Alcohol Use DisorderNCT05325788
Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use
A study testing e-Covery and Comparator Condition in people with Alcohol Use Disorder and Opioid Use Disorder, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Opioid Use Disorder
- What is being tested?
- e-Covery and Comparator Condition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder, Opioid Use Disorder
- Being tested
- e-Covery, Comparator Condition
- Keywords
- intervention development, technology, mHealth, substance use disorder
- Medical subject headings
- Alcoholism, Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-CoveryOther
Through the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers.
Comparator ConditionOther
Through the e-Covery app, participants will receive a single general message sent daily in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Single daily message followed by location-based messaging | Other | 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). Receives: Other: e-Covery; Other: Comparator Condition |
| Location-based messaging followed by single daily message | Other | 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) . Receives: Other: e-Covery; Other: Comparator Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the e-Covery app measured by average time spent using the app assessed at day 28
Feasibility is assessed by average time spent using the app, measured through app usage metrics. More time spent using the app indicates more engagement.
Measured: Day 28
Feasibility of the e-Covery app assessed through qualitative interviews
Feasibility is assessed based on participant responses to questions during an interview taking place after the 28-day pilot period. Participants will be asked about the ease of using the e-Covery app and responses will be coded and analyzed to identify themes related to feasibility. Qualitative findings will be compared to the quantitative findings above using an integrated analysis characteristics of mixed methods approaches.
Measured: Day 28
Average acceptability rating of the e-Covery app measured by 5-point Likert scale
Average acceptability is assessed at Days 14 and 28 based on participants' opinion of and satisfaction with the intervention, measured through completion of daily surveys assessing elements of acceptability using Likert scale response options. Higher ratings correspond to higher intervention acceptability. Intent of the outcome measure is to assess the average score from Day 1 through Day 14 compared to the average score from Day 15 through Day 28 to compare the average ratings between conditions.
Measured: up to Day 28
Acceptability of the e-Covery app assessed through qualitative interviews
Acceptability is assessed based on participant responses to questions during an interview taking place after the 28-day pilot period. Participants will be asked about their satisfaction with the e-Covery app and intervention and responses will be coded and analyzed to identify themes related to acceptability. Qualitative findings will be compared to the quantitative findings above using an integrated analysis characteristics of mixed methods approaches.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start4 Nov 2022
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Adam Viera, Principal investigator, Yale University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325788
- Sponsor's protocol ID
- 2000031915
- Other IDs
- 1F31AA028992-01
- Status last verified
- Feb 2024
- First submitted
- 24 Mar 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing e-Covery, an App-based Intervention to Support Individuals With Co-occurring Problem Alcohol and Opioid Use
- ClinicalTrials.gov ID
- NCT05325788
- Acronym / sponsor ID
- 2000031915
- Conditions
- Alcohol Use Disorder, Opioid Use Disorder
- Keywords
- intervention development, technology, mHealth, substance use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single daily message followed by location-based messaging | Other | Other: e-Covery, Other: Comparator ConditionParticipants 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). |
| Location-based messaging followed by single daily message | Other | Other: e-Covery, Other: Comparator ConditionParticipants 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) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-CoveryThrough the e-Covery app, participants will receive place-specific messages, sent when participants pass locations identified as triggers. | Other | Location-based messaging followed by single daily message, Single daily message followed by location-based messaging |
| Comparator ConditionThrough the e-Covery app, participants will receive a single general message sent daily in the morning. | Other | Location-based messaging followed by single daily message, Single daily message followed by location-based messaging |
Primary outcome
Feasibility of the e-Covery app measured by average time spent using the app assessed at day 28
Time frame: Day 28
Feasibility is assessed by average time spent using the app, measured through app usage metrics. More time spent using the app indicates more engagement.
Feasibility of the e-Covery app assessed through qualitative interviews
Time frame: Day 28
Feasibility is assessed based on participant responses to questions during an interview taking place after the 28-day pilot period. Participants will be asked about the ease of using the e-Covery app and responses will be coded and analyzed to identify themes related to feasibility. Qualitative findings will be compared to the quantitative findings above using an integrated analysis characteristics of mixed methods approaches.
Average acceptability rating of the e-Covery app measured by 5-point Likert scale
Time frame: up to Day 28
Average acceptability is assessed at Days 14 and 28 based on participants' opinion of and satisfaction with the intervention, measured through completion of daily surveys assessing elements of acceptability using Likert scale response options. Higher ratings correspond to higher intervention acceptability. Intent of the outcome measure is to assess the average score from Day 1 through Day 14 compared to the average score from Day 15 through Day 28 to compare the average ratings between conditions.
Acceptability of the e-Covery app assessed through qualitative interviews
Time frame: Day 28
Acceptability is assessed based on participant responses to questions during an interview taking place after the 28-day pilot period. Participants will be asked about their satisfaction with the e-Covery app and intervention and responses will be coded and analyzed to identify themes related to acceptability. Qualitative findings will be compared to the quantitative findings above using an integrated analysis characteristics of mixed methods approaches.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Viera principal investigator
Yale University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-Covery and Comparator Condition in people with Alcohol Use Disorder and Opioid Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the e-Covery app measured by average time spent using the app assessed at day 28 (time frame: Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.