HyperthermiaPhase 1/2NCT05809453
Intranasal Cocaine and Temperature Regulation During Exercise
A Phase 1/2 study testing Cocaine and Lidocaine in people with Hyperthermia and Cocaine Use, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Cocaine Use, Exercise
- What is being tested?
- Cocaine and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
Read the detailed 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.
- Conditions
- Hyperthermia, Cocaine Use, Exercise
- Being tested
- Cocaine, Lidocaine
- Keywords
- thermoregulation, sweating, skin blood flow
- Medical subject headings
- Hyperthermia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocaineDrug
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.
LidocaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hot-Humid | Experimental | Participants will complete the trial in environmental conditions 38 degrees Celsius with 40% humidity. Receives: Drug: Cocaine; Drug: Lidocaine |
| Hot-Dry | Experimental | Participants will complete the trial in environmental conditions 41 degrees Celsius with 15% humidity. Receives: Drug: Cocaine; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Core Temperature
Core temperature will be measured either from a temperature sensor pill or from a rectal temperature probe.
Measured: Core temperature is measured at baseline and at 60 minutes of heat exposure.
Secondary outcomes (5)
End Skin Temperature
Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin
Measured: Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administration
End Heart Rate
Heart rate will be measured from ECG electrodes attached to the participant
Measured: 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
Measured: 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: 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
Measured: These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Sep 2023
- Primary completion5 Jun 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809453
- Sponsor's protocol ID
- STU-2023-0094
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2023
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Cocaine and Temperature Regulation During Exercise
- ClinicalTrials.gov ID
- NCT05809453
- Acronym / sponsor ID
- STU-2023-0094
- Conditions
- Hyperthermia, Cocaine Use, Exercise
- Keywords
- thermoregulation, sweating, skin blood flow
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hot-Humid | Experimental | Drug: Cocaine, Drug: LidocaineParticipants will complete the trial in environmental conditions 38 degrees Celsius with 40% humidity. |
| Hot-Dry | Experimental | Drug: Cocaine, Drug: LidocaineParticipants will complete the trial in environmental conditions 41 degrees Celsius with 15% humidity. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 50 years of age
- Healthy
- Body mass index less than 31 kg/m^2
- Speak English
- Systolic blood pressure <140 mmHg
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CocaineCocaine (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. | Drug | Hot-Dry, Hot-Humid |
| LidocaineLidocaine (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. | Drug | Hot-Dry, Hot-Humid |
Primary outcome
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.
5 secondary outcomes
End Skin Temperature
Time frame: Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administration
End Heart Rate
Time frame: Measured at the end of heat exposure, 90 minutes from Cocaine/ lidocaine administration
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)
End Mean Arterial Pressure
Time frame: Measured at the end of heat exposure, 90 minutes from cocaine/ lidocaine administration
End Thermal Sensation
Time frame: These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cocaine and Lidocaine in people with Hyperthermia and Cocaine Use, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Core Temperature (time frame: Core temperature is measured at baseline and at 60 minutes of heat exposure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.