NCT04998916 MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience
| NCT ID | NCT04998916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2021-07-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2021-07-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04998916 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04998916 currently recruiting?
Yes, NCT04998916 is actively recruiting participants. Contact the research team at mcteague@musc.edu for enrollment information.
Where is the NCT04998916 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT04998916 clinical trial?
NCT04998916 is sponsored by Medical University of South Carolina. The trial plans to enroll 86 participants.