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N/A N=11 Randomized Double-blind Basic Science

Effect of Theta Burst Stimulation on Alcohol Cue Reactivity

Alcohol Drinking · Alcohol Use Disorder · Trauma Injury · Alcohol Dependence · Alcohol Abuse

Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Behavioral Outcomes: Change in the k-Value, a Measure of Delay Discounting of Alcohol — -0.12; -7.42 Change in k-value

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Real iTBS to the dlPFC (Device); Sham iTBS to the dlPFC (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Apr 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Behavioral Outcomes: Change in the k-Value, a Measure of Delay Discounting of Alcohol
-0.12; -7.42

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 ).

Eligibility Criteria

Inclusion Criteria

  • Ages 21-65.
  • Alcohol use disorder identification test score >7
  • Drink at least 20 standard sized alcohol beverage servings per week

Exclusion Criteria

  • Current use of prescription or illicit psychoactive drugs (except marijuana or nicotine) known to decrease seizure threshold by self-report in the last 30 days.
  • Currently meets DSM-V criteria for substance use disorder for a substance other than alcohol, marijuana, or nicotine.
  • Has current suicidal or homicidal ideation.
  • Current breath alcohol concentration >0.002
  • Not currently at risk for withdrawal, as indicated by CIWA-Ar >5.
  • History of seizures or seizure disorder(s).
  • 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.
  • Any other violation of MRI/TMS safety measures.
  • Unable to read and understand questionnaires, assessments, and the informed consent.
  • No presence of metal objects in the head/neck.
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04223154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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