Caffeine-mediated modulation of human experimental pain models

Conditions: Healthy human volunteer subjects

Registration Number: EUCTR2005-000408-16-SE

Lead Sponsor: Karolinska University Hospital, Huddinge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Both male and female subjects between the age of 18 and 55 will be included.

Subjects should be healthy without on-going long-term medication.

All participation will be on voluntary basis and informed written and verbal consent will be acquired from all subjects.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·History of any disease that might influence results or cause increased danger or discomfort to the subject. Especially, previous history of cardiac arrhythmias, long-term pain disorder or sleep or mood disorders.

·Consumption of caffeine or xanthine containing beverages and foodstuffs, e.g. tea, chocolate and certain soft drinks in excess of 300 mg/day, corresponding to more than 3-4 cups of coffee/day.

·Any acute signs of illness or infection one week before experiment.

·Overweight, BMI >30.

·Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A. To study the analgesic properties of caffeine, and primarily determine the site of action, peripheral or central, by use of a tourniquet model for ischemic pain.<br><br>B. To study the analgesic and anti-inflammatory properties of caffeine after a skin burn injury. Any changes in secondary hyperalgesia are of special interest.<br>;Secondary Objective: ;Primary end point(s):

Secondary Outcome Measures