AlcoholismNCT00477984
Effects of Alcohol on Simulated Driving
A study testing alcohol in people with Alcoholism, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Mar 2008
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- He/she is aged between 21-50
- Written informed consent
- Right-handed
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
- Social Drinker (average of 7 to 21 alcoholic drinks per week)
- Possession of a drivers license
- Be considered as reliable and mentally capable of adhering to the protocol.
Who cannot join
- Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
- Positive urine pregnancy drug screen in women
- Use of psychoactive medication
- Positive alcohol breath test
- Prior enrolment in the same study
- Physical or mental illness
Show all 9Show fewer
- Excessive alcohol use (>21 alcoholic drinks per week)
- Excessive smoking (more than 10 cigarettes per day)
- Intake of caffeine-containing beverages over 5 glasses per day
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Utrecht Institute for Pharmaceutical Sciences
Utrecht, Utrecht
About this study
Official title: The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials
Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.
- Conditions
- Alcoholism
- Being tested
- alcohol
- Keywords
- Alcohol, Driving, Multitasking, ERP, social drinkers
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcoholDrug
Also called alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | alcohol and placebo Receives: Drug: alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error).
Measured: 5 testdays
Secondary outcomes (1)
Reaction speed after hearing the deviant target tone. Brain activity: ERPs of interest are the mismatch negativity (MMN), P3a, P3b, and reorienting negativity (RON)
Measured: 5 testdays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Joris C Verster, PhD, Principal investigator, Utrecht Institute for Pharmaceutical SciencesEdmund R Volkerts, PhD, Study director, Utrecht Institute for Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477984
- Sponsor's protocol ID
- 06-221/O
- Status last verified
- Apr 2008
- First submitted
- 23 May 2007
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials
- ClinicalTrials.gov ID
- NCT00477984
- Acronym / sponsor ID
- 06-221/O
- Conditions
- Alcoholism
- Keywords
- Alcohol, Driving, Multitasking, ERP, social drinkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 24 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.
Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: alcoholalcohol and placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- He/she is aged between 21-50
- Written informed consent
- Right-handed
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
Key exclusion criteria (9 listed)
- Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
- Positive urine pregnancy drug screen in women
- Use of psychoactive medication
- Positive alcohol breath test
- Prior enrolment in the same study
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 |
|---|---|---|
| alcoholAlso: alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placeboalcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo | Drug | A |
Primary outcome
Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error).
Time frame: 5 testdays
1 secondary outcome
Reaction speed after hearing the deviant target tone. Brain activity: ERPs of interest are the mismatch negativity (MMN), P3a, P3b, and reorienting negativity (RON)
Time frame: 5 testdays
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 15 Apr 2008.
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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.
Joris C Verster, PhD principal investigator
Utrecht Institute for Pharmaceutical Sciences
Edmund R Volkerts, PhD study director
Utrecht Institute for Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alcohol in people with Alcoholism, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
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 8 inclusion and 9 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 15 Apr 2008. 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 Netherlands. 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. 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?
Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error). (time frame: 5 testdays). 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 15 Apr 2008.