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Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hot-Humid | Experimental | Participants will complete the trial in environmental conditions 38 degrees Celsius with 40% humidity. |
|
| Hot-Dry | Experimental | Participants will complete the trial in environmental conditions 41 degrees Celsius with 15% humidity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| End Skin Temperature | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin | Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administration |
| End Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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3 participants who signed the consent were withdrawn from the study prior to visit 1 due to either elevated bp at screening visit or they started a new medication that disqualified them from participating in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hot-Humid: Cocaine First Then Lidocaine | Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| FG001 | Hot-Humid: Lidocaine First Then Cocaine | Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| FG002 | Hot-Dry: Cocaine First Then Lidocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| FG003 | Hot-Dry: Lidocaine First Then Cocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hot-Humid: Cocaine First Then Lidocaine | Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Core Temperature | Core temperature will be measured either from a temperature sensor pill or from a rectal temperature probe. | Posted | Mean | Standard Deviation | Celsius | Core temperature is measured at baseline and at 60 minutes of heat exposure. |
|
Adverse data was collected through study completion, an average of one month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hot-Humid: Cocaine | Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Crandall | University of Texas at Southwestern | 214-345-4623 | craigcrandall@texashealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2024 | May 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| ID | Term |
|---|---|
| D003042 | Cocaine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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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.
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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.
| 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. |
|
Heart rate will be measured from ECG electrodes attached to the participant
| Measured at the end of heat exposure, 90 minutes from Cocaine/ lidocaine administration |
| Whole Body Sweat Rate | Whole body sweat rate is calculated by subtracting the participants post-heat exposure nude body weight from their pre-heat exposure nude body weight | 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 | Systolic and diastolic blood pressure will be measured from a cuff placed on the upper arm. | Measured at the end of heat exposure, 90 minutes from cocaine/ lidocaine administration |
| End Thermal Sensation | 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 | These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration) |
| BG001 | Hot-Humid: Lidocaine First Then Cocaine | Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| BG002 | Hot-Dry: Cocaine First Then Lidocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| BG003 | Hot-Dry: Lidocaine First Then Cocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Lidocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| OG002 | Hot-Dry: Cocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
| OG003 | Hot-Dry: Lidocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. |
|
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| Secondary | End Skin Temperature | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin | Posted | Mean | Standard Deviation | Celsius | Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administration |
|
|
|
| Secondary | End Heart Rate | Heart rate will be measured from ECG electrodes attached to the participant | Posted | Mean | Standard Deviation | BPM | Measured at the end of heat exposure, 90 minutes from Cocaine/ lidocaine administration |
|
|
|
| Secondary | Whole Body Sweat Rate | Whole body sweat rate is calculated by subtracting the participants post-heat exposure nude body weight from their pre-heat exposure nude body weight | Posted | Mean | Standard Deviation | L/hour | 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) |
|
|
|
| Secondary | End Mean Arterial Pressure | Systolic and diastolic blood pressure will be measured from a cuff placed on the upper arm. | Posted | Mean | Standard Deviation | mmHg | Measured at the end of heat exposure, 90 minutes from cocaine/ lidocaine administration |
|
|
|
| Secondary | End Thermal Sensation | 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 | Posted | Mean | Standard Deviation | units on a scale | These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Hot-Humid: Lidocaine | Participants will complete two trials in environmental conditions 38 degrees Celsius with 40% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Hot-Dry: Cocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Hot-Dry: Lidocaine | Participants will complete 2 trials in environmental conditions 41 degrees Celsius with 15% humidity. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 1. Cocaine or lidocaine (randomized) will be administered intranasally prior to entering the warm environmental conditions and performing 60 minutes of exercise on visit 2. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014947 | Wounds and Injuries |
| D001519 | Behavior |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |