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Phase 2 Completed N=24 Randomized Single-blind Basic Science

Intranasal Cocaine and Temperature Regulation During Exercise

Hyperthermia · Cocaine Use · Exercise
Source: ClinicalTrials.gov NCT05809453 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Change in Core Temperature — 1.19; 1.09; 1.20; 0.89 Celsius

Summary

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

Outcome Measures

OutcomeResultp-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 —

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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