NCT06064981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

September 26, 2023

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

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.

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.

Behavioral: Commitment contract

Interventions

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).

Text message nudges

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.

Commitment contract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Harm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Carolyn Cannuscio

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

February 1, 2019

Primary Completion

August 30, 2019

Study Completion

December 29, 2019

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations