Intranasal Cocaine and Temperature Regulation During Exercise
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in Core Temperature
研究概览
简要总结
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
详细描述
Previously it was shown that intranasal cocaine attenuates skin blood flow and sweating responses during passive heat stress, when compared to placebo. However, nothing is known about the effects of cocaine on whole-body temperature regulation during mild to moderate exercise in warm environmental condition.
This project will test the hypothesis that intranasal cocaine attenuates whole-body sweat rate, resulting in greater elevations in core temperature during mild to moderate exercise in warm environmental conditions.
Primary data include core temperature, skin temperatures, and whole body sweat rate. Secondary variables include cardiovascular responses, perceptions of exercise exertion and thermal comfort, and metabolic heat production. Intranasal lidocaine will be used as the placebo for cocaine. The selection of the drug administered during the first experimental trial will be randomized, with the other drug administered during the second experimental trial.
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 (Investigator)
盲法说明
Our research nurse will know whether the participant will receive cocaine or lidocaine. All others involved in the protocol, including the participant, will not know which agent they received for which trial.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years of age
- •Body mass index less than 31 kg/m^2
- •Speak English
- •Systolic blood pressure <140 mmHg
- •Diastolic blood pressure <90 mmHg
排除标准
- •Subjects not in the defined age range
- •Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
- •Any known history of renal or hepatic insufficiency/disease
- •Pregnancy or breast feeding
- •Body mass less than 60 kilograms
- •Current smokers, as well as individuals who regularly smoked within the past 3 years
- •Individuals with a history of drug abuse within the past 5 years
- •Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results and when agent abstained the drug screen is negative, one example could be an over the counter supplement)
- •Currently taking pain modifying medications
研究组 & 干预措施
Hot-Humid
Participants will complete the trial in environmental conditions 38 degrees Celsius with 40% humidity.
干预措施: Cocaine (Drug)
Hot-Humid
Participants will complete the trial in environmental conditions 38 degrees Celsius with 40% humidity.
干预措施: Lidocaine (Drug)
Hot-Dry
Participants will complete the trial in environmental conditions 41 degrees Celsius with 15% humidity.
干预措施: Cocaine (Drug)
Hot-Dry
Participants will complete the trial in environmental conditions 41 degrees Celsius with 15% humidity.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Change in Core Temperature
时间窗: Core temperature is measured at baseline and at 60 minutes of heat exposure.
Core temperature will be measured either from a temperature sensor pill or from a rectal temperature probe.
次要结局
- End Skin Temperature(Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administration)
- End Heart Rate(Measured at the end of heat exposure, 90 minutes from Cocaine/ lidocaine administration)
- Whole Body Sweat Rate(Within 30 minutes before exposure to warm environmental conditions (before cocaine/ lidocaine administration) and immediately after the heat exposure (90 minutes post cocaine/ lidocaine administration))
- End Mean Arterial Pressure(Measured at the end of heat exposure, 90 minutes from cocaine/ lidocaine administration)
- End Thermal Sensation(These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration))
研究者
Craig Crandall
Professor of Internal Medicine
University of Texas Southwestern Medical Center