RecruitingNot ApplicableNCT04998916

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

Sponsor

Medical University of South Carolina

Enrollment

86 participants

Start Date

Jul 6, 2021

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Inclusion Criteria4

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.

Exclusion Criteria12

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEReal TBS to the mPFC

This will be delivered with the Magventure Magpro system; 600 pulses of continuous theta burst stimulation with the active sham coil (double blinded using the integrated active sham system).

DEVICESham TBS to the mPFC

This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the integrated active sham system). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions.