iTBS for Alcohol Use Disorder

Launched by NICHOLAS BALDERSTON, PHD · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called intermittent theta-burst stimulation (iTBS) to see if it can help individuals with Alcohol Use Disorder (AUD) change their behavior and reduce the risk of relapse. Participants will be randomly assigned to receive either iTBS or a sham (placebo) treatment while they are exposed to alcohol-related cues. The goal is to understand how iTBS affects brain responses and behaviors related to alcohol use. This study will take place over five days, with four treatment sessions each day.

To be eligible for this trial, participants must be between the ages of 21 and 75, right-handed, and seeking treatment for AUD at Caron Treatment Centers for at least 28 days. They also need to agree to follow study procedures and provide informed consent. However, certain individuals, including those with significant neurological disorders, certain medical devices, or a history of severe psychiatric issues, may not be eligible to participate. If you join the trial, you can expect to undergo brain response measurements while participating in tasks designed to assess your reactions to alcohol cues, which may help researchers learn more about effective treatments for AUD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form.
• • 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
• • 3. Male or female, aged \>21and \<75
• • 4. Right-handed
• • 5. Diagnosed with an AUD disorder seeking treatment at Caron Treatment Centers and planning to be enrolled in residential treatment for a minimum of 28 days.
• • 6. Ability to obtain an MT at the first session.
• • 7. Women of childbearing potential must consent to use a medically accepted method of birth control (e.g., implants, injectables, oral contraceptives, IUD, sexual abstinence, or vasectomized partner) or to abstain from sexual intercourse only during the five treatment days of the study.
• Exclusion Criteria:
• • 1. Age \<21 or \>75 years.
• • 2. Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.
• • 3. Evidence or history of a significant neurological disorder including moderate-severe head trauma, stroke, Parkinson's disease, or other movement disorder (except benign essential tremor), epilepsy. History of seizures (except juvenile febrile seizures or any condition/concurrent medication that could notably lower seizure threshold. This may include traumatic brain injury (TBI) if the TBI places the individual at an elevated risk of seizure.
• • 4. Have a cardiac pacemaker.
• • 5. Have an implanted device or metal in the brain.
• • 6. Have a cochlear implant.
• • 7. Have a current amnestic disorder, delirium, or other cognitive disorder.
• • 8. Previous treatment with TMS.
• • 9. Left-handed
• • 10. Suicidal ideation within the past month, or history of suicide attempt(s) within the past year.
• • 11. Active psychosis or history of severe psychiatric disorder with psychosis or unstable or untreated psychiatric disorder with potential for psychosis.
• • 12. Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by a study physician.
• • 13. Diagnoses of severe depression or bipolar disorder.
• • 14. Anyone who in the opinion of the principal investigator (PI) or study physician would not be appropriate for participation (i.e., behavioral issues during clinical treatment, clinical needs outweighing research participation).