Older Adults, Methadone, and Cognitive Function

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder; Cognitive Ability General

• Registration Number: NCT07153029
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

The increasing prevalence of opioid use disorder (OUD) among older adults, coupled with high overdose rates and cognitive impairments associated with opioid use, highlights a critical gap in addiction treatment. Cognitive impairments can persist despite treatment and negatively impact recovery outcomes, yet cognitive screening and interventions are rarely integrated into OUD care. This study aims to evaluate the feasibility of remotely delivered, smartphone-based cognitive assessments (administered through NeuroUX HIPAA-compliant web-based software) for older adults (55+) in methadone treatment. The tasks have been "gamified" to make them engaging and brief, which could be appealing to patients. They will complete the tasks for 15 days using the phone provided or their own phone. During days 6-15 of testing, tasks will become incrementally more difficult based on participant performance to assess the feasibility of cognitive training. Cognitive training uses engaging games or tasks to strengthen thinking skills like memory and focus, much like physical exercise strengthens your body. Adherence, acceptability, and usability of the tasks will be assessed. Secondary analyses will explore relationships between task performance and participant characteristics (e.g., baseline cognitive functioning, methadone dose, timing of methadone dose). Findings from this pilot study will provide foundational data for a future NIH grant application to develop and test digital cognitive assessment and training interventions tailored to older adults in addiction treatment. By addressing a critical yet understudied aspect of OUD care this research has the potential to enhance treatment engagement, improve clinical outcomes, and support long-term recovery in the growing older population.

Detailed Description

The purpose of this study is to assess cognitive functioning through a smartphone-based application (NeuroUX) across 15 days among patients in methadone treatment for opioid use disorder who are age 55 or older. Aims include:

Aim 1 (Cognitive Testing): For the first 5 days of testing, we will examine adherence, acceptability, and useability of twice daily remote cognitive assessment of executive functioning and learning/memory (N-back, Stroop/Color Trick Task, and Verbal Learning Memory Task) and brief ecological momentary testing (questions that assess recent substance use and craving) among older patients (N=20) in OUD treatment. Hypothesis: Patients will demonstrate high adherence (\> 70% completed assessments9), acceptability (\> 70% high satisfaction), and usability (mean score \> 68 on the System Usability Scale10).

Aim 2 (Cognitive Training): For the days 6-15 of testing, tasks will be made slightly more difficult based on the participants performance (higher performance = more difficulty). We will examine adherence and acceptability (see Aim 1) during this phase of the task and accuracy on tasks to see if they correspond to number of times completing the task and baseline cognitive assessments. Hypothesis: Patients will demonstrate high adherence and acceptability, and their performance on tasks will increase over time.

Exploratory Aim: examine the relationship between performance on the cognitive tasks and baseline cognitive functioning and follow-up function.

This study is a prospective feasibility trial evaluating the use of brief, daily, remotely delivered cognitive assessments over 15 consecutive days among patients aged 55 years and older receiving methadone treatment for opioid use disorder (OUD). Cognitive assessments will be administered via a study-provided smartphone (or patient's personal phone, depending on preference) using validated tasks targeting executive function (N-back for working memory, Stroop task/Color Trick Task for inhibitory control) and learning/memory (Variable Difficulty List Memory Test). This remote, app-based approach offers a more engaging and less burdensome alternative to traditional, time-intensive in-person cognitive testing commonly used in substance use research. Tasks are designed to be brief (3-4 minutes), visual, engaging, and more aligned with "brain games" than traditional cognitive tasks.

Before starting the daily assessments, participants will attend a baseline session to complete measures of demographics, substance use history and treatment, health characteristics, mood, quality of life, and baseline cognitive performance. During this session, participants will also receive the study smartphone (if they aren't using their own), be oriented to how the tasks will look on their phone, and receive training on completing tasks.

After the 15-day smartphone assessment period, participants will complete a follow-up session that includes repeat measures of mood, quality of life, and cognitive performance, as well as questions about their experience with and perceptions of the smartphone-based cognitive games.

All participants (target number of completers = 20) will complete the same study procedures; no randomization will be used and all study procedures will be transparent to study participants.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-10-20
• Primary Completion: 2026-10-31
• Study Completion: 2027-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1) age 55 and older, 2) currently in outpatient methadone treatment for opioid use disorder, 3) participant is alert/able to communicate/able to give acceptable answers on the "Evaluation to Sign Consent form, 4) participant has normal or correct to normal vision

Exclusion Criteria

• 1) age 54 or younger, 2) not in methadone treatment for opioid use disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence to smartphone task completion	across 15 days of use	proportion of completed assessments on the smartphone
Satisfaction with smartphone tasks	across 15 days of use	Proportion reporting high satisfaction (\>70%) with smartphone tasks
Usability of smartphone tasks	after 15 days of use	mean score \> 68 on the System Usability Scale
Cognitive Task Performance	15 days of smartphone tasks	Performance on each of 3 cognitive tasks will be assessed for each time a task is completed. Performance will be compared across days of use.

Secondary Outcome Measures

Name	Time	Method
Laboratory cognitive functioning	1 month (pre-post 15 day cognitive tasks on smartphone)	Cognitive functioning in the laboratory before and after smartphone task completion will be assessed using the Iowa Trails Making Task). Changes in performance will be examined pre- and post and analyzed with respect to performance on the smartphone-based cognitive tasks.