Trial Outcomes & Findings for Intranasal Cocaine and Temperature Regulation During Exercise (NCT NCT05809453)
NCT ID: NCT05809453
Last Updated: 2025-07-14
Results Overview
Core temperature will be measured either from a temperature sensor pill or from a rectal temperature probe.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Core temperature is measured at baseline and at 60 minutes of heat exposure.
Results posted on
2025-07-14
Participant Flow
3 participants who signed the consent were withdrawn from the study prior to visit 1 due to either elevated bp at screening visit or they started a new medication that disqualified them from participating in this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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
7
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Intranasal Cocaine and Temperature Regulation During Exercise
Baseline characteristics by cohort
| Measure |
Hot-Humid: Cocaine First Then Lidocaine
n=6 Participants
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.
|
Hot-Humid: Lidocaine First Then Cocaine
n=7 Participants
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.
|
Hot-Dry: Cocaine First Then Lidocaine
n=6 Participants
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.
|
Hot-Dry: Lidocaine First Then Cocaine
n=4 Participants
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.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 5 • n=5 Participants
|
32 years
STANDARD_DEVIATION 3 • n=7 Participants
|
28 years
STANDARD_DEVIATION 7 • n=5 Participants
|
28 years
STANDARD_DEVIATION 4 • n=4 Participants
|
30 years
STANDARD_DEVIATION 5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Hot-Humid: Cocaine
n=13 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.
|
Hot-Humid: Lidocaine
n=13 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.
|
Hot-Dry: Cocaine
n=10 Participants
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.
|
Hot-Dry: Lidocaine
n=10 Participants
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.
|
|---|---|---|---|---|
|
Change in Core Temperature
|
1.19 Celsius
Standard Deviation 0.32
|
1.09 Celsius
Standard Deviation 0.33
|
1.20 Celsius
Standard Deviation 0.27
|
0.89 Celsius
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Measured at the end of heat exposure, 90 minutes from cocaine/lidocaine administrationSkin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin
Outcome measures
| Measure |
Hot-Humid: Cocaine
n=13 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.
|
Hot-Humid: Lidocaine
n=13 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.
|
Hot-Dry: Cocaine
n=10 Participants
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.
|
Hot-Dry: Lidocaine
n=10 Participants
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.
|
|---|---|---|---|---|
|
End Skin Temperature
|
35.83 Celsius
Standard Deviation 0.44
|
35.57 Celsius
Standard Deviation 0.59
|
35.80 Celsius
Standard Deviation 0.81
|
35.39 Celsius
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Measured at the end of heat exposure, 90 minutes from Cocaine/ lidocaine administrationHeart rate will be measured from ECG electrodes attached to the participant
Outcome measures
| Measure |
Hot-Humid: Cocaine
n=13 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.
|
Hot-Humid: Lidocaine
n=13 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.
|
Hot-Dry: Cocaine
n=10 Participants
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.
|
Hot-Dry: Lidocaine
n=10 Participants
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.
|
|---|---|---|---|---|
|
End Heart Rate
|
151 BPM
Standard Deviation 21
|
147 BPM
Standard Deviation 18
|
147 BPM
Standard Deviation 20
|
134 BPM
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 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)Whole body sweat rate is calculated by subtracting the participants post-heat exposure nude body weight from their pre-heat exposure nude body weight
Outcome measures
| Measure |
Hot-Humid: Cocaine
n=13 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.
|
Hot-Humid: Lidocaine
n=13 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.
|
Hot-Dry: Cocaine
n=10 Participants
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.
|
Hot-Dry: Lidocaine
n=10 Participants
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.
|
|---|---|---|---|---|
|
Whole Body Sweat Rate
|
0.83 L/hour
Standard Deviation 0.25
|
0.79 L/hour
Standard Deviation 0.27
|
0.79 L/hour
Standard Deviation 0.15
|
0.84 L/hour
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Measured at the end of heat exposure, 90 minutes from cocaine/ lidocaine administrationSystolic and diastolic blood pressure will be measured from a cuff placed on the upper arm.
Outcome measures
| Measure |
Hot-Humid: Cocaine
n=13 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.
|
Hot-Humid: Lidocaine
n=13 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.
|
Hot-Dry: Cocaine
n=10 Participants
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.
|
Hot-Dry: Lidocaine
n=10 Participants
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.
|
|---|---|---|---|---|
|
End Mean Arterial Pressure
|
85 mmHg
Standard Deviation 7
|
89 mmHg
Standard Deviation 8
|
86 mmHg
Standard Deviation 10
|
87 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: These values will be obtained at end of the 60 minute heat exposure (90 minutes post cocaine/ lidocaine administration)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
Outcome measures
| Measure |
Hot-Humid: Cocaine
n=13 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.
|
Hot-Humid: Lidocaine
n=13 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.
|
Hot-Dry: Cocaine
n=10 Participants
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.
|
Hot-Dry: Lidocaine
n=10 Participants
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.
|
|---|---|---|---|---|
|
End Thermal Sensation
|
31 units on a scale
Standard Deviation 14
|
37 units on a scale
Standard Deviation 9
|
26 units on a scale
Standard Deviation 12
|
27 units on a scale
Standard Deviation 15
|
Adverse Events
Hot-Humid: Cocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hot-Humid: Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hot-Dry: Cocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hot-Dry: Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place