An observational study in Opioid Overdose, Opioid-use Disorder and Substance Use Disorders, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-07-07.
Sponsored by University of Pennsylvania · Observational
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 97 is below the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study population is non-pregnant individuals over the age of 21 with opioid use disorder.
Have used opioids for more than 3 months or will be having surgery where opioids will be administered
Exclusion Criteria:
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.
Other: Survey · Other: Interview
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.
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.
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
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
| Milestone | Patient Participants |
|---|---|
| Started | 97 |
| Completed | 97 |
| Not completed | 0 |
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.
| Participants | Patient Participants |
|---|---|
| Likely | 69 |
| Unlikely | 22 |
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.
| Participants | Patient Participants |
|---|---|
| Likely to use a device that senses an overdose — Likely | 70 |
| Likely to use a device that senses an overdose — Unlikely | 26 |
| Likely to use a device that indicates the wearer is at risk of an overdose — Likely | 66 |
| Likely to use a device that indicates the wearer is at risk of an overdose — Unlikely | 29 |
| Likely to use a device that straps naloxone to the body for a bystander to administer — Likely | 52 |
| Likely to use a device that straps naloxone to the body for a bystander to administer — Unlikely | 44 |
| Likely to use a device that senses an overdose and administers naloxone if needed — Likely | 64 |
| Likely to use a device that senses an overdose and administers naloxone if needed — Unlikely | 32 |
| Likely to use a device that alerts medical first responders if needed — Likely | 68 |
| Likely to use a device that alerts medical first responders if needed — Unlikely | 28 |
| Likely to use a device that alerts bystanders if needed — Likely | 60 |
| Likely to use a device that alerts bystanders if needed — Unlikely | 35 |
| Likely to use a device that monitors vital signs — Likely | 73 |
| Likely to use a device that monitors vital signs — Unlikely | 22 |
| For a device that sense overdose - likely to wear a necklace — Likely | 48 |
| For a device that sense overdose - likely to wear a necklace — Unlikely | 46 |
| For a device that sense overdose - likely to wear a canula — Likely | 12 |
| For a device that sense overdose - likely to wear a canula — Unlikely | 84 |
| For a device that sense overdose - likely to wear a skin-patch on chest — Likely | 42 |
| For a device that sense overdose - likely to wear a skin-patch on chest — Unlikely | 54 |
| For a device that sense overdose - likely to wear a skin-patch on upper arm — Likely | 53 |
| For a device that sense overdose - likely to wear a skin-patch on upper arm — Unlikely | 43 |
| For a device that sense overdose - likely to wear a watch-appearing bracelet — Likely | 72 |
| For a device that sense overdose - likely to wear a watch-appearing bracelet — Unlikely | 22 |
| For a device that sense overdose - likely to wear a wrist bracelet — Likely | 69 |
| For a device that sense overdose - likely to wear a wrist bracelet — Unlikely | 26 |
| For a device that sense overdose - likely to wear a shoulder strap — Likely | 21 |
| For a device that sense overdose - likely to wear a shoulder strap — Unlikely | 30 |
| For a device that sense overdose - likely to wear a thigh strap — Likely | 15 |
| For a device that sense overdose - likely to wear a thigh strap — Unlikely | 33 |
| For a device that sense overdose - likely to wear a chest strap — Likely | 22 |
| For a device that sense overdose - likely to wear a chest strap — Unlikely | 72 |
| For a device that sense overdose - likely to wear glasses — Likely | 24 |
| For a device that sense overdose - likely to wear glasses — Unlikely | 70 |
| For a device that sense overdose - likely to wear a knee brace — Likely | 16 |
| For a device that sense overdose - likely to wear a knee brace — Unlikely | 32 |
| For a device that sense overdose - likely to wear an ankle strap — Likely | 44 |
| For a device that sense overdose - likely to wear an ankle strap — Unlikely | 52 |
Collected over Adverse event data was collected at the time of survey administration (1 hour).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Participants | — | — | 0/97 (0%) |
| Age, Continuous(Years) | Patient Participants |
|---|---|
| Mean | 41 (37 to 49) |
| Sex: Female, Male(Participants) | Patient Participants |
|---|---|
| Female | 40 |
| Male | 57 |
| Ethnicity (NIH/OMB)(Participants) | Patient Participants |
|---|---|
| Hispanic or Latino | 23 |
| Not Hispanic or Latino | 74 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Patient Participants |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 30 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 20 |
| Housing Status(Participants) | Patient Participants |
|---|---|
| Homeless | 31 |
| House | 7 |
| Apartment | 8 |
| Shelter | 36 |
| Unknown | 15 |
| Started After Injury/Surgery(Participants) | Patient Participants |
|---|---|
| Yes | 46 |
| No | 51 |
| Duration of Opioid Use(years) | Patient Participants |
|---|---|
| Mean | 12 (8 to 20) |
| Opioid Use Frequency (Days per Week)(Participants) | Patient Participants |
|---|---|
| 1 | 0 |
| 2-3 | 9 |
| 4-6 | 7 |
| 7 | 80 |
| Unknown | 1 |
9 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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