Intranasal Cocaine and Temperature Regulation During Exercise

NCT05809453 | Completed Phase 1 Results FDA Drug

• 1 other identifier: STU-2023-0094
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperthermia; Cocaine Use; Exercise

Keywords

thermoregulation; sweating; skin blood flow

Outcome Measures

Primary Outcomes (1)

• Change in Core Temperature

  Core temperature will be measured either from a temperature sensor pill or from a rectal temperature probe.

  Core temperature is measured at baseline and at 60 minutes of heat exposure.

Secondary Outcomes (5)

• 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)

Study Arms (2)

Hot-Humid

EXPERIMENTAL

Participants will complete the trial in environmental conditions 38 degrees Celsius with 40% humidity.

Drug: Cocaine; Drug: Lidocaine

Hot-Dry

EXPERIMENTAL

Participants will complete the trial in environmental conditions 41 degrees Celsius with 15% humidity.

Drug: Cocaine; Drug: Lidocaine

Interventions

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.

Hot-Dry; Hot-Humid

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.

Hot-Dry; Hot-Humid

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hyperthermia; Motor Activity

Interventions

Cocaine; Lidocaine

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Craig Crandall
• Organization: University of Texas at Southwestern

craigcrandall@texashealth.org

214-345-4623

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: We will conduct a double-blind, placebo-controlled, crossover study. Following informed consent and screening, eligible participants will be randomized to complete the cocaine or the lidocaine (placebo) trial first, with the other "agent" administered during the subsequent visit. During these experimental visits, we will first obtain "pre-drug" temperature and cardiovascular data, which will be followed by administer of cocaine or lidocaine intranasally. Participants will then enter the chamber set to warm environmental conditions. After further instrumentation in the warm environment, participants will perform mild to moderate intensity physical activity for 60 minutes. Throughout the 60 minutes of physical activity we will record body temperature and cardiovascular responses. Upon concluding the physical activity, subjects will rest while body temperature and cardiovascular responses are obtained post-physical activity.

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 12, 2023
• Study Start: September 1, 2023
• Primary Completion: June 5, 2024
• Study Completion: August 1, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Locations

US (1)