跳至主要内容
临床试验/NCT03213418
NCT03213418终止不适用

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
1
主要终点
Abstinence

研究概览

简要总结

This project aims to develop electroretinogram as a new putative marker for dopamine release, and as a predictor of treatment response among patients seeking treatment for smoking cessation. Tobacco smoking continues to be a major public health challenge. Dopamine is a neurotransmitter released in the brain. Several lines of evidence suggest that dopamine release deficit in the brain is involved in the development and maintenance of nicotine dependence. The investigators hypothesize that smokers who do not have a deficit in dopamine release will more readily respond to behavioral treatment for smoking cessation, and in particular, financial incentives contingent on abstinence (Contingency Management). Previous pilot data suggest electroretinogram (ERG), which records electrical signals from the retina in response to light, is a clinically accessible correlate to dopamine release in the brain. The project proposes an ERG-based biomarker, and a pilot clinical trial to apply this biomarker to personalize smoking cessation treatment. This clinically tractable biomarker of central dopamine release may have a large number of future applications in the diagnosis and treatment of other mental illnesses and substance use disorders.

The study will recruit normal controls and smokers, measure ERG before and after a standard dose of oral immediate release methylphenidate. Smokers will undergo a 12-week standardized treatment course of CM. The investigators will test whether smoking status and the response to CM are correlated to changes in ERG in response to methylphenidate challenge.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Abstinence

时间窗: 1 month

Prolonged abstinence from cigarette smoking will be measured through a combination of self-reported timeline follow back, as it is corroborated with urine cotinine and expired CO levels.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Luo

Research Psychiatrist

New York State Psychiatric Institute

研究点 (1)

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