Self-activation of Reward-related Brain Regions in Individuals With and Without Nicotine Dependence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Percent Change in Reward-related Brain Activation as Measured by fMRI
研究概览
简要总结
The purpose of this study is to see if a non-medication intervention can increase motivation and reward processing to non-drug reward cues (for example, a picture of one's favorite food) in individuals with and without nicotine dependence by observing brain activity using electroencephalography (EEG) and/or functional magnetic resonance imaging (fMRI). The investigators hypothesize that learning to increase brain activity to non-drug cues may improve reward responses and motivation to non-drug cues, and for individuals who smoke, may eventually result in improved smoking cessation outcomes.
详细描述
The purpose of this study is to:
- Assess the ability of adults with and without nicotine dependence (ND) to activate reward-related brain regions (e.g., ventral tegmental area (VTA), striatum, prefrontal cortex).
- Evaluate whether fMRI and/or EEG neurofeedback improves the ability to increase reward-related brain activation in individuals with and without ND.
- Examine the relationship between activation of reward-related regions via neurofeedback and dopamine availability (as assessed genetically).
- Examine the effects of neurofeedback on clinically relevant outcomes, including reward responsivity and smoking related behaviors.
Procedure:
Prior to coming to a screening visit, all potential participants will undergo a phone pre-screening using an IRB approved phone script to pre-identify potentially eligible participants and to potentially decrease screen fail rate. These interested potential participants call or email the site in response to advertisements. The pre-screening will take place via phone. Participants who pass the pre-screening will complete some or all of the following visits: Screening, Camera Return Visit, Real-Time Neurofeedback Visit, Follow-up Phone Call/Debriefing.
Screening Visit:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years of age
- •Right handed
- •In good general health
- •Male or Female
- •For ND individuals: Self-reported smoking ≥ 5 combustible cigarettes per day
- •For ND individuals: Afternoon expired CO concentration of ≥ 8 ppm
- •For ND individuals: Is willing and able to abstain from smoking for a few hours
排除标准
- •History of chronic/significant medical condition
- •Current or past 6 month use of prescription medications for psychiatric conditions (e.g., depression, anxiety)
- •Current or past 6 month diagnosis of anxiety, bipolar disorder, depression, OCD, schizophrenia, psychosis, or personality disorder.
- •Current substance abuse or dependence or history within the last 6 months (other than nicotine for ND individuals)
- •For ND individuals: Positive drug test for anything other than marijuana
- •For ND individuals: Currently on nicotine replacement therapy
- •For ND individuals: Individuals who role their own cigarettes
- •For ND individuals: Daily cannabis use
- •For ND individuals: Consume more than 21 alcoholic drinks per week
- •For ND individuals: Use harder drugs (e.g., cocaine, methamphetamine) more than 10 times per year
- •For ND individuals: Currently taking medication that directly acts on the dopamine system (e.g., L-DOPA).
- •Inability to understand written and/or spoken English language
- •For MRI subjects: Claustrophobia or other contraindications to MRI scanning
- •For MRI subjects: If female, pregnancy as determined by urine pregnancy test on the day of MRI scanning
- •For MRI subjects: Presence of any metal in the body (e.g., implant, non-removable piercing, metal IUD)
- •For MRI subjects: Head injury resulting in loss of consciousness
- •For MRI subjects: Worked with metal (e.g., welding) or had an injury to the eye involving metal
- •For MRI subjects: Weigh more than 250 pounds
结局指标
主要结局
Percent Change in Reward-related Brain Activation as Measured by fMRI
时间窗: Changes will be assessed across the task (~30 minutes) during the neurofeedback visit
The investigators will examine the change in brain activation in the target region (e.g., VTA) during the task. This includes prior to, during, and following real-time neurofeedback. Reported is the percent signal change from baseline (last 3 volumes of prior count condition).
Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power
时间窗: Baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback
The investigators will examine the change in brain activation in the target region (e.g., VTA) during the task. This includes prior to, during, and following real-time neurofeedback. Reported here is the change from baseline (prior to real-time neurofeedback) and \~30 minutes following real-time neurofeedback. The ratio of Beta to Theta power indicates the level of active brainwave activity (Beta) versus the level of resting brainwave activity (Theta).
次要结局
- Dopamine Availability(Collected once during the screening visit)
- Onset to Smoking a Cigarette(up to 30 minutes following the neurofeedback session)