Drug Overdose, Opioid Overdose
Conditions
Keywords
Drug overdose, Substance-Related Disorders, Chemically-induced disorders, Fentanyl, analgesics, Opioids, Narcotics, Naloxone, Central Nervous System Depressants, Physiological Effects of Drugs
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)
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.
Interventions
BEHAVIORALRAPIDS Intervention
RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.
BEHAVIORALStandard 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The biostatistician will be blinded to the intervention/control group assignment throughout the course of the study and the assignments.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants | 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 | 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 \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Fatal Overdose Events | 12 months post-randomization | The number of fatal overdoses experienced throughout 12 month enrollment in the study, measured using Rhode Island Department of Health data |
| Number of Participants With Positive Dry Blood Spot Samples | 12 months post randomization | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 245 |
| 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. | 242 |
| Total | 487 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not consent for data linkage | 6 | 10 |
| Overall Study | Duplicate | 3 | 3 |
Baseline characteristics
| Characteristic | RAPIDS Intervention | Standard OEND | Total |
|---|---|---|---|
| Age, Continuous | 41 years | 44 years | 43 years |
| One or more emergency department encounters for non-fatal overdose | 18 Participants | 28 Participants | 46 Participants |
| One or more EMS runs for suspected opioid overdose | 22 Participants | 27 Participants | 49 Participants |
| Race/Ethnicity, Customized Hispanic/Latine | 47 Participants | 55 Participants | 102 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 33 Participants | 44 Participants | 77 Participants |
| Race/Ethnicity, Customized Non-Hispanic Multiracial | 29 Participants | 26 Participants | 55 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 135 Participants | 116 Participants | 251 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 2 Participants |
| Self-reported non fatal overdose | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Female | 81 Participants | 85 Participants | 166 Participants |
| Sex: Female, Male Male | 162 Participants | 148 Participants | 310 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 245 | 7 / 242 |
| other Total, other adverse events | 0 / 245 | 0 / 242 |
| serious Total, serious adverse events | 15 / 245 | 12 / 242 |
Outcome results
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 \[number of intervention participants reporting an overdose at baseline\]/\[total visits completed by intervention participants at month 1\]
Time frame: 12 months post-randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RAPIDS Intervention | Accidental Non-fatal Overdose in the Past Month | Month 12 | 5.3 Overdoses per 100 study visits |
| RAPIDS Intervention | Accidental Non-fatal Overdose in the Past Month | Month 1 | 5.4 Overdoses per 100 study visits |
| RAPIDS Intervention | Accidental Non-fatal Overdose in the Past Month | Month 3 | 3.4 Overdoses per 100 study visits |
| RAPIDS Intervention | Accidental Non-fatal Overdose in the Past Month | Month 6 | 10.6 Overdoses per 100 study visits |
| RAPIDS Intervention | Accidental Non-fatal Overdose in the Past Month | Month 2 | 5.6 Overdoses per 100 study visits |
| Standard OEND | Accidental Non-fatal Overdose in the Past Month | Month 6 | 4.3 Overdoses per 100 study visits |
| Standard OEND | Accidental Non-fatal Overdose in the Past Month | Month 12 | 11.7 Overdoses per 100 study visits |
| Standard OEND | Accidental Non-fatal Overdose in the Past Month | Month 3 | 4.0 Overdoses per 100 study visits |
| Standard OEND | Accidental Non-fatal Overdose in the Past Month | Month 1 | 2.7 Overdoses per 100 study visits |
| Standard OEND | Accidental Non-fatal Overdose in the Past Month | Month 2 | 4.6 Overdoses per 100 study visits |
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.
Time frame: 12 months post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAPIDS Intervention | Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants | 48 Participants |
| Standard OEND | Number of People Identified Has Having One or More Overdose Among RAPIDS Trial Participants | 36 Participants |
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
Time frame: 12 months post randomization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RAPIDS Intervention | Number of Participants With Positive Dry Blood Spot Samples | Positive | 34 Participants |
| RAPIDS Intervention | Number of Participants With Positive Dry Blood Spot Samples | Negative | 86 Participants |
| RAPIDS Intervention | Number of Participants With Positive Dry Blood Spot Samples | Not assessed | 125 Participants |
| Standard OEND | Number of Participants With Positive Dry Blood Spot Samples | Positive | 35 Participants |
| Standard OEND | Number of Participants With Positive Dry Blood Spot Samples | Negative | 79 Participants |
| Standard OEND | Number of Participants With Positive Dry Blood Spot Samples | Not assessed | 128 Participants |
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
Time frame: 12 months post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RAPIDS Intervention | The Number of Fatal Overdose Events | 9 Participants |
| Standard OEND | The Number of Fatal Overdose Events | 7 Participants |