Attention Training on Smartphones

NCT04097340 | Terminated DMC

• 2 other identifiers: IRB201800947OCR19813
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention; Substance Use

Outcome Measures

Primary Outcomes (3)

• Modified System Usability Scale scores overall and comparisons between study conditions

  Seven-point Likert scale items regarding the usability and acceptability of the app (higher score indicates greater usability and acceptability). Higher scores indicate greater usability and acceptability. The attentional bias retraining and control training conditions will also be compared on usability and acceptability scores.

  Post-two-week intervention period

• Completion of daily assessments and attendance at study appointments.

  Completion of a high percentage of smartphone assessments and attendance at appointments will show feasibility. Completion of 75% of assessments and attendance at 75% of study appointments will indicate feasibility.

  Two-week intervention period

• Change in attentional bias (AB)

  Determine if attentional bias retraining reduces attentional bias for opioids compared to a control training condition. Reaction times from both the Visual probe (VP) task and the drug Stroop task will be examined to assess change in AB across time points.

  Two-week intervention period

Secondary Outcomes (7)

• Change in craving levels

  Two-week intervention period

• Change in opioid use

  Two-week intervention period

• Change in pain levels

  Two-week intervention period

• Durability of retraining effect on attentional bias

  1-month-follow-up

• Durability of retraining effect on craving

  1-month-follow-up

Study Arms (2)

Attentional Training Group

ACTIVE COMPARATOR

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 participant nor the staff members working on the study will know which condition the participant has been randomly assigned to.

Device: Attentional Bias Retraining (ABR)

Control Training Group

PLACEBO COMPARATOR

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 participant nor the staff members working on the study will know which condition the participant has been randomly assigned to.

Device: Control Training

Interventions

Attentional Bias Retraining (ABR) DEVICE

Participants randomized to this intervention will receive 2 weeks of ABR for opioids delivered via a mobile device.

Attentional Training Group

Control Training DEVICE

Participants randomized to this intervention will receive 2 weeks of training without ABR, delivered via a mobile device.

Control Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and write in English fluently and complete study evaluations
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

EDGE Laboratory

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Robert Leeman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 20, 2019
• Study Start: September 1, 2019
• Primary Completion: August 4, 2021
• Study Completion: June 17, 2023
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)