Alcohol Use Disorder Clinical Trial
Official title:
Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users
There is growing interest in the utilization of transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing alcohol use among treatment-seeking individuals with Alcohol Use Disorder (AUD). The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy drinking days) as well as alcohol cue-reactivity in a 4 month period. These data will pave the way for TMS to be used as an innovative, new treatment option for individuals with AUD.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | August 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria 1. Age 21- 75. 2. Meets the DSM V criteria for having a current AUD, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V. 3. Has an AUDIT score above 8 (such that they are at least Medium Risk drinkers according to criteria). Exclusion Criteria: 1. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report. 2. Meets DSM V criteria for schizoaffective disorder. [Note: The inclusion of subjects with 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. 3. Has current suicidal ideation or homicidal ideation. 4. Is currently taking or initiates a medication known to affect alcohol intake and/or craving (e.g., disulfiram. naltrexone, acamprosate, topiramate). [Note: This exclusionary criterion is for scientific rather than safety or patient comfort reasons]. 5. Expects a change in their medical history in the next 6 months that would impair their participation in this study [e.g. expected medical procedure, planned pregnancy, initiation of new medication]. 6. Females of childbearing potential who are pregnant (by urine HCG), planning to become pregnant, nursing, or who are not using a reliable form of birth control. 7. Suffers from chronic migraines (more than 50% of the days in a month). 8. Does not meet safety criteria for MRI and TMS 9. Is at elevated risk of seizure (i.e., has a history of seizures, is currently prescribed medications known to lower seizure threshold and has had a change in their medication). 10. Is currently enrolled in another form of treatment for alcohol use disorder (This is for scientific reasons to clarify the role of TMS as a treatment agent) 11. History of traumatic brain injury resulting in hospitalization, loss of consciousness for more than 10 minutes, and/or having ever been informed he/she has an epidural, subdural, or subarachnoid hemorrhage. 12. Not able to read and understand questionnaires, assessments, and the informed consent. 13. Clinical Intake Withdrawal Assessment (CIWA) >5 (to prevent delivering TMS to individuals in withdrawal. |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent days abstinent | These outcomes will be measured with urine ETG and CDT drug screens collected monthly up to 4 months. | Through study completion, up to 4 month follow-up | |
Primary | Percentage of heavy drinking days | The percentage of heavy drinking days will be measured by timeline follow-back. Individuals will be asked to track their daily alcohol consumption over the course of the study. | Through study completion, up to 4 month follow-up | |
Secondary | Changes in Craving | Additional craving assessments will be measured through the study as well to detect any changes in craving for alcohol. The alcohol urge questionnaire will be asked prior to TMS administration and at the follow-up visits. This is a scale based on the individuals craving at that moment on a scale of 1-7. | Baseline visit, 1-4 month follow-ups | |
Secondary | Neuroimaging outcomes: change in drug cue reactivity as specified by changes in BOLD signal | The effect of real vs. sham TBS to the left dlPFC vs. real vs. sham TBS to the left vmPFC as a tool to modulate the brain response to alcohol cues will be measured using functional MRI BOLD signal and comparing the relative brain reactivity to the alcohol cues in the executive circuit and limbic circuit before and after TMS. | Baseline visit and 1 month follow-up |
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