University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
NCT Number: NCT05809453
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Phase 1 / Phase 2
Dallas, Texas, 75390, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cocaine (cocaine hydrochloride 4% nasal solution) will be administered (3 mg/kg) intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise.
Lidocaine (lidocaine hydrochloride 4% nasal solution) will be administered (3 mg/kg) intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise.
Time frame: 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.
Time frame: Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administration
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin
Time frame: Measured at the end of heat exposure, 90 minutes from Cocaine/ lidocaine administration
Heart rate will be measured from ECG electrodes attached to the participant
Time frame: 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)
Whole body sweat rate is calculated by subtracting the participants post-heat exposure nude body weight from their pre-heat exposure nude body weight
Time frame: Measured at the end of heat exposure, 90 minutes from cocaine/ lidocaine administration
Systolic and diastolic blood pressure will be measured from a cuff placed on the upper arm.
Time frame: These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration)
Subjective assessment of how hot the subject feels.
Title of Scale: Thermal Sensation Scale; Minimum value: -50 "unbearably cold"; Maximum value: 50: "unbearably hot" Scale presents numbers in increments of 5
University of Texas Southwestern Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06630832
Behavior, Behavioral Symptoms
Ottawa, Ontario, Canada
View Trial DetailsNCT07433036
Behavior, Body Temperature Changes
Colorado Springs, Colorado, United States
View Trial DetailsNCT06670365
Aging, Body Temperature Changes
Ottawa, Ontario, Canada
View Trial DetailsNCT06998667
Body Temperature Changes, Heat Acclimation and Thermotolerance
Palo Alto, California, United States
View Trial Details