Alcoholic IntoxicationPhase 2NCT00183170
Residual Effects of Intoxication on Student Performance
A Phase 2 study testing Alcohol in people with Alcoholic Intoxication and Neurobehavioral Manifestations, run by Boston University at 1 site in United States.
Trial summary
The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Intoxication, Neurobehavioral Manifestations
- What is being tested?
- Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 in 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
- If female, is using reliable birth control when necessary
- Not a regular smoker
- Likes the taste of beer
Who cannot join
- Less than age 21 and greater than age 30
- Not currently enrolled in 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
- Is a regular smoker
- Is currently pregnant or nursing
- If female, is not using reliable birth control when necessary
- Not a regular drinker
- Dislikes the taste of beer
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center/Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The primary hypothesis is that intoxication (0.10 g% blood alcohol concentration [BAC]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. The secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.
Read the detailed description
The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. A placebo-controlled 2-period crossover design will be used to compare the effects of dosing status on academic performance, with participants serving as their own controls. Participants are dosed on two separate occasions, once with non-alcoholic beverage and the other time with alcoholic beverage sufficient to raise blood alcohol to 0.10 g%. The morning after dosing, participants' academic performance is measured using a standardized achievement test (Graduate Record Exam). Participants' cognition is tested using the the Psychomotor Vigilance Test (PVT). Data on participants' demographics, family history of drinking problems and alcohol use. We are also collecting information on hangover symptoms and sleep quality the morning after dosing, in addition to participants' self ratings of academic performance. The procedure is conducted twice with one week in between, switching the individuals' dosing status, presenting a different, but comparable lecture and reading, and administering a different quiz based on the new lecture and reading and a different, but comparable standardized achievement exam. This design is intended to test the hypothesis that intoxication (0.10 g% BAC) with alcoholic beverage impairs next-day academic performance.
Participation involves a total of five sessions over a two week period. Participants are undergraduates who volunteer and meet inclusion criteria. Prior to enrollment, volunteers are screened to ensure they meet initial eligibility criteria. Eligible volunteers receive written instructions regarding participation and are scheduled for the study sessions. Participants report to the study site on the first session for an additional screening by the study physician and go through the informed consent process. Eligible participants report back the next week for their first dosing night where they receive several drinks (alcohol or placebo) sufficient to raise their Breath Alcohol Level (BrAC) to 0.10 g%; the amount of beverage administered is based on their body weight. Those receiving placebo receive the same total quantity of beverage as those receiving alcohol. Both alcohol-dosed and placebo-dosed participants are breath-tested after they have completed their required dose. Participants sleep at the study site and are monitored overnight. The next morning they are awakened and are escorted to the exam room for the performance trials. They return the next week for the second dosing night/dosing morning, and receive either alcohol or placebo, depending on what was administered the previous week, and take different but comparable performance tests.
- Being tested
- Alcohol, Placebo
- Keywords
- Alcohol abuse, Alcoholic beverages (beer), Residual effects, Psychomotor performance, Psychomotor vigilance test, Neurobehavioral Evaluation System, Family history of alcohol use, Alcoholic Consumption, Unhealthy alcohol use, Alcohol
- Medical subject headings
- Alcoholic Intoxication, Neurobehavioral Manifestations, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Also called Beer
Participants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks.
PlaceboOther
Also called Non-alcoholic drink
Participants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol then Placebo | Experimental | Participants report for their first dosing night where they receive several alcohol drinks. After a wash out period of 1 week they then return and receive several placebo drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials. Receives: Drug: Alcohol; Other: Placebo |
| Placebo then Alcohol | Experimental | Participants report for their first night where they receive several placebo drinks. After a wash out period of 1 week they then return and receive several alcohol drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials. Receives: Drug: Alcohol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Residual Effects of Heavy Drinking
This outcome will be measured by the afternoon total mood disturbance score. This is part of the Profile of Mood States Questionnaire (POMS). POMS is a 35 item instrument with Likert responses from 0 to 4 where 0=not at all and 4=extremely. Range of scores can be 0 to 140, lower scores are more favorable.
Measured: next day
Secondary outcomes (4)
Cognitive Function in Response to Heavy Drinking
This outcome measure will be assessed using the Visual Span Test- Backwards (VST-B). This is the mean maximum span of words repeated backwards correctly. Higher scores are more favorable
Measured: next day
Academic Function in Response to Heavy Drinking
This outcome will be measured by the mean Graduate Record Exam (GRE) quantitative score. The quantitative score can range from 200-800. Higher scores are more favorable.
Measured: next day
Reaction Time Affected by Residual Effects of Heavy Drinking
This outcome will be measured with the Continuous Performance Test (CPT) for reaction time in mean milliseconds (ms). Lower reaction times are more favorable.
Measured: next day
Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
This outcome will be assessed with the Psychomotor Vigilance Test (PVT) in median milliseconds. The 10-min PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Lower number of milliseconds are associated with greater vigilant attention.
Measured: next day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jonathan Howland, PhD MPH MPA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183170
- Sponsor's protocol ID
- H-23064
- Other IDs
- P60AA013759
- Status last verified
- Dec 2020
- First submitted
- 13 Sep 2005
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rohsenow DJ, Howland J, Winter M, Bliss CA, Littlefield CA, Heeren TC, Calise TV. Hangover sensitivity after controlled alcohol administration as predictor of post-college drinking. J Abnorm Psychol. 2012 Feb;121(1):270-5. doi: 10.1037/a0024706. Epub 2011 Aug 22.
