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Active TMS for Healthy Subjects

N/A
Waitlist Available
Led By Kathryn C Biernacki, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-Participants will be volunteers between the ages of 18-60.
* Participants must meet DSM-5 criteria for an opioid use disorder (active or in remission and on maintenance therapy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-3 months
Awards & highlights

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.

Who is the study for?
This trial is for people aged 18 to 60 who either have an opioid use disorder (OUD) or are healthy volunteers. Participants with OUD may be using opioids like heroin or methadone. All participants must pass a screening and be able to safely receive TMS, which will be determined by the study team.
What is being tested?
The study tests how transcranial magnetic stimulation (TMS), a brain stimulation technique, affects decision-making in those with and without OUD. It involves MRI scans while doing computer tasks and two sessions of both real and placebo TMS over one to three months.
What are the potential side effects?
TMS can cause discomfort at the site on the head where it's applied, headaches, lightheadedness, or seizures in rare cases. The sham TMS mimics real TMS but doesn't stimulate the brain; side effects should be minimal if any.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine neural correlates of risk and ambiguity tolerance in healthy controls and people with OUD.
Measure the impact of transcranial magnetic stimulation (TMS) on ambiguity tolerance in healthy controls and people with OUD
Secondary study objectives
Determine the impact TMS on outcomes that are relevant to substance use and relapse (e.g., craving)
Determine the impact of TMS on resting-state brain activity

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active TMSActive Control1 Intervention
Participants will be blinded as to which sessions involve active TMS or sham. Those study staff involved in interacting with the participant will also be blinded. Participants will be randomized into either active-sham or sham-active session order.
Group II: Sham TMSPlacebo Group1 Intervention
Participants will be blinded as to which sessions involve active TMS or sham. Those study staff involved in interacting with the participant will also be blinded. Participants will be randomized into either active-sham or sham-active session order.

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Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,506 Previous Clinical Trials
2,625,903 Total Patients Enrolled
Kathryn C Biernacki, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
~40 spots leftby Aug 2027