Opioid Overdose, Opioid-use Disorder, Substance Use Disorders
Conditions
Keywords
Naloxone Delivery, Survey
Brief summary
This pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. The results of this one-time short questionnaire will inform development of a novel naloxone delivery device.
Detailed description
All opioid overdose related deaths can be prevented with the timely delivery of Naloxone. This study is a one-time, preliminary survey of participants with opioid use disorder to assess the need for, and community attitudes towards, a wearable device capable of autonomously detecting and responding to an opioid overdose. The results of this survey will be used to guide ongoing development of a de novo device. This study will be conducted over a 3 month period and survey participants from the Kensington Neighborhood in North Philadelphia.
Interventions
OTHERInterview
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.
OTHERSurvey
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.
Sponsors
University of Pennsylvania
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have used opioids for more than 3 months or will be having surgery where opioids will be administered * Able to provide informed consent * Moderate to severe chronic pain treated with opioids or recreational use
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Community Need for a Device-based Opioid Overdose Intervention | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| Total | 97 |
Baseline characteristics
| Characteristic | Patient Participants |
|---|---|
| Age, Continuous | 41 Years |
| Been to an Inpatient Rehab No | 18 Participants |
| Been to an Inpatient Rehab Yes | 79 Participants |
| Duration of Opioid Use | 12 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Friends/Family Who have Died from Overdose No | 22 Participants |
| Friends/Family Who have Died from Overdose Yes | 75 Participants |
| Friends/Family Who have had Overdose Complications No | 41 Participants |
| Friends/Family Who have had Overdose Complications Yes | 56 Participants |
| Friends/Family Who have Overdosed No | 20 Participants |
| Friends/Family Who have Overdosed Yes | 77 Participants |
| Has Overdosed No | 28 Participants |
| Has Overdosed Yes | 69 Participants |
| Housing Status Apartment | 8 Participants |
| Housing Status Homeless | 31 Participants |
| Housing Status House | 7 Participants |
| Housing Status Shelter | 36 Participants |
| Housing Status Unknown | 15 Participants |
| Number of Prior Overdoses | 3 Incidents |
| Opioid Use Frequency (Days per Week) 1 | 0 Participants |
| Opioid Use Frequency (Days per Week) 2-3 | 9 Participants |
| Opioid Use Frequency (Days per Week) 4-6 | 7 Participants |
| Opioid Use Frequency (Days per Week) 7 | 80 Participants |
| Opioid Use Frequency (Days per Week) Unknown | 1 Participants |
| Opioid Use Frequency (Uses per Day) 1 | 1 Participants |
| Opioid Use Frequency (Uses per Day) 2-3 | 21 Participants |
| Opioid Use Frequency (Uses per Day) 4-6 | 46 Participants |
| Opioid Use Frequency (Uses per Day) 7+ | 27 Participants |
| Opioid Use Frequency (Uses per Day) Unknown | 2 Participants |
| Perceived likelihood of bystander intervention in the event of an overdose Likely | 53 Participants |
| Perceived likelihood of bystander intervention in the event of an overdose Unlikely | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 57 Participants |
| Started After Injury/Surgery No | 51 Participants |
| Started After Injury/Surgery Yes | 46 Participants |
| Used MOUD No | 13 Participants |
| Used MOUD Yes | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 97 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Community Need for a Device-based Opioid Overdose Intervention
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.
Time frame: Day 1
Population: Some participants did not answer all the questions or selected more than one answer
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Participants | Community Need for a Device-based Opioid Overdose Intervention | Likely | 69 Participants |
| Patient Participants | Community Need for a Device-based Opioid Overdose Intervention | Unlikely | 22 Participants |
Secondary
Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention
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.
Time frame: Day 1
Population: Some participants did not answer all the questions or selected more than one answer
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Likely to use a device that senses an overdose | Likely | 70 Participants |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Likely to use a device that senses an overdose | Unlikely | 26 Participants |
| Patient 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 | 66 Participants |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Likely to use a device that alerts bystanders if needed | Likely | 60 Participants |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Likely to use a device that alerts bystanders if needed | Unlikely | 35 Participants |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Likely to use a device that monitors vital signs | Likely | 73 Participants |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | Likely to use a device that monitors vital signs | Unlikely | 22 Participants |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | For a device that sense overdose - likely to wear glasses | Likely | 24 Participants |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | For a device that sense overdose - likely to wear glasses | Unlikely | 70 Participants |
| Patient 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 |
| Patient 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 |
| Patient 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 |
| Patient Participants | Functional and Aesthetic Preferences for Device-based Opioid Overdose Intervention | For a device that sense overdose - likely to wear an ankle strap | Unlikely | 52 Participants |