Older Adults, Methadone, and Cognitive Function

NCT07153029 | Enrolling By Invitation DMC

• 1 other identifier: HP-00116032
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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 the 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 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.

Conditions

Opioid Use Disorder; Cognitive Ability General

Keywords

older adults; cognition; feasibility; ecological momentary assessment

Outcome Measures

Primary Outcomes (4)

• Adherence to smartphone task completion

  proportion of completed assessments on the smartphone

  across 15 days of use

• Satisfaction with smartphone tasks

  Proportion reporting high satisfaction (\>70%) with smartphone tasks

  across 15 days of use

• Usability of smartphone tasks

  mean score \> 68 on the "System Usability Scale" a reliable, low-cost usability scale that can be used for global assessments of systems usability. Higher scores indicate greater usability.

  after 15 days of use

• Cognitive Task Performance

  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.

  15 days of smartphone tasks

Secondary Outcomes (1)

• Laboratory cognitive functioning

  1 month (pre-post 15 day cognitive tasks on smartphone)

Other Outcomes (1)

• Montreal Cognitive Asesssment (MOCA) (baseline cognitive performance)

  Baseline assessment (before 15 days of smartphone task completion)

Study Arms (1)

Smartphone-based assessments and cognitive tasks

EXPERIMENTAL

All participants will complete a baseline session to colelct data related to demographics, health history/status, and cognitive functioning. Participants will be oriented to the smartphone application which is delivered via NeuroUX cloud-based technology which send a text message to the smartphone as a prompt for tasks which will be administered across 15 days. All participants complete the same tasks and duration of tasks. Then all participants complete a follow-up assessment to examine their preferences related to the smartphone and cognitive function.

Behavioral: Smartphone based cognitive tasks

Interventions

Smartphone based cognitive tasks BEHAVIORAL

15 days Smartphone/Cellphone tasks: Using NeuroUX smartphone testing software, Cognitive "games"/tasks lasting approximately 3-4 minutes each will be administered through the a smartphone application and will be prompted via text message twice per day across 15 consecutive days in the morning (8-11am) and evening (5-8). Tasks were chosen to measure aspects of diverse aspects of cognitive that are impaired among patients taking methadone, including N-back task (working memory), the Stroop Task (executive function/cognitive control), and the Variable Difficulty List Memory Test (learning and memory). The 15 days will include two types of task administration: a) Testing Phase: tasks administered at a consistent, fixed difficulty level (days 1-5) b) Remediation Phase: increasing task difficulty in response to participant performance (days 6-15). To encourage adherence, researchers will contact participants to remind them of task completion.

Smartphone-based assessments and cognitive tasks

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• age 54 or younger
• not in methadone treatment for opioid use disorder

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UM Addiction Treatment Programs at 1001 West Pratt

Baltimore, Maryland, 21124, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Psychiatry, University of Maryland School of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Start date: date when study is completed and data analyses are completed End date: 5 years from date of study completion and data analyses completed
• Access Criteria: Request sent to Principal Investiagator and approved by Principal Investigator

Locations

US (1)