Intranasal Cocaine and Temperature Regulation During Exercise

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-08-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hyperthermia Cocaine Use Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Hot-Humid

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

Group Type EXPERIMENTAL

Cocaine

Intervention Type 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

Intervention Type 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

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

Group Type EXPERIMENTAL

Cocaine

Intervention Type 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

Intervention Type 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.

Interventions

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Cocaine

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.

Intervention Type DRUG

Lidocaine

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes