Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use

NCT ID: NCT05325788

Last Updated: 2024-02-16

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-04

Study Completion Date

2023-11-07

Brief Summary

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This project aims to improve the health of individuals engaged in co-occurring alcohol and opioid use by supporting the maintenance of behavior change initiated in substance use treatment. Building on prior research, this study will entail a stage 1b pilot to test the feasibility and acceptability of an app-based intervention for individuals reporting co-occurring alcohol and opioid use. The intervention will involve modifying an app currently used in a research study to collect GPS information to send push notifications when individuals encounter self-identified place-based triggers. Thirty individuals completing substance use treatment will consent to use the app for a thirty-day pilot period and will complete assessments of intervention feasibility and acceptability. Using within-subject tests, the analysis will summarize participant responses to assessments and will compare the use of general messaging to place-specific messaging.

Detailed Description

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Co-occurring alcohol and opioid use is a public health issue in need of attention and has been linked to various health concerns, such as motor vehicle accidents and drug poisoning and overdose. Individuals engaged in polysubstance use face myriad challenges in sustaining recovery after completion of substance use treatment and return to use after treatment completion is common. One challenge faced by individuals in early recovery is how specific places can serve as triggers for cravings that can precipitate return to use. Smartphone apps have the potential to curtail the effects of such triggers by providing messaging (or "nudging") when individuals are in locations identified as triggers of return to use. To date, research on app-based interventions has yet to examine the effect of such "nudging" independently and has not looked at its effectiveness in addressing co-occurring alcohol and opioid use.

This project aims to improve the health of individuals engaged in co-occurring alcohol and opioid use by supporting the maintenance of behavior change initiated in substance use treatment. Building on prior research, this study will entail a stage 1b pilot to test the feasibility and acceptability of an app-based intervention for individuals reporting co-occurring alcohol and opioid use. The intervention will involve modifying an app currently used in a research study to collect GPS information to send push notifications when individuals encounter self-identified place-based triggers. Thirty individuals completing substance use treatment will consent to use the app for a thirty-day pilot period and will complete assessments of intervention feasibility and acceptability. Using within-subject tests, the analysis will summarize participant responses to assessments and will compare the use of general messaging to place-specific messaging.

Conditions

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Alcohol Use Disorder Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single daily message followed by location-based messaging

Participants in this condition receive a single daily message through the intervention app for two weeks (14 days) followed by location-based messaging for two weeks (14 days).

Group Type OTHER

e-Covery

Intervention Type OTHER

Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.

Comparator Condition

Intervention Type OTHER

Through the e-Covery app, participants will receive a single general message sent daily in the morning.

Location-based messaging followed by single daily message

Participants in this condition receive location-based messaging through the intervention app for two weeks (14 days) followed by a single daily message for two weeks (14 days) .

Group Type OTHER

e-Covery

Intervention Type OTHER

Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.

Comparator Condition

Intervention Type OTHER

Through the e-Covery app, participants will receive a single general message sent daily in the morning.

Interventions

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e-Covery

Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.

Intervention Type OTHER

Comparator Condition

Through the e-Covery app, participants will receive a single general message sent daily in the morning.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* speak English
* report enrollment in a substance use treatment program at baseline
* report use above the screening tool thresholds for problem alcohol use
* own a smartphone
* reside in Connecticut at baseline with no plans to move in the following month

Exclusion Criteria

* Inability to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Viera

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Public Health

Locations

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ENRICH Lab

New Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1F31AA028992-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000031915

Identifier Type: -

Identifier Source: org_study_id

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