Effect of Nicotine on Brain Reward Pathways
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from Placebo in functional magnetic resonance imaging (fMRI) BOLD Response
研究概览
简要总结
The investigators will determine whether an acute dose of nicotine, in the form of the nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in individuals with major depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- •Subjects with suicidal ideation where outpatient treatment is determined unsafe. These patients will be immediately referred to a licensed psychologist or psychiatrist to determine the appropriate clinical treatment;
- •Serious or unstable medical illness
- •Lifetime history of seizure disorder;
- •Lifetime history or current diagnosis of any of the following DSM-IV psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, ADHD, patients with mood congruent or mood incongruent psychotic features; simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to MDD;
- •Patients with a lifetime history of electroconvulsive therapy (ECT);
- •Failure to meet standard MRI safety requirements;
- •May not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine
- •Must have an expired carbon monoxide level of less than or equal to 10 ppm.
- •Use of anticholinergic drugs in the past week
- •Any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease
- •Uncontrolled hypertension
- •History of substance abuse in the past 6 months (other than caffeine), self-reported use of marijuana in past month, or history of treatment with methadone
- •Heavy caffeine users (consume greater than 500 mg on a regular or daily basis)
- •Subjects that cannot speak English
研究组 & 干预措施
Nicotine
2mg of nicotine in the form of a nicotine polacrilex lozenge will be administered orally, one time.
4mg of nicotine in the form of a nicotine polacrilex lozenge will be administered orally, one time.
干预措施: Nicotine polacrilex (Drug)
Placebo
Placebo comparator
干预措施: Nicotine polacrilex (Drug)
结局指标
主要结局
Change from Placebo in functional magnetic resonance imaging (fMRI) BOLD Response
时间窗: Participants will be assessed during 2 fMRI scanning sessions, an expected average of 2 weeks.
Nicotine will enhance the fMRI BOLD response to monetary reinforcers relative to placebo administration
次要结局
未报告次要终点
研究者
Amy C. Janes
Assistant Professor/Neuroscientist
Mclean Hospital