SleepPhase 2NCT00247585
Hangover, Congeners, Sleep and Occupational Performance
A Phase 2 study testing Ethanol (Bourbon or Vodka) in people with Sleep and Neurobehavioral Manifestations, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
The objective is to investigate residual effects of heavy drinking, with or without hangover symptoms. The primary aim is to test several hypotheses about residual effects of heavy drinking. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Neurobehavioral Manifestations
- What is being tested?
- Ethanol (Bourbon or Vodka)
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2006
- Phase
- Phase 2
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 21-30
- Currently enrolled or have completed college/university
- Have had 5 or more drinks (4 if female) in the last 30 days
- Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST)
- No self-reported history of counseling or treatment for substance abuse
- Not taking any medication contraindicated for alcohol use or that disrupts sleep
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- Doesn't have a health condition contraindicated for alcohol use
- Has not been diagnosed with a primary sleep disorder
- Has not been diagnosed with a mental health disorder
- Not currently working night shifts at a job
- Not routinely taking medications that affect sleep
- No evidence of extreme morningness or eveningness as assessed by questionnaire
- Not a regular smoker
Who cannot join
- Less than age 21 and greater than age 30
- Not currently enrolled or has not completed college/university
- Hasn't had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker)
- Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST)
- Self-reported history of counseling or treatment for substance abuse
- Taking any medication contraindicated for alcohol use or that disrupts sleep
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- Has a health condition contraindicated for alcohol use
- Has been diagnosed with a primary sleep disorder
- Has been diagnosed with a mental health disorder
- Currently working night shifts at a job
- Routinely taking medications that affect sleep
- Evidence of extreme morningness or eveningness as assessed by questionnaire
- Is a regular smoker
- Not a regular drinker
- Is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center, Boston University School of Public Health/Boston Medical Center
Boston, Massachusetts, 02118
About this study
The objective is to investigate residual effects of heavy drinking, with or without hangover symptoms. The primary aim is to test several hypotheses about residual effects of heavy drinking. Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol, alcohol withdrawal effects, and non-ethanol effects, such as congeners, or family history of alcohol problems. The investigators will test the following hypotheses:
- relative to placebo, heavy drinking will degrade next-day performance, and this relationship will be mediated in full or in part by quality of sleep;
- a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms.
Read the detailed description
The primary aim of the proposed study is to test several hypotheses about residual effects of heavy drinking. Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol (e.g., electrolyte imbalance, low blood sugar, sleep disturbance), alcohol withdrawal effects, acetaldehyde toxicity, and non-ethanol effects, such as congeners or family history of alcohol (Swift and Davidson, 1998). Using a placebo-controlled randomized trial, we will dose participants with placebo or with a high or low congener alcoholic beverage (to a level of 0.10 g% BAC) the night before they perform exercises on a neurobehavioral evaluation system. We will monitor participants' sleep to assess sleep disturbance. We will collect information on hangover symptoms the morning after dosing. We will also collect data on participants' family history of drinking problems. We will test the following hypotheses:
- relative to placebo, heavy drinking will degrade next-day cognitive performance, and this relationship will be mediated in full or in part by quality of sleep; and
- a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms.
We will explore whether the residual effects of heavy drinking on next-day cognitive performance are attenuated among participants positive for a family history of alcohol problems, relative to family-history-negative participants.
A secondary aim is to test the effectiveness of the Psychomotor Vigilance Test (PVT), a validated measure of fatigue, as a fitness-for-duty test. We will test whether the PVT can distinguish dosing status (alcohol or placebo) of participants at the time performance is measured the next day and the extent to which PVT measures correlate with performance scores.
Participants will be young adults ages 21-30 who are currently enrolled in an undergraduate college or university or have graduated from a college or university. Alcoholic beverages will be bourbon (high-congener) in soda or vodka (low-congener) in soda. Placebo will be tonic alone. We will use a mixed within- and between-subjects design, balancing the order of placebo and alcohol administration. Performance will be measured using a computer-based neurobehavioral evaluation system.
