Mitigating the Disinhibiting Effects of Alcohol With Transcranial Magnetic Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Inhibition Failures (p-failures)
研究概览
简要总结
The goal of this clinical trial is to learn how a specific type of brain stimulation affects alcohol-related decision-making and self-control in adults who drink alcohol. The main questions the study aims to answer are:
- Does brain stimulation change how people behave after drinking alcohol?
- Does the combination of alcohol and different types of brain stimulation affect people's ability to make thoughtful decisions or resist impulses?
Researchers will compare the effects of two types of brain stimulation, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), after people drink alcohol or a placebo drink. A sham (placebo) stimulation condition will also be included. The study uses a within-person design, which means each participant will take part in all conditions.
Participants will:
- Attend five separate study visits
- Drink either an alcoholic or placebo beverage
- Receive one of the brain stimulation conditions (real or sham)
- Complete decision-making tasks before and after drinking
The tasks will measure things like impulsive choices and reaction time. The researchers hope this study will help identify how brain stimulation could be used to improve decision-making during intoxication, which might one day reduce harmful drinking behaviors or prevent alcohol-related accidents.
详细描述
This study aims to understand how brain stimulation affects decision-making and behavioral control after alcohol consumption. Many harmful events related to alcohol use are the result of impaired decision-making while intoxicated. Although there are medications that reduce alcohol cravings, there are few tools available to reduce the negative behavioral effects of alcohol once someone has already consumed it.
This clinical trial uses non-invasive brain stimulation, known as transcranial magnetic stimulation (TMS), to target a brain area called the prefrontal cortex, which helps regulate decision-making and self-control. TMS can increase or decrease activity in targeted brain areas using magnetic pulses. Two specific types of stimulation will be tested:
- iTBS (intermittent theta burst stimulation): typically increases brain activity
- cTBS (continuous theta burst stimulation): typically decreases brain activity
Participants will be healthy adults who report regularly drinking alcohol. Each participant will attend five sessions in a randomized, within-subject design. Across the sessions, participants will experience each of the following conditions:
- Alcohol + iTBS
- Alcohol + cTBS
- Placebo drink + iTBS
- Placebo drink + cTBS
- Alcohol + sham (placebo) stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a study with five experimental conditions that are combinations of alcohol (real, placebo) and brain stimulation (real and sham). The participant will be blinded to all alcohol conditions (alcohol = single blind). The participant and experimenter will be blinded to the brain stimulation condition (TMS = double blinded).
入排标准
- 年龄范围
- 21 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-29
- •Must be competent in English
- •BMI between 19 and 26
- •At least a high school education
- •Moderate alcohol users (e.g., at least occasional alcohol use, without meeting criteria for alcohol use disorder)
- •Negative urine drug screen for illicit drugs
- •Negative urine pregnancy test (if applicable) on testing days
排除标准
- •History of seizures or a first-degree relative with seizure history
- •History of head trauma or other CNS injuries
- •Current or past psychiatric disorders (including substance use disorder, except nicotine or caffeine)
- •Contraindications for non-invasive brain stimulation (e.g., metal implants, pacemaker)
- •Currently pregnant or breastfeeding
- •Current use of medications that lower seizure threshold
- •Positive alcohol withdrawal symptoms
- •Smokes more than five cigarettes per day (to avoid acute nicotine effects or withdrawal during visits)
研究组 & 干预措施
Active alcohol
Participants consume a real alcoholic beverage (ethanol diluted 1:3 with soda, consumed over 10 minutes) designed to produce a peak BAC of ~0.08%
Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.
干预措施: Intermittent Theta Burst Stimulation (Device)
Active alcohol
Participants consume a real alcoholic beverage (ethanol diluted 1:3 with soda, consumed over 10 minutes) designed to produce a peak BAC of ~0.08%
Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.
干预措施: Continuous Theta Burst Stimulation (Device)
Active alcohol
Participants consume a real alcoholic beverage (ethanol diluted 1:3 with soda, consumed over 10 minutes) designed to produce a peak BAC of ~0.08%
Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.
干预措施: Sham Transcranial Magnetic Stimulation (Device)
Placebo alcohol
Participants consume a placebo beverage matched in volume and appearance to the alcoholic beverage, but without an intoxicating dose (soda with alcohol misted on top to simulate scent, consumed over 10 minutes).
Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.
干预措施: Intermittent Theta Burst Stimulation (Device)
Placebo alcohol
Participants consume a placebo beverage matched in volume and appearance to the alcoholic beverage, but without an intoxicating dose (soda with alcohol misted on top to simulate scent, consumed over 10 minutes).
Each session includes baseline task performance, TMS delivered at estimated peak blood alcohol concentration, and follow-up testing to assess changes in impulsivity. This within-subject crossover design allows each participant to serve as their own control to isolate TMS effects.
干预措施: Continuous Theta Burst Stimulation (Device)
结局指标
主要结局
Change in Inhibition Failures (p-failures)
时间窗: Measured at baseline, immediately after the second TMS session at peak BAC (~0.08%), and again on the descending limb of BAC (~0.05%) (approximately 3 hours total)
Change in the proportion of inhibition failures (p-failures) on the cued Go/NoGo task from baseline to post-intervention under each experimental condition. Higher p-failure rates reflect poorer inhibitory control. This outcome will be measured following each TMS and alcohol condition (iTBS, cTBS, sham × active or placebo alcohol), and assessed across timepoints (peak Blood Alcohol Concentration (BAC) \~0.08% and descending BAC \~0.05%).
次要结局
- Reaction Time on Go Trials(Measured at baseline, at peak BAC, and on the descending limb of BAC (approximately 3 hours total))
- Change in Blood Alcohol Concentration-related Task Performance(Assessed within-session at peak and descending BAC (approximately 3 hours total))
研究者
Michael J. Wesley, PhD
Associate Professor
University of Kentucky