2024-517598-26-00招募中2 期
Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers
Linkopings Universitet1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年10月21日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The dependent variable will be the total number of spins the participant carries out in the Slot Machine task.
研究概览
简要总结
Study 1: The primary objective of this protocol is to investigate whether IV ghrelin will alter decision making processes including those that involve a) evaluation of reward; b) propensity to take on risk; c) trading off of small immediate rewards vs larger, temporally more distant ditto (delay discounting), and d) goal-directed learning; as well as the neural substrates associated with these decision making processes, measured using fMRI.
Study 2: The primary objective of the protocol is to investigate whether IV ghrelin will affect sensitivity to losses in a gambling environment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years.
- •Good health as determined by medical history, ECG and clinical assessment of lab tests. Lab tests will include sodium, potassium, creatinine, hemoglobin, EVF, erythrocytes, leukocytes, platelets, MCV, MCH, MCHC, albumin, bilirubin, plasma lipids, ALP, ASAT, ALAT, CRP, GT. The final decision will be according to the judgment of the investigator.
- •Creatinine ≤ 176 µmol/L.
- •Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
- •Participant must be willing to receive two IV lines.
- •Inclusion criteria specific for study 1 Participant must be willing to undergo an MR scan.
- •nclusion criteria specific for study 2 Proficiency in Swedish.
排除标准
- •Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- •Specific exclusion criteria related to the administration of ghrelin are chronic inflammatory diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease), diabetes, obesity (BMI ≥ 30 kg/m2), weight ≥ 120 kg, high triglycerides level (> 4,0 mmol/l), history of clinically significant hypotension (e.g., history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.
- •Any use of CNS-active medications.
- •Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
- •Pregnancy, intention to become pregnant, or breastfeeding a child.
- •Exclusion criteria specific for study 1 Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine; any history of a past eating disorder, psychotic illness, or bipolar disorder; as determined by medical history, and MINI interview carried out by appropriately trained staff.
- •Exclusion criteria specific for study 1 Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
- •Exclusion criteria specific for study 2 Any current clinically significant psychiatric problems including a DSM-5 diagnosis of severe Substance Use Disorder other than nicotine, or Gambling Disorder. Patients will be screened using the Modified MINI Screen [MMS], the Alcohol Use Disorder Identification Test [AUDIT], the Drug Use Disorder Identification Test (DUDIT] and the NORC Diagnostic Screen for Gambling Problems [NODS]. The results and their clinical significance will be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If an indication is obtained that a clinically significant psychiatric disorder may be present, a full structured diagnostic interview [MINI] will be carried out by appropriately trained staff prior to determining eligibility.
- •Exclusion criteria specific for study 2 Any lifetime history of problematic gambling.
结局指标
主要结局
The dependent variable will be the total number of spins the participant carries out in the Slot Machine task.
The dependent variable will be the total number of spins the participant carries out in the Slot Machine task.
次要结局
- The dependent variable will be the proportion of trials in which the participant gambled, i.e.; chose the option with an uncertain over that with a certain outcome in the Gambling Task.
- The dependent variable will be the mean number of pumps per trial, excluding trials where the balloon explodes in the Balloon Analog Risk Task..
研究者
Markus Heilig
Scientific
Linkopings Universitet
研究点 (1)
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