Opioid Use DisorderNAMONCT06643988
Autobiographical Memory in Opioid Use Disorder
A study testing MemFlex in people with Opioid Use Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
The research study is being conducted to better understand memory function in people with opioid use disorder (OUD) and whether memory training can improve the symptoms and lives of people with OUD. Further, this study seeks to identify how brain and heart activity contribute to memory function and OUD symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- MemFlex
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 years to 60 years old.
- Willingness to provide signed, informed consent and commit to completing study procedures
- Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, and must have access to a cellphone.
- OUD subjects: Lifetime self-reported history of OUD (according to DSM-5 criteria)
- OUD subjects: On a stable dose (at least 2 weeks without change) of MOUD (e.g., buprenorphine, methadone) as confirmed by self-report, urine drug screening, and/or the Prescription Drug Monitoring Program database.
- OUD subjects: Access to a stable residence or space to complete the at-home treatment module
Who cannot join
- Current severe psychiatric (e.g., bipolar disorder) or physical (e.g., dementia, Parkinson's disease) determined by self-reported history or physical exam and disorder deemed by PI to significantly interfere with brain function or make the study hazardous for the subject.
- Head trauma or injury deemed by PI as likely to impact the prefrontal cortex (e.g., loss of consciousness for more than 30 minutes or skull fracture, intracranial bleeding, or abnormal MRI) as determined by self-reported history or physical exam.
- Medical condition or medical treatment that may interfere with the subject's ability to complete the intervention, at discretion of the PI (e.g., extended surgery planned or expecting to give birth during the course of the study)
- Inability to sit upright while remaining relatively still and operating a mouse and keypad.
- Current ongoing participation in a research study or participation in a clinical trial and receipt of investigational drug(s) or intervention during 30 days prior to the research study, except as explicitly approved by the Principal Investigator.
- Currently prescribed opioid medication for treatment of pain or other disorder (besides opioid use disorder).
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- OUD subjects: Past 1-year history of non-OUD substance use disorder (other than nicotine, alcohol, or cannabis use disorders).
- OUD subjects: Positive urine drug screen for any tested substances except for opioids, cocaine, and cannabis at screening or the baseline assessment visit (a test may be repeated if it is needed to confirm accuracy).
- HC subjects: Lifetime history of any substance use disorder (other than nicotine use disorder at any time and alcohol or cannabis use disorders more than 1 year ago).
- HC subjects: Positive urine drug screen for any tested substances at screening or the baseline assessment visit (a test may be repeated if it is needed to confirm accuracy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Megan Ivey, MS, 215-746-7712, megan.ivey@pennmedicine.upenn.edu
Anna Rose Childress, PhD
About this study
Official title: Neurobiological Correlates of Autobiographical Memory Training to Improve Opioid Use Disorder Outcomes
The research study is being conducted to better understand memory function in people with opioid use disorder (OUD) and whether memory training can improve the symptoms and lives of people with OUD. Further, this study seeks to identify how brain and heart activity contribute to memory function and OUD symptoms. Participants will be asked to complete a baseline assessment, four weeks of at-home memory training (MemFlex), and a post-treatment follow-up assessment. Everyone enrolled will receive MemFlex as there is no placebo group. Each visit will include collection of a urine sample for drug testing. During the baseline and follow-up assessments, researchers will collect brain information using functional near-infrared spectroscopy (fNIRS) and heartbeat data using a wearable wristband sensor. MemFlex is a cognitive-behavioral intervention that does not pose any risk. However, the use of MemFlex in this study is experimental as it has not been tested in individuals with OUD. We will enroll 20 participants with OUD and 10 participants meeting healthy volunteer criteria.
Read the detailed description
In this study, we propose to characterize possible OUD-related dysfunction in AM. We will further examine the impact of a cognitive training intervention (Memory Flexibility Training [MemFlex]) on AM and drug use outcomes and explore the underlying brain and physiological mechanisms.
Autobiographical memory and OUD:
AMs are episodic memories of one's own life. Under healthy circumstances, AMs are not simple facts (frozen in time) but are influenced by the current context to help maintain a positive sense-of-self and motivate adaptive behaviors. That is, individuals flexibly focus AM to retrieve details that help with current goals, or they adjust AM-related emotions to assist in current regulation of emotion. Patients across psychiatric disorders often have difficulty recalling specific AMs (i.e., those of a single brief event) and show dysfunction in the vividness and emotionality of AMs. The few studies on AM in OUD indicate these individuals recall fewer specific AMs have easier access to neutral AMs, and less positive AMs.
