CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Cocaine +1 moredrug
Likely dose
Cocaine hydrochloride 4% nasal solution, 3 mg/kg intranasallyAI-extracted
Key inclusion· 5
  • Age 18 to 50 years
  • Healthy status
  • Body mass index less than 31 kg/m²
  • Systolic blood pressure <140 mmHg
Key exclusion· 8
  • Cardiac, respiratory, neurological, or metabolic illness
  • History of renal or hepatic insufficiency/disease
  • Pregnancy or breast feeding
  • Body mass less than 60 kilograms

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05809453
NCT05809453Phase 2Completed

Intranasal Cocaine and Temperature Regulation During Exercise

University of Texas Southwestern Medical Center·interventional·Posted Apr 12, 2023·Updated Jul 14, 2025

In Brief

A Phase 2 clinical trial evaluating Cocaine and Lidocaine for Hyperthermia and 2 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedApr 12, 2023
Enrollment StartSep 1, 2023
Primary CompletionJun 5, 2024
Study CompletionAug 1, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago

Interventions

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.