Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410196
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-03
Brief Title:
Mood and Decision-making in Methamphetamine Use Disorder
Sponsor:
Laureate Institute for Brain Research Inc
Organization:
Laureate Institute for Brain Research Inc
Study Overview
Official Title:
Modulating Explore-exploit Biases by Improving Mood in Adults With Methamphetamine Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MDM-MUD
Brief Summary:
In this project the investigators examine behavior and associated brain activity during explore-exploit decision-making tasks performed pre- and post-modulation of affective state using autobiographical memory recall The investigators hypothesize that a positive memory recall will reduce negative affective state reduce explore-exploit biases and normalize the associated brain activity The investigators propose a randomized double-blind sham-controlled trial of positive autobiographical memory recall with 80 adults n40 per arm with methamphetamine use disorder MUD currently involved in abstinence only treatment centers
Detailed Description:
The growing epidemic of methamphetamine use disorder MUD is a significant burden on public health with surging overdose deaths high likelihood of relapse and current lack of approved medication to treat the disorder When it comes to decision-making individuals with MUD often prioritize drug over non-drug rewards despite negative life consequences in addition they may not sufficiently explore all available choices to exploit the best one in other words make the optimal choice leading to positive consequences Therefore the explore-exploit trade-off is often dysfunctional in MUD Decision-making imbalances in the explore-exploit trade-off may extend well into abstinence a period marked by a negative affective state low mood high depression and anxiety withdrawal which in turn triggers heightened craving and subsequent drug use urges The insula anterior cingulate cortex and striatum are crucial brain regions involved in explore-exploit behaviors and affective state signaling that have also been linked to drug reward processing in MUD We propose that reducing negative affective state improving mood could help normalize explore-exploit behaviors and the response of these brain areas in individuals currently abstinent from methamphetamine and other drugs This project will use a non-drug-related autobiographical memory recall to improve the mood of individuals with MUD and measure whether it normalizes non-drug decision-making using a functional magnetic resonance imaging-based 3-arm bandit task and a behavioral contextual reinforcement learning task A mixed experimental design in n80 72 completers assuming 10 attrition allows the identification of a between-subjects effect of positive n40 36 completers vs neutral n40 36 completers mood modulation and assess the within-subject impact on explore-exploit behaviors pre- versus post-mood modulation Mood groups will be compared on positive and negative affect and behavioralbrain responses to reward valuation outcomes and learning rates
The overarching goal is to establish that improving mood in individuals with MUD can reduce their negative affective state normalize outcome sensitivity in key brain regions and associated learning and reduce the influence of drug rewards on the valuation of non-drug rewards This approach of this proposal embodies the goals of the NIH RDoC Initiative and the NeuroMAP Center by identifying an actionable disease-modifying target mood and studying its effect on the cognitive and neural dysfunction underlying a specific cognitive process explore-exploit behaviors relevant to MUD and possibly other related neuropsychiatric disorders By targeting the intertwined mechanisms between negative affect and explore-exploit biases innovative effective intervention strategies for MUD may be unveiled addressing a critical public health challenge
The overarching goal is to establish that improving mood in individuals with MUD can reduce their negative affective state normalize outcome sensitivity in key brain regions and associated learning and reduce the influence of drug rewards on the valuation of non-drug rewards This approach of this proposal embodies the goals of the NIH RDoC Initiative and the NeuroMAP Center by identifying an actionable disease-modifying target mood and studying its effect on the cognitive and neural dysfunction underlying a specific cognitive process explore-exploit behaviors relevant to MUD and possibly other related neuropsychiatric disorders By targeting the intertwined mechanisms between negative affect and explore-exploit biases innovative effective intervention strategies for MUD may be unveiled addressing a critical public health challenge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P20GM121312 | NIH | None | httpsreporternihgovquickSearchP20GM121312 |