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Completed

NCT Number: NCT05809453

Intranasal Cocaine and Temperature Regulation During Exercise

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocaine

Drug

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

Drug

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.

Primary outcomes

  1. Change in Core Temperature

    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.

Secondary outcomes

  1. End Skin Temperature

    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

  2. End Heart Rate

    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

  3. Whole Body Sweat Rate

    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

  4. End Mean Arterial Pressure

    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.

  5. End Thermal Sensation

    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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2023
Registry last updated
Jul 14, 2025

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.

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