NCT06577454

Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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....

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 (e.g., craving). * Tertiary/Exploratory 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. * Tertiary/Exploratory Endpoints: * Completion of baseline visit where neuromodulation is not administered.

Conditions

• Opioid Use Disorder
• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	TMS (MagVenture MagPro 100 with MagOption)	TMS will be applied using the MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) stimulator with a figure-of-8 TMS coil.

Timeline

• Start date: 2026-04-22
• Primary completion: 2027-08-06
• Completion: 2027-08-06
• First posted: 2024-08-29
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study