Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder
NCT Number: NCT06577454
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Healthy Volunteers
Interventions: DEVICE: TMS (MagVenture MagPro 100 with MagOption)
Sponsor: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-10
Completion Date: 2027-08-06
Locations: National Institute on Drug Abuse, Baltimore, Maryland, 21224, United States

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.

Primary Outcome Measures: Determine neural correlates of risk and ambiguity tolerance in healthy controls and people with OUD., Preliminary works demonstrates that neural correlates of risk and ambiguity tolerance are separable, 1-3 months|Measure the impact of transcranial magnetic stimulation (TMS) on ambiguity tolerance in healthy controls and people with OUD, TMS has been used to modulate brain activity in areas associated with decision-making, 1-3 months
Secondary Outcome Measures: Determine the impact of TMS on resting-state brain activity, There is evidence that resting state brain organization/function influences task activation. Whether TMS impacts resting state networks associated will be tested., 1-3 months|Determine the impact TMS on outcomes that are relevant to substance use and relapse (e.g., craving), TMS has been shown to modulate clinical endpoints associated with drug use. The influence of TMS on craving will be evaluated., 1-3 months