Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users (NCT04154111) | Clinical Trial Compass
CompletedNot Applicable
Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users
United States147 participantsStarted 2020-05-26
Plain-language summary
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.
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 21- 75.
✓. Meets the DSM V criteria for having a current AUD, determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.
✓. Has an AUDIT score above 8 (such that they are at least Medium Risk drinkers according to criteria).
Exclusion criteria
✕. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report.
✕. 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.
✕. Has current suicidal ideation or homicidal ideation.
✕. Is currently taking or initiates a medication known to affect alcohol intake and/or craving (e.g., disulfiram. naltrexone, acamprosate, topiramate). \[Note: This exclusionary criterion is for scientific rather than safety or patient comfort reasons\].
✕. Expects a change in their medical history in the next 6 months that would impair their participation in this study \[e.g. expected medical procedure, planned pregnancy, initiation of new medication\].
What they're measuring
1
Percent days abstinent
Timeframe: Through study completion, up to 4 month follow-up
2
Percentage of heavy drinking days
Timeframe: Through study completion, up to 4 month follow-up
✕. 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.
✕. Suffers from chronic migraines (more than 50% of the days in a month).
✕. Does not meet safety criteria for MRI and TMS