Dopamine Rhythms in Health and Addiction
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls.
研究概览
简要总结
Background:
- Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day.
Objectives:
- To look for changes to a person s biological clock in the function of the dopamine reward system. To test if cocaine disrupts this.
Eligibility:
- Adults age 21-55 with a cocaine use disorder.
- Healthy volunteers age 21-55.
Design:
- Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking.
- Participants will have 3 overnight clinic visits.
- Visit 1: They will have blood and urine collected and a heart test.
- A plastic tube (catheter) will be placed into a vein in each arm by needle.
- Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug (blocks dopamine removal) will be injected via catheter. Vital signs will be measured and blood will be drawn throughout.
- Visit 2: repeats Visit 1, except at night.
- Visit 3, participants will have urine collected.
- They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will lie on a table that slides in and out of it, with a coil over their head.
- Participants may answer questions, take computer or paper tests, and perform simple actions.
- For 1 week, participants will wear a wrist device that measures daily activity.
详细描述
Objectives:
The primary objective is to assess if there is disruption of circadian DA rhythms in cocaine addiction. The secondary objective is to assess if dopamine modulates the sensitivity of the brain reward network in a circadian dependent manner.
Study Population:
Non-treatment seeking cocaine abusers (moderate or severe cocaine use disorder as per DSM-IV or DSM 5) and healthy controls. Males and females will be included.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（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
Evening MRI/PET/Raclopride/IV Methylphenidate Session
The PET [11C] raclopride scan will be done between 5-7 PM. After iv catheters are inserted blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plus-infusion method for [11C]raclopride and the administration of intravenous MP (0.5 mg/kg) forty-five minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes.
干预措施: Brain Dopamine Reactivity (Drug)
Evening MRI/PET/Raclopride/IV Methylphenidate Session
The PET [11C] raclopride scan will be done between 5-7 PM. After iv catheters are inserted blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plus-infusion method for [11C]raclopride and the administration of intravenous MP (0.5 mg/kg) forty-five minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes.
干预措施: Brain Dopamine Receptor (Radiation)
Morning MRI/PET/Raclopride/IV Methylphenidate Session
Morning Session [11C]raclopride PET scan: To be started between 7-8 AM. After iv catheters are inserted, genetic blood samples are drawn and then blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plusinfusion method for [11C]raclopride and the administration of intravenous MP (0.25 mg/kg) fortyfive minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes.
干预措施: Brain Dopamine Reactivity (Drug)
Morning MRI/PET/Raclopride/IV Methylphenidate Session
Morning Session [11C]raclopride PET scan: To be started between 7-8 AM. After iv catheters are inserted, genetic blood samples are drawn and then blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plusinfusion method for [11C]raclopride and the administration of intravenous MP (0.25 mg/kg) fortyfive minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes.
干预措施: Brain Dopamine Receptor (Radiation)
结局指标
主要结局
To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls.
时间窗: end of study
To assess if there are diurnal rhythms in DA signaling and in reward brain circuits and to determine if these are disrupted in cocaine addiction.
次要结局
- Measuring dopamine signaling(end of study)
- Measuring circadian typology(end of study)
- Measuring sleep patterns(end of study)