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NCT04223154 · ClinicalTrials.gov registry record · NA
Effect of Theta Burst Stimulation on Alcohol Cue Reactivity
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04223154: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT04223154 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04223154, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study 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 ).
Primary Outcome
This outcome measure rates the change in k-value, or the delay discounting value of alcohol compared at baseline vs 1 hour after the intervention. Delay discounting is the tendency to place less value on rewards that are delayed in time. K typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and a preference for delayed rewards, and higher values indicating stronger discounting and a preference for immediate rewards.
Interventions
- DEVICE Real iTBS to the dlPFC
- DEVICE Sham iTBS to the dlPFC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-08-26 |
| Est. Completion | 2021-04-16 |
| Phase | NA |
What the finished NCT04223154 record still lists
NCT04223154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Real iTBS to the dlPFC is the first listed.
NCT04223154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04223154 about?
NCT04223154 is a clinical study titled "Effect of Theta Burst Stimulation on Alcohol Cue Reactivity". 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...
What is the current status of trial NCT04223154?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2020-08-26. Estimated completion is 2021-04-16.
What interventions are being tested in trial NCT04223154?
The interventions under investigation include: Real iTBS to the dlPFC (DEVICE), Sham iTBS to the dlPFC (DEVICE).
Who is sponsoring clinical trial NCT04223154?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04223154's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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