Oxytocin in Cocaine Dependence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Subjective Stress Response TSST
研究概览
简要总结
Stress is likely involved in relapse to cocaine use. This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.
详细描述
Stress is an important predictor of relapse, and targeting stress-activated pathways may lead to therapeutic advancements in the treatment of substance use disorders. Oxytocin has been shown to promote trust, social bonding, and calmness; however, its potential effects have not been explored in cocaine-dependent individuals. Oxytocin receptors have been localized to brain regions that are activated by drug-paired cues and preclinical studies have shown that oxytocin attenuates the acute and long-term behavioral effects of psychostimulants. However, little is known about the role of oxytocin in mediating the affective response to cocaine-paired cues and associated neural activity in cocaine-dependent men and women. This project is a direct evolution from our previous SCOR-supported research. Our work has progressed from characterizing sex/gender differences in response to social stressors and cocaine cues in cocaine-dependent men and women, to our on-going work evaluating whether stress potentiates cue-induced craving and the impact of hormones on this response. The proposed study will investigate the role of oxytocin in the sex/gender differences in stress response and craving in cocaine-dependent individuals and preliminarily explore its therapeutic potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TSST Men Placebo
Cocaine-dependent men received intranasal saline prior to completing a Social Stress Task.
干预措施: Saline (Drug)
TSST Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
干预措施: Oxytocin (Drug)
TSST Women Placebo
Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.
干预措施: Saline (Drug)
MRI 1 Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
干预措施: Oxytocin (Drug)
MRI 1 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
干预措施: Saline (Drug)
MRI 2 Women Oxytocin
Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
干预措施: Oxytocin (Drug)
MRI 2 Women Placebo
Cocaine-dependent women received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
干预措施: Saline (Drug)
TSST Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.
干预措施: Oxytocin (Drug)
MRI I Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.
干预措施: Oxytocin (Drug)
MRI I Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the first of two fMRI cue-exposure tasks.
干预措施: Saline (Drug)
MRI 2 Men Oxytocin
Cocaine-dependent men received 40 IUs of intranasal oxytocin prior to completing the second of two fMRI cue-exposure tasks.
干预措施: Oxytocin (Drug)
MRI 2 Men Placebo
Cocaine-dependent men received intranasal saline prior to completing the second of two fMRI cue-exposure tasks.
干预措施: Saline (Drug)
结局指标
主要结局
Subjective Stress Response TSST
时间窗: Subjects rated stress immediately following a Social Stress task on Day 1 of 3.
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
Subjective Stress Response MRI 1
时间窗: Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels
Subjective Stress Response MRI 2
时间窗: Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.
Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.
次要结局
- Subject Cocaine Craving MRI 2(Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.)
- Subject Cocaine Craving TSST(Subjects rated craving immediately following a Social Stress task on Day 1 of 3.)
- Subject Cocaine Craving MRI 1(Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.)
研究者
Aimee McRae-Clark
Associate Professor of Psychiatry
Medical University of South Carolina