Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine whether varenicline, as compared to placebo, can blunt the limbic activation (e.g., amygdala, ventral striatum/ventral pallidum, etc.) by ultra-brief cocaine cues using fast event-related fMRI.
研究概览
简要总结
Our proposal will enable us to study cocaine patients to determine whether varenicline can weaken brain arousal to drug cues in an fMRI imaging setting, which is what we theorize. This supplement supports a pilot imaging study in cocaine dependence. It will evaluate the impact of varenicline on the brain response to ultra-brief drug and comparison cues in an event-related fMRI paradigm. This is a pilot study.
We will additionally examine the impact of varenicline on addiction-relevant behavioral probes of impulsivity, inhibition, attentional and affective bias. The proposed study will provide the first brain-behavioral probes of varenicline's cocaine-relevant actions in humans, and will provide the critical scientific rationale to move the agent into future collaborative clinical trials.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Physically healthy male substance abuse subjects age 18-55.
排除标准
- •Participation in clinical trial and receipt of investigational drug(s) during previous 60 days 2) Clinically significant cardiovascular, hematologic, hepatic, renal, neurological or endocrinological abnormalities 3) History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes. 4) Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in subject's body (unless a radiologist confirms that its presence is unproblematic). A x-ray may be obtained to determine eligibility. 5) Claustrophobia or other medical condition disabling subject from lying in the MRI for approximately 60 minute
研究组 & 干预措施
chantix
干预措施: chantix (Drug)
结局指标
主要结局
To determine whether varenicline, as compared to placebo, can blunt the limbic activation (e.g., amygdala, ventral striatum/ventral pallidum, etc.) by ultra-brief cocaine cues using fast event-related fMRI.
时间窗: End of study
次要结局
- Varenicline (vs. placebo) may reduce positive affective bias to drug (cocaine) cues.(End of study)