Intranasal Cocaine and Temperature Regulation During Exercise

Exercise Clinical Trial

Official title:

Intranasal Cocaine and Temperature Regulation During Exercise

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05809453
• Other study ID #: STU-2023-0094
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cocaine Use
• Exercise
• Hyperthermia

Intervention

Drug:
• Cocaine
Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise.
• Lidocaine
Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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