Trial Outcomes & Findings for User Acceptability of a Device-Based Opioid Overdose Intervention (NCT NCT04530591)
NCT ID: NCT04530591
Last Updated: 2021-07-07
Results Overview
We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview.
Recruitment status
COMPLETED
Target enrollment
97 participants
Primary outcome timeframe
Day 1
Results posted on
2021-07-07
Participant Flow
Participant milestones
| Measure |
Patient Participants
This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.
Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.
Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.
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|---|---|
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Overall Study
STARTED
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97
|
|
Overall Study
COMPLETED
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97
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
User Acceptability of a Device-Based Opioid Overdose Intervention
Baseline characteristics by cohort
| Measure |
Patient Participants
n=97 Participants
This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.
Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.
Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.
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|---|---|
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Age, Continuous
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41 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
|
Housing Status
Homeless
|
31 Participants
n=5 Participants
|
|
Housing Status
House
|
7 Participants
n=5 Participants
|
|
Housing Status
Apartment
|
8 Participants
n=5 Participants
|
|
Housing Status
Shelter
|
36 Participants
n=5 Participants
|
|
Housing Status
Unknown
|
15 Participants
n=5 Participants
|
|
Started After Injury/Surgery
Yes
|
46 Participants
n=5 Participants
|
|
Started After Injury/Surgery
No
|
51 Participants
n=5 Participants
|
|
Duration of Opioid Use
|
12 years
n=5 Participants
|
|
Opioid Use Frequency (Days per Week)
1
|
0 Participants
n=5 Participants
|
|
Opioid Use Frequency (Days per Week)
2-3
|
9 Participants
n=5 Participants
|
|
Opioid Use Frequency (Days per Week)
4-6
|
7 Participants
n=5 Participants
|
|
Opioid Use Frequency (Days per Week)
7
|
80 Participants
n=5 Participants
|
|
Opioid Use Frequency (Days per Week)
Unknown
|
1 Participants
n=5 Participants
|
|
Opioid Use Frequency (Uses per Day)
1
|
1 Participants
n=5 Participants
|
|
Opioid Use Frequency (Uses per Day)
2-3
|
21 Participants
n=5 Participants
|
|
Opioid Use Frequency (Uses per Day)
4-6
|
46 Participants
n=5 Participants
|
|
Opioid Use Frequency (Uses per Day)
7+
|
27 Participants
n=5 Participants
|
|
Opioid Use Frequency (Uses per Day)
Unknown
|
2 Participants
n=5 Participants
|
|
Been to an Inpatient Rehab
Yes
|
79 Participants
n=5 Participants
|
|
Been to an Inpatient Rehab
No
|
18 Participants
n=5 Participants
|
|
Used MOUD
Yes
|
84 Participants
n=5 Participants
|
|
Used MOUD
No
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13 Participants
n=5 Participants
|
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Perceived likelihood of bystander intervention in the event of an overdose
Likely
|
53 Participants
n=5 Participants
|
|
Perceived likelihood of bystander intervention in the event of an overdose
Unlikely
|
44 Participants
n=5 Participants
|
|
Friends/Family Who have Overdosed
Yes
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77 Participants
n=5 Participants
|
|
Friends/Family Who have Overdosed
No
|
20 Participants
n=5 Participants
|
|
Friends/Family Who have had Overdose Complications
Yes
|
56 Participants
n=5 Participants
|
|
Friends/Family Who have had Overdose Complications
No
|
41 Participants
n=5 Participants
|
|
Friends/Family Who have Died from Overdose
Yes
|
75 Participants
n=5 Participants
|
|
Friends/Family Who have Died from Overdose
No
|
22 Participants
n=5 Participants
|
|
Has Overdosed
Yes
|
69 Participants
n=5 Participants
|
|
Has Overdosed
No
|
28 Participants
n=5 Participants
|
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Number of Prior Overdoses
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3 Incidents
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Some participants did not answer all the questions or selected more than one answer
We aim to characterize the degree of need for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview.
Outcome measures
| Measure |
Patient Participants
n=91 Participants
This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.
Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.
Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.
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|---|---|
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Community Need for a Device-based Opioid Overdose Intervention
Likely
|
69 Participants
|
|
Community Need for a Device-based Opioid Overdose Intervention
Unlikely
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Some participants did not answer all the questions or selected more than one answer
We aim to characterize the functional and aesthetic preferences of the participant population for a device-based opioid overdose intervention. These were extracted from the participant survey questions as well as from the words, phrases, and sentences used by participants during the interview.
Outcome measures
| Measure |
Patient Participants
n=97 Participants
This group of participants will complete a survey about their opioid use history and their preferences for a device-based intervention. They will then participate in a semi-structured interview to provide feedback on non-functional, "looks-like" prototypes of such a device.
Survey: Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.
Interview: Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, "looks-like" prototypes of a naloxone delivery device.
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|---|---|
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Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear an ankle strap · Unlikely
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52 Participants
|
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Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that senses an overdose · Likely
|
70 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that senses an overdose · Unlikely
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26 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that indicates the wearer is at risk of an overdose · Likely
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66 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that indicates the wearer is at risk of an overdose · Unlikely
|
29 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that straps naloxone to the body for a bystander to administer · Likely
|
52 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that straps naloxone to the body for a bystander to administer · Unlikely
|
44 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that senses an overdose and administers naloxone if needed · Likely
|
64 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that senses an overdose and administers naloxone if needed · Unlikely
|
32 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that alerts medical first responders if needed · Likely
|
68 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that alerts medical first responders if needed · Unlikely
|
28 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that alerts bystanders if needed · Likely
|
60 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that alerts bystanders if needed · Unlikely
|
35 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that monitors vital signs · Likely
|
73 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
Likely to use a device that monitors vital signs · Unlikely
|
22 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a necklace · Likely
|
48 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a necklace · Unlikely
|
46 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a canula · Likely
|
12 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a canula · Unlikely
|
84 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a skin-patch on chest · Likely
|
42 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a skin-patch on chest · Unlikely
|
54 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a skin-patch on upper arm · Likely
|
53 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a skin-patch on upper arm · Unlikely
|
43 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a watch-appearing bracelet · Likely
|
72 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a watch-appearing bracelet · Unlikely
|
22 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a wrist bracelet · Likely
|
69 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a wrist bracelet · Unlikely
|
26 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a shoulder strap · Likely
|
21 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a shoulder strap · Unlikely
|
30 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a thigh strap · Likely
|
15 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a thigh strap · Unlikely
|
33 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a chest strap · Likely
|
22 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a chest strap · Unlikely
|
72 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear glasses · Likely
|
24 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear glasses · Unlikely
|
70 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a knee brace · Likely
|
16 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear a knee brace · Unlikely
|
32 Participants
|
|
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
For a device that sense overdose - likely to wear an ankle strap · Likely
|
44 Participants
|
Adverse Events
Patient Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jacob Brenner, Assistant Professor of Medicine
Hospital of the University of Pennsylvania
Phone: 215-662-2222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place