At a glance
ClinicalIndex Comparison Record- ✓Age 21–65 years
- ✓Alcohol use disorder identification test (AUDIT) score >7
- ✓Consumption of ≥20 standard-sized alcoholic drinks per week
- ✕Current use of prescription or illicit psychoactive drugs (except marijuana or nicotine) known to decrease seizure threshold within 30 days
- ✕Current substance use disorder for any substance other than alcohol, marijuana, or nicotine
- ✕Active suicidal or homicidal ideation
- ✕Current breath alcohol concentration >0.002
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Dorsolateral Prefrontal Cortex Theta Burst Stimulation on Alcohol Cue Reactivity and Cognitive Control: a Double-blind, Sham Controlled Study of Heavy Alcohol Drinkers With a History of Alcohol Related Injury.
In Brief
A clinical study evaluating Real iTBS to the dlPFC and Sham iTBS to the dlPFC for Alcohol Drinking and 4 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed Summary
Alcohol Use Disorder (AUD) is prevalent, devastating, and difficult to treat. The intransigence of AUD is readily apparent in the Trauma Unit of Wake Forest University Baptist Hospital, wherein 23% of trauma related admissions are associated with alcohol - higher than the national average of 16%. Of these trauma related admissions, over 70% are estimated to have AUD and 41% will be likely be admitted to the trauma unit again within 5 years. While Dr. Veach (Co-Investigator) and her team in the Department of Surgery have demonstrated that a brief counseling intervention on the inpatient trauma unit can decrease morbidity and recidivism, the rates of AUD and relapse to drinking among these individuals remains very high. With a growing knowledge of the neural circuits that contribute to relapse in AUD, there is an emerging interest in developing a novel, neural-circuit specific therapeutic tool to enhance AUD treatment outcomes. This will be achieved through a double-blind, sham-controlled cohort study in heavy alcohol drinkers with a history of alcohol-related injury. The brain reactivity to alcohol cues (Incentive Salience) and cognitive performance in the presence of an alcoholic beverage cue (Cognitive Control) will be measured immediately before and after participants receive real or sham intermittent theta burst stimulation (iTBS- a potentiating form of transcranial magnetic stimulation (TMS)) to the dorsolateral prefrontal cortex (dlPFC iTBS). The goals of this pilot study are to quantify the acute effect of a single session of real or sham dlPFC iTBS on brain response to alcohol cues (Aim 1) and cognitive flexibility in the presence of an alcohol cue (Aim 2) among risky drinkers (target engagement ).
Study Details
Timeline
Interventions
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).