Phase 2
N=24
Intranasal Cocaine and Temperature Regulation During Exercise
Hyperthermia · Cocaine Use · Exercise
Bottom Line
View on ClinicalTrials.gov: NCT05809453 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Core Temperature — 1.19; 1.09; 1.20; 0.89 Celsius
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cocaine (Drug); Lidocaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Core Temperature |
1.19; 1.09; 1.20; 0.89 | — |
| SECONDARY End Skin Temperature |
35.83; 35.57; 35.80; 35.39 | — |
| SECONDARY End Heart Rate |
151; 147; 147; 134 | — |
| SECONDARY Whole Body Sweat Rate |
0.83; 0.79; 0.79; 0.84 | — |
| SECONDARY End Mean Arterial Pressure |
85; 89; 86; 87 | — |
| SECONDARY End Thermal Sensation |
31; 37; 26; 27 | — |
Summary
Assess the effects of intranasal cocaine on temperature regulation and whole-body sweat rate during exercise in warm environmental conditions.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05809453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.