Older Adults, Methadone, and Cognitive Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
age 54 or younger
not in methadone treatment for opioid use disorder
Trial design
Design model
Single group
Treatments tested in this trial
Smartphone based cognitive tasks
Behavioral15 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Smartphone-based assessments and cognitive tasksExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adherence to smartphone task completion
proportion of completed assessments on the smartphone
Time frame
across 15 days of use2
Satisfaction with smartphone tasks
Proportion reporting high satisfaction (\>70%) with smartphone tasks
Time frame
across 15 days of use3
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.
Time frame
after 15 days of use4
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.
Time frame
15 days of smartphone tasksSecondary outcomes
1
Laboratory cognitive functioning
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.
Time frame
1 month (pre-post 15 day cognitive tasks on smartphone)Other outcomes
1
Montreal Cognitive Asesssment (MOCA) (baseline cognitive performance)
The Montreal Cognitive Assessment is a standardized measure of cognitive functioning which will be collected at baseline. We will examine its relationship with smartphone task performance. Higher scores indicate better cognitive function.
Time frame
Baseline assessment (before 15 days of smartphone task completion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov