Use of tramadol in healthy volunteers. Effects on physical performance and sustained attention in cycling.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005056-96-ES

Enrollment

Unknown

Registered

2016-01-13

Start date

2016-05-31

Completion date

Unknown

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sport doping MedDRA version: 18.1 Level: LLT Classification code 10076471 Term: Drug doping System Organ Class: 100000004873

Interventions

Trade Name: Tramadol Normon 50mg Cápsulas EFG Product Name: TRAMADOL Pharmaceutical Form: Capsule INN or Proposed INN: TRAMADOL CAS Number: 27203-92-5 Other descriptive name: TRAMADOL HYDROCHLORIDE Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Signed informed consent before any activity related with the study, including assessments required for the selection. - Age between 18 and 35 years inclusive. - If women would find no confirmation pregnant or breastfeeding and commitment to use adequate contraception as hormonal contraception, intrauterine device or barrier methods (vaginal condom or diaphragm) along the entire study period. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Allergy to tramadol or any of the excipients - Any symptoms of heart disease - Metabolic disorder such as obesity (BMI> 30) or diabetes - Chronic obstructive pulmonary disease (COPD) - Epilepsy or seizure risk as withdrawal - Active treatment with beta-blockers - Patients treated with MAO inhibitors or that they have received Over the past 14 days - Consumption of alcohol, snuff or other drugs of abuse that could incapacitate to participate in the study. - Diagnosis of any other condition that the investigator's opinion, may increase the risk of the subject or reduce the chances of obtaining data satisfactory to achieve the objectives of the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the effect of an acute dose of tramadol compared to placebo, in the physical and cognitive performance in cyclists;Primary end point(s): Sustained attention test;Timepoint(s) of evaluation of this end point: 20 minutes;Secondary Objective: 1. Evaluate the effect of tramadol versus placebo in physiological indices and subjective related to cycling performance. 2. Evaluate the effects of tramadol versus placebo in sustained attention at basal status. 3. Assess the effects of tramadol versus placebo in sustained attention in an effort to functional threshold power cycling.	—

Measure

Time frame

Main Objective: To compare the effect of an acute dose of tramadol compared to placebo, in the physical and cognitive performance in cyclists;Primary end point(s): Sustained attention test;Timepoint(s) of evaluation of this end point: 20 minutes;Secondary Objective: 1. Evaluate the effect of tramadol versus placebo in physiological indices and subjective related to cycling performance. 2. Evaluate the effects of tramadol versus placebo in sustained attention at basal status. 3. Assess the effects of tramadol versus placebo in sustained attention in an effort to functional threshold power cycling.

—

Secondary

Measure	Time frame
Secondary end point(s): - Heart Rate - VO2 - VCO2 - Cerebral activity - Subjetive performance;Timepoint(s) of evaluation of this end point: 20 minutes	—

Countries

Spain

Contacts

Public ContactEmilio García Cabrera

Delos Clinical

emiliogcabrera@delosclinical.com0034655843699

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026