Concurrent PET D2/D3 Receptor Imaging and fMRI Smoking Cue Reactivity in Smokers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Dopamine D3 Receptor Binding Potential Difference Between Smokers and Nonsmokers
研究概览
简要总结
This trial aims to determine whether dopamine D3 receptors are elevated in smokers versus nonsmokers and whether correlations exist between D3 receptor binding potential (BP) and functional MRI (fMRI) reactivity to smoking cues, which has been associated with smoking relapse vulnerability.
Neuroimaging measures of D3 BP and smoking cue fMRI reactivity will be collected concurrently in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers using a 3 Tesla MRI scanner configured to conduct fMRI and Positron Emission Tomography (PET).
We will measure D3 receptor BP using radiolabeled [11C]-(+)-PHNO, which has a relatively higher affinity for D3 versus D2 receptors.
We hypothesize that D3 BP will be elevated in smokers versus nonsmokers and that in smokers, there will be a positive correlation between smoking cue fMRI reactivity and D3 BP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •competent to provide written informed consent
- •Smokers: self-report of smoking 15 or more cigarettes/day for the past year, self-report of smoking first cigarette of the day within 30 minutes of awakening, meets DSM-IV criteria for Nicotine Dependence, provides expired breath carbon monoxide reading of > 10 ppm at enrollment
- •Nonsmokers: self-report of consuming <100 cigarettes in their lifetime, none in the last 6 months, provides expired breath carbon monoxide reading of < 9 ppm at enrollment
- •Women of childbearing potential: negative STAT serum beta-human chorionic gonadotrophin pregnancy test before scanning
排除标准
- •pregnant or able to become pregnant and not willing to undergo blood pregnancy test
- •unstable medical illness with likely hospitalization for treatment within 6 months
- •life-threatening arrhythmia, cerebro-vascular or cardiovascular event within 6 months of enrollment; liver function tests elevated over 2.5x normal; CNS tumor or seizure disorder
- •users of other tobacco- or nicotine-containing products (gum, patches, e-cigarettes)
- •lifetime history of DSM-IV bulimia, organic mental disorder, brain injury or psychotic disorder
- •6 month history of non-nicotine substance use disorder or major depression
- •history of multiple adverse drug reactions
- •current use of excluded concomitant medications (smoking cessation medications)
- •known history of allergic reaction to the PET ligand [11C]-PHNO, its components, or any medication
结局指标
主要结局
Dopamine D3 Receptor Binding Potential Difference Between Smokers and Nonsmokers
时间窗: March 2014
We will determine whether dopamine D3 receptor binding potential, a dimensionless number which represents the relative concentration of dopamine D3 receptors available for binding, is elevated in smokers versus nonsmoking controls.
次要结局
- Smoking Cue fMRI Reactivity Association with Dopamine D3 Receptor Binding Potential(March 2014)
研究者
Marc J. Kaufman
Director, Translational Imaging Laboratory, McLean Hospital
Mclean Hospital