BE Intervention for Naloxone Uptake

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT06064981

Collaborator

(none)

137

Enrollment

Location

Arms

10.9

Actual Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Harm Reduction	Behavioral: Text message nudges Behavioral: Commitment contract	N/A

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

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Behavioral Economic Approaches to Increase Naloxone Aquisition and Carrying in an Urban Environment

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Aug 30, 2019

Actual Study Completion Date :

Dec 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Participants in the control arm receive usual care. In this case they received naloxone training only. The training involved 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.
Experimental: Text message nudges	Behavioral: Text message nudges 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).
Experimental: Commitment contract	Behavioral: Commitment contract 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.

Arm

Intervention/Treatment

No Intervention: Control

Participants in the control arm receive usual care. In this case they received naloxone training only. The training involved 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.

Experimental: Text message nudges

Behavioral: Text message nudges

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).

Experimental: Commitment contract

Behavioral: Commitment contract

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.

Outcome Measures

Primary Outcome Measures

Naloxone carrying [14 random check-ins over a 4 week period post-intervention.]
Assessed by photo documentation via text message.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Living in the Philadelphia area
Attended the study naloxone training.

Exclusion Criteria:

Unable to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carolyn Cannuscio, Associate Professor, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT06064981

Other Study ID Numbers:

831618

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 3, 2023