Opioid Use DisorderNCT07153029
Older Adults, Methadone, and Cognitive Function
A study testing Smartphone based cognitive tasks in people with Opioid Use Disorder and Cognitive Ability General, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Opioid Use Disorder, Cognitive Ability General
- What is being tested?
- Smartphone based cognitive tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 8 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age 54 or younger
- not in methadone treatment for opioid use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UM Addiction Treatment Programs at 1001 West Pratt
Baltimore, Maryland, 21124
About this study
Official title: Cognitive Functioning Among Older Adults in Methadone Treatment for Opioid Use Disorder
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.
Read the 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, adherence, acceptability, and useability will be examined after 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 opioid use disorder treatment. Hypothesis: Patients will demonstrate high adherence (> 70% completed assessments), acceptability (> 70% high satisfaction), and usability (mean score > 68 on the "System Usability Scale").
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). Adherence and acceptability (see Aim 1) during this phase of the task and accuracy on tasks will be examined 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.
- Conditions
- Opioid Use Disorder, Cognitive Ability General
- Being tested
- Smartphone based cognitive tasks
- Keywords
- older adults, cognition, feasibility, ecological momentary assessment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone based cognitive tasksBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Smartphone based cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to smartphone task completion
proportion of completed assessments on the smartphone
Measured: across 15 days of use
Satisfaction with smartphone tasks
Proportion reporting high satisfaction (>70%) with smartphone tasks
Measured: 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.
Measured: 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.
Measured: 15 days of smartphone tasks
Secondary 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.
Measured: 1 month (pre-post 15 day cognitive tasks on smartphone)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start3 Dec 2025
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Bethea A Kleykamp, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153029
- Sponsor's protocol ID
- HP-00116032
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including baseline characteristics and outcome measures, will be shared with qualified researchers upon request. Data will be available after publication of the primary results. Requests will require approval by the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functioning Among Older Adults in Methadone Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07153029
- Acronym / sponsor ID
- HP-00116032
- Conditions
- Opioid Use Disorder, Cognitive Ability General
- Keywords
- older adults, cognition, feasibility, ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, adherence, acceptability, and useability will be examined after 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 opioid use disorder treatment. Hypothesis: Patients will demonstrate high adherence (> 70% completed assessments), acceptability (> 70% high satisfaction), and usability (mean score > 68 on the "System Usability Scale").
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). Adherence and acceptability (see Aim 1) during this phase of the task and accuracy on tasks will be examined 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based assessments and cognitive tasks | Experimental | Behavioral: Smartphone based cognitive tasksAll 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age 54 or younger
- not in methadone treatment for opioid use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone based cognitive tasks15 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. | Behavioural | Smartphone-based assessments and cognitive tasks |
Primary outcome
Adherence to smartphone task completion
Time frame: across 15 days of use
proportion of completed assessments on the smartphone
Satisfaction with smartphone tasks
Time frame: across 15 days of use
Proportion reporting high satisfaction (>70%) with smartphone tasks
Usability of smartphone tasks
Time frame: after 15 days of use
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.
Cognitive Task Performance
Time frame: 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.
1 secondary outcome
Laboratory cognitive functioning
Time frame: 1 month (pre-post 15 day cognitive tasks on smartphone)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including baseline characteristics and outcome measures, will be shared with qualified researchers upon request. Data will be available after publication of the primary results. Requests will require approval by the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone based cognitive tasks in people with Opioid Use Disorder and Cognitive Ability General, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to smartphone task completion (time frame: across 15 days of use). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.