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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047975 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Standard OEND | Active Comparator | In the control arm participants will receive standard overdose education and naloxone distribution (OEND). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAPIDS Intervention | Behavioral | RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Positive Dry Blood Spot Samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon DL Marshall, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30344005 | Background | 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. | |
| 33243291 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 months post-randomization |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-fatal overdose | Injury, poisoning and procedural complications | SAE | Systematic Assessment | All self-reported non-fatal overdoses were considered to be sever adverse events for this trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon DL Marshall, PhD | Brown University School of Public Health | 4018636427 | brandon_marshall@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 13, 2021 | Jun 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2023 | Jun 27, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2021 | Jul 16, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| D062787 | Drug Overdose |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
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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.
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The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments.
| 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. |
|
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 |
| 12 months post randomization |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Not all of our participants reported sex. Some preferred to not answer the question. | A number of our participants refused to answer this question in a way presented in the table below | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Self-reported non fatal overdose | Count of Participants | Participants |
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| One or more EMS runs for suspected opioid overdose | Count of Participants | Participants |
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| One or more emergency department encounters for non-fatal overdose | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | 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] | Posted | Number | Overdoses per 100 study visits | 12 months post-randomization |
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| 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 | Posted | Count of Participants | Participants | 12 months post-randomization |
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|
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| Secondary | 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 | Posted | Count of Participants | Participants | 12 months post randomization |
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|
| 9 |
| 245 |
| 15 |
| 245 |
| 0 |
| 245 |
| EG001 | 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. | 7 | 242 | 12 | 242 | 0 | 242 |
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| D001523 | Mental Disorders |
| Month 3 |
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| Month 6 |
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| Month 12 |
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| Not assessed |
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