Using brain stimulation to reduce alcohol cravings
MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience
NA · Medical University of South Carolina · NCT04998916
This study is testing if a type of brain stimulation can help people with alcohol use disorder reduce their cravings and drinking behavior.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04998916 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of theta burst stimulation (TBS) applied to the medial prefrontal cortex (mPFC) on individuals with alcohol use disorder (AUD). Participants will undergo 36 sessions of either real or sham TBS over four weeks to assess changes in their drinking behavior and brain responses to alcohol-related cues. The study is designed as a double-blind, placebo-controlled, randomized trial, ensuring that neither the participants nor the researchers know who receives the active treatment. The ultimate goal is to determine if TBS can serve as an effective non-invasive treatment option for reducing alcohol consumption and cravings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 with a diagnosis of alcohol use disorder who consume a significant amount of alcohol weekly.
Not a fit: Patients with a history of seizures, severe alcohol withdrawal, or those with metal implants above the neck may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for individuals struggling with alcohol use disorder.
How similar studies have performed: While this approach is innovative, previous studies have shown promise in using brain stimulation techniques for addiction treatment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Lisa M McTeague
- Email: mcteague@musc.edu
- Phone: 842-792-8274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcohol Use Disorder, Alcohol Drinking, Substance Use, Drinking, Alcohol, Transcranial Magnetic Stimulation, Medial Prefrontal Cortex, Brain Stimulation, Non-invasive