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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Aug 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with Alcohol Use Disorder (AUD) using a technique called theta burst stimulation (TBS), which is a type of transcranial magnetic stimulation (TMS). TBS uses magnetic pulses to gently stimulate specific parts of the brain without any surgery or anesthesia. The goal of this study is to see if TBS can help reduce the desire to drink alcohol and lessen the brain's reaction to alcohol-related images, which could help people make healthier choices about drinking.

To participate in this trial, individuals need to be between the ages of 21 and 65 and have been diagnosed with Alcohol Use Disorder, which means they drink significantly more than the recommended limits and experience heavy drinking days. Participants will be screened for other health conditions and medications to ensure safety during the trial. If eligible, they can expect to undergo TBS treatment while being monitored and to complete some questionnaires about their drinking habits and feelings. This study is currently recruiting participants, so it's a great opportunity for those looking for new ways to manage their alcohol use.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.