Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group
研究概览
简要总结
The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.
详细描述
Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of prosocial effects in humans including enhancing trust and generosity, improving positive communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks. With this study, the investigators will characterize oxytocin's effects on the neural processing of salient stimuli. The investigators will utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI), to assess brain activity while participants perform tests designed to engage neural circuits associated with the processing of social and non-social stimuli.
Ongoing clinical trials are examining the use of intranasal oxytocin for the treatment of multiple psychiatric disorders including substance dependence, depression, and schizophrenia; disorders which reward system dysfunction appears to play a significant role. As such, it is important that we obtain a better understanding of the neurobiological effects this drug may have on reward circuitry functioning. To this end, in this study, we will examine healthy control participants and participants diagnosed with Alcohol Use Disorder (AUD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •18-45 years of age at the time of screening
排除标准
- •Participants unable to tolerate the scanning procedures or would be unfit for scanning purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of the scan)
- •Psychiatric Illness Criteria:
- •Controls: No current or past history of psychiatric illness, including substance use disorder (except nicotine)
- •AUD: No history of, or current, psychotic disorder, antisocial personality disorder, or bipolar disorder, or concurrent post-traumatic stress disorder. Must meet DSM-5 criteria for current moderate-to-severe AUD, abstinent from alcohol for 2-8 weeks prior to study enrollment, express a desire to achieve abstinence or to greatly reduce alcohol consumption
- •Illicit Drug Use
- •Control: Any reported current (within the last 2 months) use of any category of illicit drugs
- •Patients: Dependence (moderate to severe) to any other substance within the last 2 months other than alcohol or nicotine
- •Any current or past history of any serious medical or neurological illness
- •Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction, hyponatremia, traumatic brain injury, atrophic rhinitis, recurrent nose bleeds, and cranial-surgical procedures (hypophysectomy).
- •Abnormal MRI (except if due to technical factors)
- •Female subjects who are pregnant, trying to become pregnant, or nursing
- •Known allergies to oxytocin or to preservatives in the nasal spray
- •Participants reporting use of an intranasal medication in the past two weeks
- •Participants taking medications including any current treatment with antipsychotics, antidepressants, mood stabilizers, psychostimulants and psychostimulant appetite suppressants, or past treatment with isoniazid, glucocorticoids, centrally active antihypertensive drugs (e.g., clonidine, reserpine), or sedative hypnotic medications (e.g. benzodiazepines, barbiturates, within 1 week prior to study enrollment). Treatment within six months with any of the following: hormone use (i.e. testosterone, DHEA), opioid drugs.
- •Unable to comply with study procedures or protocols
研究组 & 干预措施
Placebo
Each participant will be studied using fMRI following self-administration of placebo.
干预措施: Placebo (Drug)
Oxytocin
Each participant will be studied using fMRI following self-administration of oxytocin.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group
时间窗: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group
时间窗: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls
时间窗: Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1)
次要结局
未报告次要终点
研究者
Brian Mickey
MD, Ph.D.
University of Utah