PubMed 21859168
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Effects of Intoxication on Student Performance
- ClinicalTrials.gov ID
- NCT00183170
- Acronym / sponsor ID
- H-23064
- Keywords
- Alcohol abuse, Alcoholic beverages (beer), Residual effects, Psychomotor performance, Psychomotor vigilance test, Neurobehavioral Evaluation System, Family history of alcohol use, Alcoholic Consumption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2004 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The primary hypothesis is that intoxication (0.10 g% blood alcohol concentration [BAC]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. The secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.
Detailed description
The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. A placebo-controlled 2-period crossover design will be used to compare the effects of dosing status on academic performance, with participants serving as their own controls. Participants are dosed on two separate occasions, once with non-alcoholic beverage and the other time with alcoholic beverage sufficient to raise blood alcohol to 0.10 g%. The morning after dosing, participants' academic performance is measured using a standardized achievement test (Graduate Record Exam). Participants' cognition is tested using the the Psychomotor Vigilance Test (PVT). Data on participants' demographics, family history of drinking problems and alcohol use. We are also collecting information on hangover symptoms and sleep quality the morning after dosing, in addition to participants' self ratings of academic performance. The procedure is conducted twice with one week in between, switching the individuals' dosing status, presenting a different, but comparable lecture and reading, and administering a different quiz based on the new lecture and reading and a different, but comparable standardized achievement exam. This design is intended to test the hypothesis that intoxication (0.10 g% BAC) with alcoholic beverage impairs next-day academic performance.
Participation involves a total of five sessions over a two week period. Participants are undergraduates who volunteer and meet inclusion criteria. Prior to enrollment, volunteers are screened to ensure they meet initial eligibility criteria. Eligible volunteers receive written instructions regarding participation and are scheduled for the study sessions. Participants report to the study site on the first session for an additional screening by the study physician and go through the informed consent process. Eligible participants report back the next week for their first dosing night where they receive several drinks (alcohol or placebo) sufficient to raise their Breath Alcohol Level (BrAC) to 0.10 g%; the amount of beverage administered is based on their body weight. Those receiving placebo receive the same total quantity of beverage as those receiving alcohol. Both alcohol-dosed and placebo-dosed participants are breath-tested after they have completed their required dose. Participants sleep at the study site and are monitored overnight. The next morning they are awakened and are escorted to the exam room for the performance trials. They return the next week for the second dosing night/dosing morning, and receive either alcohol or placebo, depending on what was administered the previous week, and take different but comparable performance tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol then Placebo | Experimental | Drug: Alcohol, Other: PlaceboParticipants report for their first dosing night where they receive several alcohol drinks. After a wash out period of 1 week they then return and receive several placebo drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials. |
| Placebo then Alcohol | Experimental | Drug: Alcohol, Other: PlaceboParticipants report for their first night where they receive several placebo drinks. After a wash out period of 1 week they then return and receive several alcohol drinks. Participants sleep at the study site, are monitored overnight, and the next morning are awakened and escorted to the performance trials. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Ages 21-30
- Currently enrolled in 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 (16 listed)
- Less than age 21 and greater than age 30
- Not currently enrolled in 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 |
|---|---|---|
| AlcoholAlso: BeerParticipants report for their first dosing night where they receive several alcohol/beer drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. Participants return in a week for the 2nd session and receive placebo drinks. Participants are breath-tested after completing their placebo drinks. | Drug | Alcohol then Placebo, Placebo then Alcohol |
| PlaceboAlso: Non-alcoholic drinkParticipants report for their first night where they receive several placebo drinks. Participants are breath-tested after completing their placebo drinks. Participants return in a week for the 2nd session and receive alcohol drinks sufficient to raise their BrAC to 0.10 g%. Participants are breath-tested after completing their required dose. | Other | Alcohol then Placebo, Placebo then Alcohol |
Primary outcome
Self-reported Residual Effects of Heavy Drinking
Time frame: next day
This outcome will be measured by the afternoon total mood disturbance score. This is part of the Profile of Mood States Questionnaire (POMS). POMS is a 35 item instrument with Likert responses from 0 to 4 where 0=not at all and 4=extremely. Range of scores can be 0 to 140, lower scores are more favorable.
4 secondary outcomes
Cognitive Function in Response to Heavy Drinking
Time frame: next day
Academic Function in Response to Heavy Drinking
Time frame: next day
Reaction Time Affected by Residual Effects of Heavy Drinking
Time frame: next day
Effectiveness of Psychomotor Vigilance Testing as a Fitness-for-duty Test
Time frame: next day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21859168Rohsenow DJ, Howland J, Winter M, Bliss CA, Littlefield CA, Heeren TC, Calise TV. Hangover sensitivity after controlled alcohol administration as predictor of post-college drinking. J Abnorm Psychol. 2012 Feb;121(1):270-5. doi: 10.1037/a0024706. Epub 2011 Aug 22.
- Individual participant dataSharing planned: No
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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 Alcohol in people with Alcoholic Intoxication and Neurobehavioral Manifestations, run by Boston University 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 14 inclusion and 16 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 8 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Residual Effects of Heavy Drinking (time frame: next day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00183170, 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 8 Dec 2020.