RECRUITING

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Conditions

Alcohol Use Disorder Alcohol Drinking Substance Use Drinking, Alcohol Alcohol Use Disorder (AUD)Transcranial Magnetic Stimulation Medial Prefrontal Cortex Brain Stimulation Non-invasive Adult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Official Title

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Quick Facts

Study Start:2021-07-06

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04998916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the demonstrated effect50 on TMS-fMRI responses in addiction) * Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V * Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling. * Able to read and understand questionnaires and informed consent.	* Has metal placed above the neck * Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold) * Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal * Has a history of claustrophobia * Has a history of chronic migraines * Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage * Has an unstable medical illness requiring planned medical/surgical intervention (e.g. chemotherapy, surgical procedure) * Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric/sleeping medications except for stable (1 month) antidepressants/SSRI's. \[Note: this criterion is for scientific rather than safety or patient comfort reasons\]. * Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months * Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. \[Note: The inclusion of participants with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large\] * Has current suicidal ideation or homicidal ideation * Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.

Inclusion Criteria

Exclusion Criteria

* Age 21-65 (to maximize participation; note: Scalp-to-Cortex distance will be included as a covariate to calculate adjusted TMS dose given expected cortical atrophy in heavy alcohol users and older adults and the demonstrated effect50 on TMS-fMRI responses in addiction)
* Alcohol Use Disorder, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V
* Consumption of more than 14 drinks (women) or 21 drinks (men) per week, with at least 4 heavy drinking days (defined as ≥ 4 drinks for women and ≥ 5 for men) per week during the 30-days prior to enrolling.
* Able to read and understand questionnaires and informed consent.

* Has metal placed above the neck
* Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold)
* Has a history of moderate to severe alcohol withdrawal or medicated alcohol withdrawal
* Has a history of claustrophobia
* Has a history of chronic migraines
* Has a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage
* Has an unstable medical illness requiring planned medical/surgical intervention (e.g. chemotherapy, surgical procedure)
* Medications: Is currently taking or initiates a new prescription for drugs known to improve alcohol drinking treatment outcomes (e.g. naltrexone, acamprosate, topiramate) or taking psychiatric/sleeping medications except for stable (1 month) antidepressants/SSRI's. \[Note: this criterion is for scientific rather than safety or patient comfort reasons\].
* Has a history of substance use disorder (other than nicotine) by DSM-V criteria in the past 6 months
* Meets DSM V criteria for panic disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, dissociative disorders, eating disorders, and any other psychotic disorder. \[Note: The inclusion of participants with other affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with AUD at large\]
* Has current suicidal ideation or homicidal ideation
* Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.

Contacts and Locations

Study Contact

Lisa M McTeague

CONTACT

842-792-8274

mcteague@musc.edu

Rhia Walton

CONTACT

842-792-8274

waltonrh@musc.edu

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29401

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-06

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-07-06

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Transcranial Magnetic Stimulation
Medial Prefrontal Cortex
Brain Stimulation
Non-invasive
Adult

Additional Relevant MeSH Terms

Alcohol Use Disorder
Alcohol Drinking
Substance Use
Drinking, Alcohol
Alcohol Use Disorder (AUD)