Harm ReductionNCT06064981
BE Intervention for Naloxone Uptake
A study testing Text message nudges and Commitment contract in people with Harm Reduction, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The overall objective of this study is to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend an opioid overdose reversal training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Harm Reduction
- What is being tested?
- Text message nudges and Commitment contract
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2019to 29 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living in the Philadelphia area
- Attended the study naloxone training.
Who cannot join
- Unable to consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Behavioral Economic Approaches to Increase Naloxone Aquisition and Carrying in an Urban Environment
The overall objective of this study is to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend an opioid overdose reversal training.
Read the detailed description
This study aims to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend opioid overdose reversal training. The study consists of two distinct randomized controlled trials (Aim 2 and Aim 3) and has three primary objectives:
Aim 1: To diagnose behavioral bottlenecks to naloxone acquisition and carrying. This aim involves analyzing data from naloxone training sessions to identify barriers to acquiring and carrying naloxone. These barriers will be mapped to cognitive biases, such as optimism bias and overconfidence, and will inform the behavioral interventions in Aims 2 and 3.
Aim 2: To test the impact of a behavioral economics intervention on naloxone acquisition. This aim involves a randomized controlled trial with 60 participants. The intervention group will receive commitment pledges, acquisition plans, and tailored text message nudges to increase naloxone acquisition within one week of training. The control group will receive standard training. The primary endpoint is the time it takes for participants to acquire naloxone post-training.
Aim 3: To test the impact of a text nudge intervention on naloxone carrying. This aim also involves a randomized controlled trial, where all participants receive naloxone at the training. The intervention group will receive tailored text message nudges to encourage consistent naloxone carrying. The control group (n=30) will not receive these nudges. The primary endpoint is the consistency of naloxone carrying post-training.
- Conditions
- Harm Reduction
- Being tested
- Text message nudges, Commitment contract
- Medical subject headings
- Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message nudgesBehavioural
Fourteen text message "nudges," tailored to address specific barriers and concerns regarding naloxone acquisition and carrying. These barriers were identified using qualitative interviews conducted by the authors in prior studies. Examples included: optimism bias (e.g., beliefs that participants were unlikely to encounter someone who had overdosed in their daily lives), and identity bias (e.g., beliefs that participants were not the type of people who could save a life).
Commitment contractBehavioural
In addition to the training, participants in the third arm were asked to sign commitment contracts, which had language in which they "committed" to carrying/acquiring naloxone.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control arm receive usual care. In this case they receive naloxone training only. The training involves a 1-hour in-person overdose recognition and reversal course, which addressed the following topics: the scope and nature of the opioid overdose epidemic nationally and locally in Philadelphia, signs of opioid overdose, strategies for approaching or interacting with a person who is suspected to have overdosed, administration of naloxone in its nasal spray formulation, what to expect after administering naloxone, legal considerations and Good Samaritan protection, and how and where to acquire naloxone. |
| Text message nudges | Experimental | Participants in this arm receive text message nudges with salient messaging around overdose and naloxone. They also receive naloxone training. Receives: Behavioral: Text message nudges |
| Commitment contract | Experimental | Participants in this arm receive sign a commitment contract agreeing to obtain or carry naloxone. They also receive naloxone training. Receives: Behavioral: Commitment contract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Naloxone carrying
Assessed by photo documentation via text message.
Measured: Proportion of successful naloxone check-ins at 14 random time points over a 4 week period post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Feb 2019
- Primary completion30 Aug 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Harm ReductionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Cannuscio, University of Pennsylvania
- Investigators
- Carolyn Cannuscio, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064981
- Sponsor's protocol ID
- 831618
- Status last verified
- Jan 2024
- First submitted
- 26 Sep 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Approaches to Increase Naloxone Aquisition and Carrying in an Urban Environment
- ClinicalTrials.gov ID
- NCT06064981
- Acronym / sponsor ID
- 831618
- Conditions
- Harm Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend an opioid overdose reversal training.
Detailed description
This study aims to use behavioral economics interventions to increase naloxone acquisition and carrying among participants who attend opioid overdose reversal training. The study consists of two distinct randomized controlled trials (Aim 2 and Aim 3) and has three primary objectives:
Aim 1: To diagnose behavioral bottlenecks to naloxone acquisition and carrying. This aim involves analyzing data from naloxone training sessions to identify barriers to acquiring and carrying naloxone. These barriers will be mapped to cognitive biases, such as optimism bias and overconfidence, and will inform the behavioral interventions in Aims 2 and 3.
Aim 2: To test the impact of a behavioral economics intervention on naloxone acquisition. This aim involves a randomized controlled trial with 60 participants. The intervention group will receive commitment pledges, acquisition plans, and tailored text message nudges to increase naloxone acquisition within one week of training. The control group will receive standard training. The primary endpoint is the time it takes for participants to acquire naloxone post-training.
Aim 3: To test the impact of a text nudge intervention on naloxone carrying. This aim also involves a randomized controlled trial, where all participants receive naloxone at the training. The intervention group will receive tailored text message nudges to encourage consistent naloxone carrying. The control group (n=30) will not receive these nudges. The primary endpoint is the consistency of naloxone carrying post-training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control arm receive usual care. In this case they receive naloxone training only. The training involves a 1-hour in-person overdose recognition and reversal course, which addressed the following topics: the scope and nature of the opioid overdose epidemic nationally and locally in Philadelphia, signs of opioid overdose, strategies for approaching or interacting with a person who is suspected to have overdosed, administration of naloxone in its nasal spray formulation, what to expect after administering naloxone, legal considerations and Good Samaritan protection, and how and where to acquire naloxone. |
| Text message nudges | Experimental | Behavioral: Text message nudgesParticipants in this arm receive text message nudges with salient messaging around overdose and naloxone. They also receive naloxone training. |
| Commitment contract | Experimental | Behavioral: Commitment contractParticipants in this arm receive sign a commitment contract agreeing to obtain or carry naloxone. They also receive naloxone training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Living in the Philadelphia area
- Attended the study naloxone training.
Key exclusion criteria (1 listed)
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message nudgesFourteen text message "nudges," tailored to address specific barriers and concerns regarding naloxone acquisition and carrying. These barriers were identified using qualitative interviews conducted by the authors in prior studies. Examples included: optimism bias (e.g., beliefs that participants were unlikely to encounter someone who had overdosed in their daily lives), and identity bias (e.g., beliefs that participants were not the type of people who could save a life). | Behavioural | Text message nudges |
| Commitment contractIn addition to the training, participants in the third arm were asked to sign commitment contracts, which had language in which they "committed" to carrying/acquiring naloxone. | Behavioural | Commitment contract |
Primary outcome
Naloxone carrying
Time frame: Proportion of successful naloxone check-ins at 14 random time points over a 4 week period post-intervention.
Assessed by photo documentation via text message.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Cannuscio principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message nudges and Commitment contract in people with Harm Reduction, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Naloxone carrying (time frame: Proportion of successful naloxone check-ins at 14 random time points over a 4 week period post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.