Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643988
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Autobiographical Memory in Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neurobiological Correlates of Autobiographical Memory Training to Improve Opioid Use Disorder Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAMO
Brief 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 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 ones 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 ie 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 cuesreminders 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 eg 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 brains 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 ie the time fluctuation between heartbeats may contribute to deficits in AM and reward flexibility and be a marker of MemFlex treatment success
Autobiographical memory and OUD
AMs are episodic memories of ones 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 ie 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 cuesreminders 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 eg 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 brains 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 ie the time fluctuation between heartbeats may contribute to deficits in AM and reward flexibility and be a marker of MemFlex treatment success
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None