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Cocaine for Heat Regulation During Exercise

Phase 1 & 2

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period.

Awards & highlights

Study Summary

This trial tests how cocaine affects sweating and body temp during exercise in hot weather.

Who is the study for?

This trial is for healthy English speakers aged 18-50 with a BMI under 31 and normal blood pressure. It's not for those outside this age range, pregnant or breastfeeding women, smokers, recent drug abusers, anyone on pain meds, or people with heart, lung, liver, kidney or metabolic diseases.Check my eligibility

What is being tested?

The study tests how intranasal cocaine affects body temperature control and sweat rates during exercise in warm conditions compared to lidocaine (a numbing agent). Participants will be given these substances nasally before exercising.See study design

What are the potential side effects?

Cocaine can cause high blood pressure, increased heart rate, anxiety, overheating of the body during exercise which could lead to heat stroke. Lidocaine may cause local numbness and rarely allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes before exposure to warm environmental conditions, throughout 60 minutes of exercise, and during the 30 minute recovery period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in core body temperature

Secondary outcome measures

Change in blood pressure

Change in heart rate

Change in skin temperature

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CocaineExperimental Treatment1 Intervention

Prior to entering the warm environmental conditions the participant will receive cocaine intranasally at a dose no higher than 3 mg per kilogram body mass. This dose will be given only once.

Group II: LidocainePlacebo Group1 Intervention

Prior to entering the warm environmental conditions the participant will receive lidocaine intranasally at a dose no higher than 3 mg per kilogram body mass. This dose will be given only once.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cocaine

2018

Completed Phase 4

~320

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,715 Total Patients Enrolled

4 Trials studying Hyperthermia

180 Patients Enrolled for Hyperthermia

Media Library

Cocaine Clinical Trial Eligibility Overview. Trial Name: NCT05809453 — Phase 1 & 2

Hyperthermia Research Study Groups: Cocaine, Lidocaine

Hyperthermia Clinical Trial 2023: Cocaine Highlights & Side Effects. Trial Name: NCT05809453 — Phase 1 & 2

Cocaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05809453 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility requirements to join this clinical research?

"To qualify for this study, patients must have heat stroke and fall within the bounds of 18 to 50 years old. This clinical trial will be admitting a total of 20 participants."

Answered by AI

Are individuals currently being accepted for this trial?

"According to the records stored on clinicaltrials.gov, this specific trial has ceased recruiting patients as of March 29th 2023. Nevertheless, at present there are 169 other trials actively searching for participants."

Answered by AI

Is the enrollment age range for this clinical trial inclusive of individuals under 30?

"This clinical trial has narrow inclusion criteria, only allowing patients between 18 to 50 years of age. For those under 18 and over 65 there are 29 and 119 studies respectively that may be suitable for them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intranasal Cocaine and Temperature Regulation During Exercise

Craig Crandall 2023. "Intranasal Cocaine and Temperature Regulation During Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05809453.

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