Sports doping
Conditions
Interventions
Trade Name: TRAMADOL NORMON 50 mg Cápsulas EFG
Pharmaceutical Form: Capsule
INN or Proposed INN: TRAMADOL
Other descriptive name: TRAMADOL
Sponsors
Daniel Sanabria
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: To ensure the high-fit quality profile of the participants, male cyclists and triathletes with a above average of 90 percentile, according to normative values proposed by the American College of Sports Medicine, (16) will be recruited. Age will range from 18 to 40 years. -Signature of prior consent before any activity related to the study, including the necessary evaluations for the selection. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any selected subject that meets at least one of the following exclusion criteria may not be included in the study: - Allergy to tramadol or any of its excipients - Allergy to paracetamol or any of its excipients - Presence of any heart disease symptom - Metabolic disorder such as obesity (BMI> 30) or diabetes - Chronic obstructive pulmonary disease (COPD) - Epilepsy or risk of seizures, such as withdrawal syndrome - Active treatment with ß-blockers - Subjects under treatment with MAO inhibitors or who have received them during the last 14 days - Consumption of alcohol, tobacco or any other drug of abuse that could incapacitate him to participate in the study. - Diagnosis of any other pathology that, in the opinion of the investigator, may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to verify the effect of an acute dose of tramadol, compared to an acute dose of paracetamol and compared to placebo, on physical and cognitive performance in cyclists; Secondary Objective: 1. To investigate the effect of tramadol vs. paracetamol vs. placebo on physiological and subjective parameters related to cycling performance (1st and 2nd year). 2. To investigate the effect of tramadol vs. paracetamol vs. placebo on sustained attention (at the cognitive and brain levels) during cycling performance at constant load and during a self-paced indoor time trial (both on objective and subjective performance parameters) (1st and 2nd year). 3. To investigate the effect of tramadol vs. paracetamol vs. placebo on cycling performance during short maximal intensity efforts (1st and 2nd year) using repeated 30 seconds Wingate cycling tests. ; Primary end point(s): Recruitment Pilot Data collection Data Analysis ; Timepoint(s) of evaluation of this end point: Recruitment, month 13 Pilot, month 6 Data collection, month 18 Data Analysis, month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no secondary end points;Timepoint(s) of evaluation of this end point: There are no secondary end points | — |
Countries
Spain
Contacts
Public ContactSARAH BIEL
FIBAO
Outcome results
None listed