HealthyNCT00477178
The Effect of Codeine on Driving Abilities
An observational study of Healthy, run by Norwegian University of Science and Technology.
Trial summary
20 chronic pain patients using codeine are compared with 20 chronic patients not using opioids and 20 healthy volunteers with respect to driving ability measured by neurophysiological tests and driving in a car simulator. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Dec 2005
- Phase
- Observational
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: chronic pain patients driving more than 50,000 km/yr
Who may be able to join
- patients with chronic pain
- driving more than 50 000 km
Who cannot join
- addiction
- eyesight disorders
About this study
20 chronic pain patients using codeine are compared with 20 chronic patients not using opioids and 20 healthy volunteers with respect to driving ability measured by neurophysiological tests and driving in a car simulator.
- Conditions
- Healthy
- Keywords
- possible problems using codeine when driving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic non-malignant pain codeine | patients having chronic non-malignant pain, living in Trondheim or the four adjacent counties and treated at the Center for Pain and Complex Disorders at St. Olav University Hospital - on long-term codeine therapy | |
| chronic non-malignant pain | patients having chronic non-malignant pain, living in Trondheim or the four adjacent counties and treated at the Center for Pain and Complex Disorders at St. Olav University Hospital - NOT on long-term codeine therapy | |
| healthy | healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startAug 2004
- Primary completionMay 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Investigators
- Petter C Borchgrevink, Professor, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477178
- Sponsor's protocol ID
- 133-04REK
- Status last verified
- May 2007
- First submitted
- 21 May 2007
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsen HK, Landro NI, Kaasa S, Jenssen GD, Fayers P, Borchgrevink PC. Driving functions in a video simulator in chronic non-malignant pain patients using and not using codeine. Eur J Pain. 2011 Apr;15(4):409-15. doi: 10.1016/j.ejpain.2010.09.008. Epub 2010 Oct 13.
PubMed 20947399
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Codeine on Driving Abilities
- ClinicalTrials.gov ID
- NCT00477178
- Acronym / sponsor ID
- 133-04REK
- Conditions
- Healthy
- Keywords
- possible problems using codeine when driving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- May 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 22 May 2007 (estimated)
- 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.
20 chronic pain patients using codeine are compared with 20 chronic patients not using opioids and 20 healthy volunteers with respect to driving ability measured by neurophysiological tests and driving in a car simulator.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic non-malignant pain codeine | – | –patients having chronic non-malignant pain, living in Trondheim or the four adjacent counties and treated at the Center for Pain and Complex Disorders at St. Olav University Hospital - on long-term codeine therapy |
| chronic non-malignant pain | – | –patients having chronic non-malignant pain, living in Trondheim or the four adjacent counties and treated at the Center for Pain and Complex Disorders at St. Olav University Hospital - NOT on long-term codeine therapy |
| healthy | – | –healthy controls |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- chronic pain patients driving more than 50,000 km/yr
Key inclusion criteria (2 listed)
- patients with chronic pain
- driving more than 50 000 km
Key exclusion criteria (2 listed)
- addiction
- eyesight disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Aug 2011.
- Results publication: PubMed 20947399Nilsen HK, Landro NI, Kaasa S, Jenssen GD, Fayers P, Borchgrevink PC. Driving functions in a video simulator in chronic non-malignant pain patients using and not using codeine. Eur J Pain. 2011 Apr;15(4):409-15. doi: 10.1016/j.ejpain.2010.09.008. Epub 2010 Oct 13.
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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.
Petter C Borchgrevink, Professor study chair
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Norwegian University of Science and Technology.
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 2 inclusion and 2 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 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477178, which also lists 1 linked publication.
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 10 Aug 2011.