Clinical trial NCT04097340: Attention Training on Smartphones
Official title: Attention Training on Smartphones (The ATS Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attention
Substance Use
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to evaluate a new method that may influence attention, cravings and substance use called attention training, which will be delivered on a smartphone through an application (app). The study team would like to know what participants think of this new method and to determine if research involving this app is feasible. Eligible participants will use the app for a period of two weeks and attend a total of 4 appointments at our study location.

Detailed description: The goal of this study is to evaluate a new method that may influence attention, cravings and substance use called attention training, which will be delivered on a smartphone through an application (app). The study team would like to know what participants think of this new method and to determine if research involving this app is feasible. Eligible participants will use the app for a period of two weeks and attend a total of 4 appointments at our study location. A primary aim of the study is to assess feasibility, usability and acceptability of mobile Attention Bias Retraining (ABR) by quantifying adherence (in lab and natural environment), self-reported ease of use, perceived value and likelihood of future use. Another primary aim of the study is to determine if ABR reduces attentional bias (AB) for opioids in those with Opioid Use Disorders (OUD) compared to a control training condition. A secondary aim of the study is to assess whether ABR reduces opioid craving to a greater extent than a control training condition based on self-report. Another secondary aim is to assess whether ABR is associated with less opioid use during the training period than a control training condition based on self-report and urinalysis. An exploratory aim of the study is to measure levels of self-reported pain pre- and post- ABR. Another exploratory aim is to examine the durability of ABR effect on AB/craving/ opioid use at 1-month follow-up.

Interested individuals will first complete a in-person screening appointment including a medical and psychiatric screening and questionnaires covering topics including substance and alcohol use, cigarette smoking, and sexual behaviors. Eligible participants who enroll in the study will next complete an orientation appointment when study staff will teach participants how to use the study app and answer any questions that arise. Participants will then be randomly assigned (like a flip of a coin) to one of two conditions. Each condition involves use of a smartphone app. One smartphone app includes a task that targets attention directed to substance-related cues while the other app includes a similar task that does not target attention in this way. Neither the participants nor the staff members will know which condition the participant has been randomly assigned to. Participants will be informed of the assigned condition by study staff after the completion of the study. In most prior studies, attention training has been delivered on a desktop computer in a laboratory setting. Initial research has shown that attention training can be used in real-world settings using hand-held devices such as smartphones.

Eligibility criteria: Inclusion Criteria:

* Able to read and write in English fluently and complete study evaluations
* 6-week availability to participate in the study
* Willing and able to answer questions on smartphones up to 4 times daily for about 10 minutes each time.
* On Suboxone (or methadone if recruitment does not progress as planned) for at least one month (verified by urine drug test- unless using transdermal patch because 1/3 of patients using the patch will not show positive urine screen; and verified by opioid replacement therapy-provider)"
* Meet DSM-5 criteria for opioid use disorder

Exclusion Criteria:

* Use (outside of prescription) for drugs that negatively interact with one another
* Meet severe DSM-5 criteria for current substance use disorders other than opioids, nicotine or cannabis (e.g., current stimulant use disorder) and have used that substance within the past 30 days based on self-report or a positive urine drug test
* Severe psychiatric conditions
* Color blindness and/or uncorrected defective vision

Primary outcomes:
measure: Modified System Usability Scale scores overall and comparisons between study conditions
timeFrame: Post-two-week intervention period
measure: Completion of daily assessments and attendance at study appointments.
timeFrame: Two-week intervention period
measure: Change in attentional bias (AB)
timeFrame: Two-week intervention period
Secondary outcomes:
measure: Change in craving levels
timeFrame: Two-week intervention period
measure: Change in opioid use
timeFrame: Two-week intervention period
measure: Change in pain levels
timeFrame: Two-week intervention period
measure: Durability of retraining effect on attentional bias
timeFrame: 1-month-follow-up
measure: Durability of retraining effect on craving
timeFrame: 1-month-follow-up
measure: Durability of retraining effect on opioid use
timeFrame: 1-month-follow-up
measure: Durability of retraining effect on pain levels
timeFrame: 1-month-follow-up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: EDGE Laboratory
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Leeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: