Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Average change in Luteinizing Hormone (LH) pulse frequency
研究概览
简要总结
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.
详细描述
Arm 1 Assignment: Individuals will be assigned to group 1 or group 2 based on their genetic features.
Arm 2 Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
-
Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
-
During the study, the subjects will complete the following
-
Arm 1: Undergo frequent blood sampling for up to 12 hours
-
Arm 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years (women) OR 18-60 years (men)
- •Genetic sequencing data available via Mass General Brigham Biobank
- •All medical conditions stable and well controlled
- •If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
- •Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
- •Negative urine drug screening panel
- •Hemoglobin within sex-specific reference range
- •For women, negative serum hCG pregnancy test
- •Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
- •Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
- •Current or recent use of a medication that affects the opioid pathway
- •Active illicit drug use
- •Excessive alcohol consumption (> 10 drinks/week)
- •For women, pregnant or breastfeeding
排除标准
- 未提供
研究组 & 干预措施
Arm 2
one period of frequent blood sampling with no medication administered; one period of frequent blood sampling with IV administration of naloxone (one bolus and an infusion over an up to 12-hour period.)
干预措施: Naloxone (Drug)
Arm 1
one period of frequent blood sampling with no medication administered
结局指标
主要结局
Average change in Luteinizing Hormone (LH) pulse frequency
时间窗: Two 12-hour periods
Change in LH pulse frequency before and during naloxone infusion
Difference in Average LH Pulse Frequency
时间窗: one 12-hour period
difference in LH pulse frequency between variant-carriers and control participants
次要结局
- Average change in LH pulse amplitude(Two 12-hour periods)
研究者
Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Massachusetts General Hospital