAPIDS InterventionBehavioural
RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.
Standard OENDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: RAPIDS Intervention; Behavioral: Standard OEND |
| Standard OEND | Active comparator | In the control arm participants will receive standard overdose education and naloxone distribution (OEND). Receives: Behavioral: Standard OEND |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Measured: 12 months post-randomization
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start31 Aug 2020
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Brandon DL Marshall, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372238
- Sponsor's protocol ID
- 1904002388
- Other IDs
- R01DA047975
- Acronym
- RAPIDS
- Status last verified
- Jul 2025
- First submitted
- 2 Mar 2020
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30344005Jacka 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.
PubMed 33243291
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rhode Island Prescription and Illicit Drug Study Responding to Fentanyl and Associated Harms
- ClinicalTrials.gov ID
- NCT04372238
- Acronym / sponsor ID
- RAPIDS / 1904002388
- Conditions
- Opioid Overdose, Drug Overdose
- Keywords
- Drug overdose, Substance-Related Disorders, Chemically-induced disorders, Fentanyl, analgesics, Opioids, Narcotics, Naloxone, Central Nervous System Depressants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RAPIDS intervention | Experimental | Behavioral: RAPIDS Intervention, Behavioral: Standard OENDParticipants 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. |
| Standard OEND | Active comparator | Behavioral: Standard OENDIn the control arm participants will receive standard overdose education and naloxone distribution (OEND). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAPIDS InterventionRAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips. | Behavioural | RAPIDS intervention |
| Standard OENDIn 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. | Behavioural | RAPIDS intervention, Standard OEND |
Primary outcome
Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants
Time frame: 12 months post-randomization
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.
Accidental Non-fatal Overdose in the Past Month
Time frame: 12 months post-randomization
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]
2 secondary outcomes
The Number of Fatal Overdose Events
Time frame: 12 months post-randomization
Number of Participants With Positive Dry Blood Spot Samples
Time frame: 12 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30344005Krieger 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.
- Derived from this study: PubMed 33243291Jacka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon DL Marshall, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAPIDS Intervention and Standard OEND in people with Opioid Overdose and Drug Overdose, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants (time frame: 12 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.