Opioid UseNCT03934411
Effect of Increased Pain Tolerance on Exercise Performance
A study testing Tramadol in people with Opioid Use and Exercise, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Clinical prescription and use of opioids is a clear problem in large parts of the world and has the recent years received an increasing publicity in sports. This is in particular due to the World Anti-Doping Agency monitoring list, which reveal that endurance athletes utilize the opioid Tramadol frequently with the… Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Exercise
- What is being tested?
- Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2018to 7 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maximal oxygen uptake < 55 ml O2/min/kg
- Plasma creatinine concentration between 60-105 umol/L
- Plasma alanine aminotransferase between 10-70 U/L
- Familiarized with endurance training for at least a few years
Who cannot join
- Donated blood within the last 3 months
- Exposed to an altitude greater than 1000 m above sea level within the last two months
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Clinical prescription and use of opioids is a clear problem in large parts of the world and has the recent years received an increasing publicity in sports. This is in particular due to the World Anti-Doping Agency monitoring list, which reveal that endurance athletes utilize the opioid Tramadol frequently with the aim to enhance performance according to anecdotal evidence.
Studies investigating the effect of tramadol on exercise performance in healthy humans is limited to one study in moderate trained subjects. However, this effect may be different in highly trained subjects due to the effects of chronic exercise. Furthermore, ingestion of tramadol may impact motor-cognitive performance and it remains unknown whether tramadol can be detected in highly trained subjects following exercise.
In the present study the investigators apply a randomized double-blind placebo-controlled counterbalanced cross-over design to investigate whether tramadol treatment improves a preloaded cycling time trial performance, whether it affects motor-cognitive performance and whether it is detectable following exercise.
- Conditions
- Opioid Use, Exercise
- Being tested
- Tramadol, Placebo
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
The subjects will orally ingest 100 mg tramadol retard actavis
PlaceboOther
The subjects will orally ingest 100 mg calcium powder
| Study group | Role | What they receive |
|---|---|---|
| Tramadol treatment | Experimental | Not described Receives: Drug: Tramadol |
| Placebo treatment | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power output
Mean power output during a 15-km time trial
Measured: 30 minutes
Motor-cognitive performance
The motor-cognitive performance evaluated by mathematical calculations combined with the ability to pinch a certain force with the thumb and index finger
Measured: 1 hour
Detection rate
The detection rate of tramadol following the exercise intervention measured before, immediately after as well as 6 and 24h after treatment
Measured: 1 day
Secondary outcomes (14)
pH
The response of blood pH to exercise performance
Measured: 90 min
Lactate
The response of blood lactate to exercise performance
Measured: 90 min
Bicarbonate
The response of blood bicarbonate to exercise performance
Measured: 90 min
Glucose
The response of blood glucose to exercise performance
Measured: 90 min
Potassium
The response of blood potassium to exercise performance
Measured: 90 min
Sodium
The response of blood sodium to exercise performance
Measured: 90 min
Oxygen uptake
The response of systemic oxygen uptake during exercise performance
Measured: 90 min
Pulmonary ventilation
The response of pulmonary ventilation during exercise performance.
Measured: 90 min
Respiratory exchange ratio
The response of respiratory exchange ratio during exercise performance, calculated as the ratio between system oxygen uptake and systemic carbon monoxide production. The unit of measure is arbitrary.
Measured: 90 min
Rate of Perceived Exertion
Measurement of the rate of perceived exertion by questionnaire during exercise performance using "The borg scale of perceived exertion", which range from 6 (minimum value) to 20 (maximum value). Higher values represent a higher perceived exertion.
Measured: 90 min
Leg Pain
Measurement of the leg pain by questionnaire during exercise performance using the "10-point pain scale", which range from 0 (minimum) to 10 (maximum). Higher values represent a higher pain.
Measured: 90 min
Heart rate
The response of heart rate to exercise performance
Measured: 90 min
Power output during preload
Mean power output during a 60-min cycling exercise
Measured: 60 min
Power output during time trial
The power output measured for each km of the time trial
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Mar 2018
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Anti Doping Danmark, Oslo University Hospital
- Responsible party
- Principal investigator, Nikolai Nordsborg, University of Copenhagen
- Investigators
- Nikolai B Nordsborg, Dr, Principal investigator, Department of Nutrition, Exercise and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934411
- Sponsor's protocol ID
- H-17028397
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Pain Tolerance on Exercise Performance
- ClinicalTrials.gov ID
- NCT03934411
- Acronym / sponsor ID
- H-17028397
- Conditions
- Opioid Use, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Anti Doping Danmark, Oslo University Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical prescription and use of opioids is a clear problem in large parts of the world and has the recent years received an increasing publicity in sports. This is in particular due to the World Anti-Doping Agency monitoring list, which reveal that endurance athletes utilize the opioid Tramadol frequently with the aim to enhance performance according to anecdotal evidence.
Studies investigating the effect of tramadol on exercise performance in healthy humans is limited to one study in moderate trained subjects. However, this effect may be different in highly trained subjects due to the effects of chronic exercise. Furthermore, ingestion of tramadol may impact motor-cognitive performance and it remains unknown whether tramadol can be detected in highly trained subjects following exercise.
In the present study the investigators apply a randomized double-blind placebo-controlled counterbalanced cross-over design to investigate whether tramadol treatment improves a preloaded cycling time trial performance, whether it affects motor-cognitive performance and whether it is detectable following exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol treatment | Experimental | Drug: Tramadol |
| Placebo treatment | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Maximal oxygen uptake < 55 ml O2/min/kg
- Plasma creatinine concentration between 60-105 umol/L
- Plasma alanine aminotransferase between 10-70 U/L
- Familiarized with endurance training for at least a few years
Key exclusion criteria (3 listed)
- Donated blood within the last 3 months
- Exposed to an altitude greater than 1000 m above sea level within the last two months
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramadolThe subjects will orally ingest 100 mg tramadol retard actavis | Drug | Tramadol treatment |
| PlaceboThe subjects will orally ingest 100 mg calcium powder | Other | Placebo treatment |
Primary outcome
Power output
Time frame: 30 minutes
Mean power output during a 15-km time trial
Motor-cognitive performance
Time frame: 1 hour
The motor-cognitive performance evaluated by mathematical calculations combined with the ability to pinch a certain force with the thumb and index finger
Detection rate
Time frame: 1 day
The detection rate of tramadol following the exercise intervention measured before, immediately after as well as 6 and 24h after treatment
14 secondary outcomes
pH
Time frame: 90 min
Lactate
Time frame: 90 min
Bicarbonate
Time frame: 90 min
Glucose
Time frame: 90 min
Potassium
Time frame: 90 min
Sodium
Time frame: 90 min
Oxygen uptake
Time frame: 90 min
Pulmonary ventilation
Time frame: 90 min
Respiratory exchange ratio
Time frame: 90 min
Rate of Perceived Exertion
Time frame: 90 min
Leg Pain
Time frame: 90 min
Heart rate
Time frame: 90 min
Power output during preload
Time frame: 60 min
Power output during time trial
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolai B Nordsborg, Dr principal investigator
Department of Nutrition, Exercise and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol in people with Opioid Use and Exercise, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power output (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019; AzTrials last refreshed its copy on 30 Oct 2026.