Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577454
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08-16
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:
None
Brief Summary:
Background
The purpose of this study is to understand how a type of brain stimulation transcranial magnetic stimulation TMS may help those who use opioids such as heroin or methadone TMS uses brief magnetic pulses to affect brain activity and is approved by the FDA to treat some mental health problems and substance use We will evaluate how TMS may help make it easier to make certain kinds of decisions that could help one manage their opioid use Our findings may provide support for the use of brain stimulation as a treatment to reduce opioid use
Objective
To understand how TMS affects brain activity associated with decision making in people who do and do not use opioids
Eligibility
People aged 18 to 60 years with an OUD Healthy volunteers are also needed
Design
Participants will have up to 3 clinic visits over 1 to 3 months
All participants will be screened to check if they are eligible to take part in this study This study is completed in two parts All eligible participants will complete the first part of the study In the first part you will receive one baseline magnetic resonance imaging MRI scan so we can take pictures of your brain while you complete computer tasks in the scanner In these tasks you will be asked to identify colors of words view different images and play a game in which you can win money If you can safely receive TMS you will be invited to complete the second part of the study In this part of the study you will receive TMS and MRI over 2 sessions For TMS a coil will be placed on your head and a short electrical current will pass through the coil to create a magnetic pulse that stimulates your brain You will also repeat the MRI scan and computer tasks During one of the TMS visits you will receive active or real TMS In the other you will receive sham or placebo TMS which feels like real TMS but does not affect the brain You will receive both types of TMS In all sessions your urine and breath will be tested for drugs and alcohol and you will complete questionnaires about mood and health
The purpose of this study is to understand how a type of brain stimulation transcranial magnetic stimulation TMS may help those who use opioids such as heroin or methadone TMS uses brief magnetic pulses to affect brain activity and is approved by the FDA to treat some mental health problems and substance use We will evaluate how TMS may help make it easier to make certain kinds of decisions that could help one manage their opioid use Our findings may provide support for the use of brain stimulation as a treatment to reduce opioid use
Objective
To understand how TMS affects brain activity associated with decision making in people who do and do not use opioids
Eligibility
People aged 18 to 60 years with an OUD Healthy volunteers are also needed
Design
Participants will have up to 3 clinic visits over 1 to 3 months
All participants will be screened to check if they are eligible to take part in this study This study is completed in two parts All eligible participants will complete the first part of the study In the first part you will receive one baseline magnetic resonance imaging MRI scan so we can take pictures of your brain while you complete computer tasks in the scanner In these tasks you will be asked to identify colors of words view different images and play a game in which you can win money If you can safely receive TMS you will be invited to complete the second part of the study In this part of the study you will receive TMS and MRI over 2 sessions For TMS a coil will be placed on your head and a short electrical current will pass through the coil to create a magnetic pulse that stimulates your brain You will also repeat the MRI scan and computer tasks During one of the TMS visits you will receive active or real TMS In the other you will receive sham or placebo TMS which feels like real TMS but does not affect the brain You will receive both types of TMS In all sessions your urine and breath will be tested for drugs and alcohol and you will complete questionnaires about mood and health
Detailed Description:
Study Description
Risky decision-making is a core feature of substance use disorders and contributes to the compulsive behaviors seen in opioid use disorder OUD Risky decision-making can be separated into two distinct components tolerance for known risks and tolerance for unknown ambiguous risks Tolerance for ambiguity in decision-making has been associated with increased risk of relapse in OUD however conventional treatments for OUD rarely consider and target the dissociable components of decision-making that might underlie risky behaviors In this study we will utilize connectivity-based transcranial magnetic stimulation to selectively modulate ambiguity tolerance in decision-making in people with an OUD Individualized cortical targets for stimulation will be derived from a baseline measurement of decision-making capacity The ability for transcranial magnetic stimulation TMS to modulate ambiguity tolerance in decision-making will be assessed relative to placebo stimulation as well as clinical correlates such as craving
Objectives
Primary Objectives
Determine neural correlates of risk and ambiguity tolerance in healthy controls and people with OUD
Measure the impact of a type of TMS theta burst stimulation on ambiguity tolerance in healthy controls and people with OUD
Secondary Objectives
Determine the impact of TMS on resting-state brain activity
Determine the impact TMS on outcomes that are relevant to substance use and relapse eg craving
TertiaryExploratory Objectives
The effect of sex on the above metrics will be explored
Endpoints
The impact of transcranial magnetic stimulation on decision making will be assessed several ways
Primary Endpoints
Brain reactivity during decision-making task that separates tolerance for risk and tolerance for ambiguity
Modulation of behavior and neural activity in areas of the brain associated with ambiguity tolerance by TMS
Secondary Endpoints
The influence of TMS on the brain s resting state function will be assessed
The influence of TMS on substance use-related outcomes will be assessed
TertiaryExploratory Endpoints
Completion of baseline visit where neuromodulation is not administered
Risky decision-making is a core feature of substance use disorders and contributes to the compulsive behaviors seen in opioid use disorder OUD Risky decision-making can be separated into two distinct components tolerance for known risks and tolerance for unknown ambiguous risks Tolerance for ambiguity in decision-making has been associated with increased risk of relapse in OUD however conventional treatments for OUD rarely consider and target the dissociable components of decision-making that might underlie risky behaviors In this study we will utilize connectivity-based transcranial magnetic stimulation to selectively modulate ambiguity tolerance in decision-making in people with an OUD Individualized cortical targets for stimulation will be derived from a baseline measurement of decision-making capacity The ability for transcranial magnetic stimulation TMS to modulate ambiguity tolerance in decision-making will be assessed relative to placebo stimulation as well as clinical correlates such as craving
Objectives
Primary Objectives
Determine neural correlates of risk and ambiguity tolerance in healthy controls and people with OUD
Measure the impact of a type of TMS theta burst stimulation on ambiguity tolerance in healthy controls and people with OUD
Secondary Objectives
Determine the impact of TMS on resting-state brain activity
Determine the impact TMS on outcomes that are relevant to substance use and relapse eg craving
TertiaryExploratory Objectives
The effect of sex on the above metrics will be explored
Endpoints
The impact of transcranial magnetic stimulation on decision making will be assessed several ways
Primary Endpoints
Brain reactivity during decision-making task that separates tolerance for risk and tolerance for ambiguity
Modulation of behavior and neural activity in areas of the brain associated with ambiguity tolerance by TMS
Secondary Endpoints
The influence of TMS on the brain s resting state function will be assessed
The influence of TMS on substance use-related outcomes will be assessed
TertiaryExploratory Endpoints
Completion of baseline visit where neuromodulation is not administered
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