Older Adults, Methadone, and Cognitive Function

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07153029
Status
Recruiting
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Conditions

  • Cognitive Ability General
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 3, 2024
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Smartphone-based assessments and cognitive tasks
    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.

Primary Outcome Measure

Adherence to smartphone task completion [ Time Frame: across 15 days of use ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UM Addiction Treatment Programs at 1001 West PrattBaltimoreMaryland21124
Eric Weintraub, MD
[email protected]
443-462-3400
Heather Fitzsimmons
[email protected]
443-462-3400
Bethea Kleykamp, PhD (PRINCIPAL_INVESTIGATOR)

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