- Conditions
- Sleep, Neurobehavioral Manifestations
- Being tested
- Ethanol (Bourbon or Vodka)
- Keywords
- Alcohol, Alcohol abuse, Alcohol consumption, Unhealthy alcohol use, Residual effects, Sleep Stages, Respiratory Physiology
- Medical subject headings
- Neurobehavioral Manifestations, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol (Bourbon or Vodka)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function in response to heavy drinking
Cognitive function in response to sleep quality
Self-reported residual effects of heavy drinking
Secondary outcomes (1)
Effectiveness of psychomotor vigilance testing as a fitness-for-duty test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startSep 2003
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jonathan Howland, PhD, MPH, MPA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247585
- Sponsor's protocol ID
- NIAAAHOW12087
- Other IDs
- NIH Grant R01 AA12087-04A1
- Status last verified
- Dec 2006
- First submitted
- 1 Nov 2005
- Last updated
- 6 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hangover, Congeners, Sleep and Occupational Performance
- ClinicalTrials.gov ID
- NCT00247585
- Acronym / sponsor ID
- NIAAAHOW12087
- Conditions
- Sleep, Neurobehavioral Manifestations
- Keywords
- Alcohol, Alcohol abuse, Alcohol consumption, Unhealthy alcohol use, Residual effects, Sleep Stages, Respiratory Physiology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- Sep 2003
- Study completion
- Jun 2006
- First posted
- 2 Nov 2005 (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.
The objective is to investigate residual effects of heavy drinking, with or without hangover symptoms. The primary aim is to test several hypotheses about residual effects of heavy drinking. Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol, alcohol withdrawal effects, and non-ethanol effects, such as congeners, or family history of alcohol problems. The investigators will test the following hypotheses:
- relative to placebo, heavy drinking will degrade next-day performance, and this relationship will be mediated in full or in part by quality of sleep;
- a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms.
Detailed description
The primary aim of the proposed study is to test several hypotheses about residual effects of heavy drinking. Hypotheses about how heavy drinking affects next-day performance include direct physiological effects of alcohol (e.g., electrolyte imbalance, low blood sugar, sleep disturbance), alcohol withdrawal effects, acetaldehyde toxicity, and non-ethanol effects, such as congeners or family history of alcohol (Swift and Davidson, 1998). Using a placebo-controlled randomized trial, we will dose participants with placebo or with a high or low congener alcoholic beverage (to a level of 0.10 g% BAC) the night before they perform exercises on a neurobehavioral evaluation system. We will monitor participants' sleep to assess sleep disturbance. We will collect information on hangover symptoms the morning after dosing. We will also collect data on participants' family history of drinking problems. We will test the following hypotheses:
- relative to placebo, heavy drinking will degrade next-day cognitive performance, and this relationship will be mediated in full or in part by quality of sleep; and
- a high congener alcoholic beverage will affect performance to a greater degree than a low congener beverage and this relationship will be mediated by severity of hangover symptoms.
We will explore whether the residual effects of heavy drinking on next-day cognitive performance are attenuated among participants positive for a family history of alcohol problems, relative to family-history-negative participants.
A secondary aim is to test the effectiveness of the Psychomotor Vigilance Test (PVT), a validated measure of fatigue, as a fitness-for-duty test. We will test whether the PVT can distinguish dosing status (alcohol or placebo) of participants at the time performance is measured the next day and the extent to which PVT measures correlate with performance scores.
Participants will be young adults ages 21-30 who are currently enrolled in an undergraduate college or university or have graduated from a college or university. Alcoholic beverages will be bourbon (high-congener) in soda or vodka (low-congener) in soda. Placebo will be tonic alone. We will use a mixed within- and between-subjects design, balancing the order of placebo and alcohol administration. Performance will be measured using a computer-based neurobehavioral evaluation system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Ages 21-30
- Currently enrolled or have completed college/university
- Have had 5 or more drinks (4 if female) in the last 30 days
- Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST)
- No self-reported history of counseling or treatment for substance abuse
Key exclusion criteria (15 listed)
- Less than age 21 and greater than age 30
- Not currently enrolled or has not completed college/university
- Hasn't had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker)
- Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST)
- Self-reported history of counseling or treatment for substance abuse
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 |
|---|---|---|
| Ethanol (Bourbon or Vodka) | Drug | – |
Primary outcome
Cognitive function in response to heavy drinking
Cognitive function in response to sleep quality
Self-reported residual effects of heavy drinking
1 secondary outcome
Effectiveness of psychomotor vigilance testing as a fitness-for-duty test
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 6 Dec 2006.
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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.
Jonathan Howland, PhD, MPH, MPA principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethanol (Bourbon or Vodka) in people with Sleep and Neurobehavioral Manifestations, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
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 13 inclusion and 15 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 6 Dec 2006. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cognitive function in response to heavy drinking. 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 6 Dec 2006.