Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users
Completed · Not applicable · Has a placebo group
Conditions studied: Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence, Craving
In brief
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.
Key facts
- Study ID
- NCT04154111
- Run by
- Wake Forest University Health Sciences
- People needed
- 147
- Starts
- 2020-05-26
- Expected to finish
- 2026-02-09
- Last updated by the study team
- 2026-06-02
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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].
- 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
- 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).
- 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)
- 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.
- Not able to read and understand questionnaires, assessments, and the informed consent.
- Clinical Intake Withdrawal Assessment (CIWA) >5 (to prevent delivering TMS to individuals in withdrawal.
Where it is running
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.