Memory Flexibility Training:
MemFlex employs cognitive training exercises in self-led sessions to improve 1) switching between specific and general AMs, 2) access to positive AMs, and 3) vividness of positive AMs. In trials for depression and posttraumatic stress, MemFlex has improved symptoms and AM recall but MemFlex has not been tested for OUD. Previous research has shown that chronic drug use can lead to increased dopaminergic brain response to drug reward cues/reminders (which are learned over time) and reduced dopaminergic brain response to receiving both drug and non-drug rewards (in-the-moment). This can create reward inflexibility, in which drug rewards drive motivation while non-drug rewards contribute relatively little. Further, work in our lab and others has shown OUD is associated with cognitive inflexibility, which is an impaired ability to switch between mental tasks when contexts change and may impair decision-making. Inflexibility in the reward and cognitive systems may leave individuals 'stuck' choosing drug rewards to the exclusion of other rewards (e.g., relationships, work). We propose that MemFlex, by improving access to non-drug reward-related AMs and the ability to switch between types of AMs, will help patients with OUD use AM to regulate emotions and pursue healthier rewards.
Neurobiological Foundation of Flexibility:
The brain's prefrontal cortex (PFC) is critical to successful cognitive flexibility and reward function. It is also implicated in AM deficits and is impaired in people with OUD. As such, we will use PFC activity during AM and reward flexibility task may explain the neural foundations of related deficits. Previous research has also shown that physiological arousal, as measured by heart rate variability (HRV), contributes to cognitive flexibility and correlates with PFC and subcortical brain areas that support flexibility. Therefore, HRV (i.e., the time fluctuation between heartbeats) may contribute to deficits in AM and reward flexibility and be a marker of MemFlex treatment success.
- Conditions
- Opioid Use Disorder
- Being tested
- MemFlex
- 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.
MemFlexBehavioural
MemFlex employs cognitive training exercises in self-led sessions to improve 1) switching between specific and general AMs, 2) access to positive AMs, and 3) vividness of positive AMs.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | No intervention | Participants who meet criteria as healthy volunteers, will receive no MemFlex training but will undergo assessments as well as fNIRS computerized tasks. |
| OUD | Experimental | Participants who meet criteria for OUD and are on a stable dose of medication assisted therapy for OUD will be trained in memory flexibility training (MemFlex) - cognitive training exercises. Receives: Behavioral: MemFlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autobiographical Memory (AM) Recall (AMT-AI)
Specificity [specific vs. general] and valence [positive, negative, neutral] and PFC activity during AM recall.The AMT-AI outcomes will be the proportion of specific AMs in each condition (neutral, positive, negative) and mean ΔHbO in the mPFC and dlPFC (separately) during AM recall relative to the control block.
Measured: Pre and Post treatment assessment (weeks 1 and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start19 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643988
- Sponsor's protocol ID
- 856848
- Acronym
- NAMO
- Status last verified
- Jul 2026
- First submitted
- 14 Oct 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Correlates of Autobiographical Memory Training to Improve Opioid Use Disorder Outcomes
- ClinicalTrials.gov ID
- NCT06643988
- Acronym / sponsor ID
- NAMO / 856848
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Oct 2024 (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 research study is being conducted to better understand memory function in people with opioid use disorder (OUD) and whether memory training can improve the symptoms and lives of people with OUD. Further, this study seeks to identify how brain and heart activity contribute to memory function and OUD symptoms. Participants will be asked to complete a baseline assessment, four weeks of at-home memory training (MemFlex), and a post-treatment follow-up assessment. Everyone enrolled will receive MemFlex as there is no placebo group. Each visit will include collection of a urine sample for drug testing. During the baseline and follow-up assessments, researchers will collect brain information using functional near-infrared spectroscopy (fNIRS) and heartbeat data using a wearable wristband sensor. MemFlex is a cognitive-behavioral intervention that does not pose any risk. However, the use of MemFlex in this study is experimental as it has not been tested in individuals with OUD. We will enroll 20 participants with OUD and 10 participants meeting healthy volunteer criteria.
Detailed description
In this study, we propose to characterize possible OUD-related dysfunction in AM. We will further examine the impact of a cognitive training intervention (Memory Flexibility Training [MemFlex]) on AM and drug use outcomes and explore the underlying brain and physiological mechanisms.
Autobiographical memory and OUD:
AMs are episodic memories of one's own life. Under healthy circumstances, AMs are not simple facts (frozen in time) but are influenced by the current context to help maintain a positive sense-of-self and motivate adaptive behaviors. That is, individuals flexibly focus AM to retrieve details that help with current goals, or they adjust AM-related emotions to assist in current regulation of emotion. Patients across psychiatric disorders often have difficulty recalling specific AMs (i.e., those of a single brief event) and show dysfunction in the vividness and emotionality of AMs. The few studies on AM in OUD indicate these individuals recall fewer specific AMs have easier access to neutral AMs, and less positive AMs.
