Clinical trial NCT05325788: Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use
Official title: Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Opioid Use Disorder
Keywords: intervention development
technology
mHealth
substance use disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the e-Covery app measured by average time spent using the app assessed at day 28
timeFrame: Day 28
measure: Feasibility of the e-Covery app assessed through qualitative interviews
timeFrame: Day 28
measure: Average acceptability rating of the e-Covery app measured by 5-point Likert scale
timeFrame: up to Day 28
measure: Acceptability of the e-Covery app assessed through qualitative interviews
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: ENRICH Lab
state: Connecticut
Study officials:
affiliation: Yale University School of Public Health
name: Adam Viera
role: PRINCIPAL_INVESTIGATOR
References: