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

NCT06577454 | Suspended FDA Device

• 2 other identifiers: 10001866001866-DA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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....

Conditions

Opioid Use Disorder; Healthy Volunteers

Keywords

Opioid use Disorder; Transcranial Magnetic Stimulation (TMS); Theta Burst Stimulation (TBS); Risky decision-making

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Determine the impact of TMS on resting-state brain activity

  1-3 months

• Determine the impact TMS on outcomes that are relevant to substance use and relapse (e.g., craving)

  1-3 months

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

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.

Device: TMS (MagVenture MagPro 100 with MagOption)

Sham TMS

SHAM COMPARATOR

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.

Device: TMS (MagVenture MagPro 100 with MagOption)

Interventions

TMS (MagVenture MagPro 100 with MagOption) DEVICE

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

Active TMS; Sham TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Both groups:
• Participants will be volunteers between the ages of 18-60.
• Opioid-using group:
• Participants must meet DSM-5 criteria for an opioid use disorder (active or in remission and on maintenance therapy).
• Participants must be currently enrolled in and receiving medication-assisted treatment for opioid use disorder (MOUD; such as methadone, buprenorphine or naltrexone) and report a stable dose of their medication for at least 4 weeks prior to enrollment.\*
• Participants in this group can meet DSM-5 criteria for other substance use disorders (such as alcohol, nicotine, or cocaine use disorder) currently or in the past but must also meet criteria for an OUD.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Controls:
• Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder.
• All participants:
• Participants cannot meet DSM-5 criteria for lifetime and/or current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder.
• Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
• Participants cannot have any history of significant neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics. MAI will use discretion in evaluating the impact of minor events or history reported.
• Participants cannot be pregnant.
• Participants with Major Depressive Disorder (per DSM-V criteria) must be stable on medication(s) for 3 months.
• Subjects with suicidal ideation where outpatient treatment is determined unsafe.
• Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
• Any contraindications to MRI.
• For subjects continuing to the TMS portion of the protocol, contraindications for TMS.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Amy C Janes, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 29, 2024
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): August 6, 2027
• Study Completion (Estimated): August 6, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)