BE Intervention for Naloxone Uptake

Harm Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064981
• Other study ID #: 831618
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 29, 2019

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 29, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Living in the Philadelphia area

• Attended the study naloxone training.

Exclusion Criteria:

• Unable to consent

Related Conditions & MeSH terms

• Harm Reduction

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Naloxone carrying	Assessed by photo documentation via text message.	Proportion of successful naloxone check-ins at 14 random time points over a 4 week period post-intervention.