Exercise Clinical Trial
Official title:
Intranasal Cocaine and Temperature Regulation During Exercise
Verified date | May 2024 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 18 to 50 years of age - Healthy - Body mass index less than 31 kg/m^2 - Speak English - Systolic blood pressure <140 mmHg - Diastolic blood pressure <90 mmHg Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in core body temperature | Core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer | Within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period. | |
Secondary | Change in skin temperature | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin | Within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period. | |
Secondary | Change in heart rate | Heart rate will be measured from ECG electrodes attached to the participant | Within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period. | |
Secondary | Change in whole body sweat rate | Whole body sweat rate will be measured by nude weight of the participant | Within 30 minutes before exposure to warm environmental conditions and immediately after the 30 minute recovery period. | |
Secondary | Change in blood pressure | Systolic and diastolic blood pressure will be measured from a cuff placed on the upper arm. | Within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period. | |
Secondary | Perceptual questionnaire on how hot one feels | Subjective assessment of how hot the subject feels.
Title of Scale: Thermal Sensation Scale; Minimum value: 0 "unbearably cold"; Maximum value: 8: "unbearably hot" |
These values will be obtained throughout the 60 minutes of exercise and during the 30 minute recovery period | |
Secondary | Perceptual questionnaire on how hard one feels they are exercising | Subjective assessment of how hard the subject feels they are exercising
Title of scale: Rating of Perceived Exertion Borg Scale; Minimum value: 6 "No exertion at all"; Maximum value: 20 "Maximum exertion" |
These values will be obtained throughout the 60 minutes of exercise and during the 30 minute recovery period |
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