BE Intervention for Naloxone Uptake

NCT ID: NCT06064981

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-12-29

Brief Summary

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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

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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

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Harm Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Text message nudges

Participants in this arm receive text message nudges with salient messaging around overdose and naloxone. They also receive naloxone training.

Group Type EXPERIMENTAL

Text message nudges

Intervention Type BEHAVIORAL

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

Participants in this arm receive sign a commitment contract agreeing to obtain or carry naloxone. They also receive naloxone training.

Group Type EXPERIMENTAL

Commitment contract

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Living in the Philadelphia area
* Attended the study naloxone training.

Exclusion Criteria

* Unable to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Cannuscio

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolyn Cannuscio

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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831618

Identifier Type: -

Identifier Source: org_study_id

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