Memory Flexibility Training:
MemFlex employs cognitive training exercises in self-led sessions to improve 1) switching between specific and general AMs, 2) access to positive AMs, and 3) vividness of positive AMs. In trials for depression and posttraumatic stress, MemFlex has improved symptoms and AM recall but MemFlex has not been tested for OUD. Previous research has shown that chronic drug use can lead to increased dopaminergic brain response to drug reward cues/reminders (which are learned over time) and reduced dopaminergic brain response to receiving both drug and non-drug rewards (in-the-moment). This can create reward inflexibility, in which drug rewards drive motivation while non-drug rewards contribute relatively little. Further, work in our lab and others has shown OUD is associated with cognitive inflexibility, which is an impaired ability to switch between mental tasks when contexts change and may impair decision-making. Inflexibility in the reward and cognitive systems may leave individuals 'stuck' choosing drug rewards to the exclusion of other rewards (e.g., relationships, work). We propose that MemFlex, by improving access to non-drug reward-related AMs and the ability to switch between types of AMs, will help patients with OUD use AM to regulate emotions and pursue healthier rewards.
Neurobiological Foundation of Flexibility:
The brain's prefrontal cortex (PFC) is critical to successful cognitive flexibility and reward function. It is also implicated in AM deficits and is impaired in people with OUD. As such, we will use PFC activity during AM and reward flexibility task may explain the neural foundations of related deficits. Previous research has also shown that physiological arousal, as measured by heart rate variability (HRV), contributes to cognitive flexibility and correlates with PFC and subcortical brain areas that support flexibility. Therefore, HRV (i.e., the time fluctuation between heartbeats) may contribute to deficits in AM and reward flexibility and be a marker of MemFlex treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | No intervention | –Participants who meet criteria as healthy volunteers, will receive no MemFlex training but will undergo assessments as well as fNIRS computerized tasks. |
| OUD | Experimental | Behavioral: MemFlexParticipants who meet criteria for OUD and are on a stable dose of medication assisted therapy for OUD will be trained in memory flexibility training (MemFlex) - cognitive training exercises. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 years to 60 years old.
- Willingness to provide signed, informed consent and commit to completing study procedures
- Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, and must have access to a cellphone.
- OUD subjects: Lifetime self-reported history of OUD (according to DSM-5 criteria)
- OUD subjects: On a stable dose (at least 2 weeks without change) of MOUD (e.g., buprenorphine, methadone) as confirmed by self-report, urine drug screening, and/or the Prescription Drug Monitoring Program database.
Key exclusion criteria (10 listed)
- Current severe psychiatric (e.g., bipolar disorder) or physical (e.g., dementia, Parkinson's disease) determined by self-reported history or physical exam and disorder deemed by PI to significantly interfere with brain function or make the study hazardous for the subject.
- Head trauma or injury deemed by PI as likely to impact the prefrontal cortex (e.g., loss of consciousness for more than 30 minutes or skull fracture, intracranial bleeding, or abnormal MRI) as determined by self-reported history or physical exam.
- Medical condition or medical treatment that may interfere with the subject's ability to complete the intervention, at discretion of the PI (e.g., extended surgery planned or expecting to give birth during the course of the study)
- Inability to sit upright while remaining relatively still and operating a mouse and keypad.
- Current ongoing participation in a research study or participation in a clinical trial and receipt of investigational drug(s) or intervention during 30 days prior to the research study, except as explicitly approved by the Principal Investigator.
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 |
|---|---|---|
| MemFlexMemFlex employs cognitive training exercises in self-led sessions to improve 1) switching between specific and general AMs, 2) access to positive AMs, and 3) vividness of positive AMs. | Behavioural | OUD |
Primary outcome
Autobiographical Memory (AM) Recall (AMT-AI)
Time frame: Pre and Post treatment assessment (weeks 1 and 5)
Specificity [specific vs. general] and valence [positive, negative, neutral] and PFC activity during AM recall.The AMT-AI outcomes will be the proportion of specific AMs in each condition (neutral, positive, negative) and mean ΔHbO in the mPFC and dlPFC (separately) during AM recall relative to the control block.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MemFlex in people with Opioid Use Disorder, run by University of Pennsylvania 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Ivey, MS (215-746-7712, megan.ivey@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autobiographical Memory (AM) Recall (AMT-AI) (time frame: Pre and Post treatment assessment (weeks 1 and 5)). 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 10 Jul 2026.