Intranasal Cocaine and Temperature Regulation During Exercise

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cocaine Use

Hyperthermia

Exercise

Treatments

Drug: Lidocaine

Drug: Cocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05809453

STU-2023-0094

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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