NCT03266939撤回1 期
Rebalancing the Serotonergic System in Cocaine Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.
研究概览
简要总结
In the United States, 1.5 million people abuse cocaine leading to a host of negative health and economic consequences, yet no FDA approved treatment exists. To develop effective treatments, the following must be considered: 1) do potential medications ameliorate brain disruptions associated with cocaine use? 2) are multiple, targeted treatments necessary? To meet these goals, innovative multi-modal neuroimaging will be used to determine whether rebalancing the serotonergic (5-HT) system reduces cocaine cue reactivity, impulsivity, and normalizes related neurochemistry and brain connectivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •- Participants will be male and female volunteers between the ages of 18-55
- •Participants will report having used cocaine on at least four occasions within the month prior to screening; the urine sample obtained during the screening visit must be positive for the cocaine metabolite benzoylecgonine (>300 ng/ml). They can meet DSM-IV criteria for cocaine abuse and dependence.
- •Participants cannot meet DSM-IV criteria for current psychotic disorders (e.g., bipolar disorder, schizophrenia, schizoaffective disorder)
- •Participants cannot meet DSM-IV criteria for a current major depressive episode
- •Participants cannot meet DSM-IV criteria for current drug dependence (except nicotine, cocaine, and marihuana)
- •Participants must test negative for alcohol use on the day of the scan.
- •Participants can report current abuse of marihuana and tobacco. Participants cannot have used marihuana within twelve hours of their study visits.
- •Participants cannot be regular opiate users including prescription opiate analgesics
- •Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
- •Participants cannot have any conditions that are contraindicated for MRI (see next section)
- •Participants cannot be pregnant (pregnancy test will be performed before each scanning session)
- •Participants must be able to read screening materials including consent form and give informed consent
- •Participants cannot be taking any medications with a 5-HT mechanism including serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs) and St. John's Wort and tryptophan.
- •Participants cannot be currently taking any medications that might affect the central nervous system including prescription analgesics, anxiolytics, antipsychotics, and antidepressants. A complete review of medications will be evaluated by study staff.
- •Cannot have any history of a medical condition that might affect the central nervous system at the time of scanning including: Abnormal structural MRI, or a history of head trauma or injury causing loss of consciousness lasting longer than 3 minutes or associated with skull fracture or intracranial bleeding or who had irremovable magnetically active objects on or within their body, or history of epilepsy.
排除标准
- •- Weight greater than 350 pounds (cannot easily fit inside the magnet bore)
- •Cardiac pacemakers
- •Aneurysm clips and other vascular stents, filters, clips or other devices
- •Prosthetic heart valves
- •Other prostheses
- •Neuro-stimulator devices
- •Implanted infusion pumps
- •Cochlear implants
- •Ocular implants or known metal fragments in eyes
- •Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
- •Other metallic surgical hardware in vital areas
- •History of major head trauma resulting in cognitive impairment
- •Certain tattoos (e.g. older dye with metallic pigment)
- •Certain medication patches (if they cannot be removed)
- •Metal containing IUDs
- •Claustrophobia
- •Pregnancy
- •Metallic implants except fillings and crowns
- •Tattoos containing metallic ink on the neck, shoulders, upper arm, and head (these could become heated during scanning, potentially causing burns
- •Medication patches that cannot be removed during scanning
- •Claustrophobia
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo Oral Tablet (Drug)
Active Medication
Active Comparator
干预措施: Lorcaserin (Drug)
结局指标
主要结局
Influence of lorcaserin on fMRI measured brain-reactivity to drug cues.
时间窗: fMRI measures will be gathered on scanning visits 1 and 2 (approx 1 week apart)
次要结局
未报告次要终点
研究者
Amy C. Janes
Principal Investigator
Mclean Hospital
研究点 (1)
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