Alcohol DrinkingEarly Phase 1NCT03467191
Behavioral Alcohol Responses (BAR) Study
A Early Phase 1 study testing Alcohol in people with Alcohol Drinking and Alcohol Use Disorder, run by Carnegie Mellon University at 1 site in United States.
Trial summary
This study aims to identify risk factors that prospectively predict alcohol problems in young adults. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication
- What is being tested?
- Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 782 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2018to 31 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21 to 29 years of age
- currently drinks alcohol
- owns a smartphone
Who cannot join
- [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Trial locations and contacts
1 site in 1 country.
United States1 site
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting
This study aims to identify risk factors that prospectively predict alcohol problems in young adults.
Read the detailed description
The vast majority of alcohol use takes place in social settings, yet nearly all human experimental work has administered alcohol to individuals in isolation. This study will examine the effects of alcohol in social groups and test whether these responses predict the escalation of alcohol use and development of alcohol use disorder symptoms. Participants will also complete smartphone surveys querying subjective responses to alcohol in their daily lives.
N=400 male and female young adults will participate in a laboratory session with two other participants and will consume either a moderate dose of alcohol or placebo beverage. Subjective and objective responses to alcohol will be assessed. Participants will also complete surveys on their smartphones; these will occur during drinking episodes and at random times throughout the day. Follow-up sessions will occur at 6-months and 12-months, to collect information about drinking habits and potential alcohol-related problems.
- Conditions
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
- Being tested
- Alcohol, Placebo
- Medical subject headings
- Alcohol Drinking, Alcoholism, Alcoholic Intoxication, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
target BAC .08%
PlaceboOther
placebo beverage
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Beverage | Experimental | Moderate dose of alcohol (target BAC .08%) Receives: Drug: Alcohol |
| Placebo Beverage | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Alcohol Use at 12-months
Timeline Follow Back Method
Measured: 12-month follow-up
Change from Baseline Alcohol Use Disorder Symptoms at 12-months
Structured Clinical Interview for DSM-5
Measured: 12-month follow-up
Secondary outcomes (5)
Subjective Responses to Alcohol
Participants will indicate how they feel after drinking alcohol using the Brief-Biphasic Alcohol Effects Scale, which is a 6-item scale assessing alcohol's acute stimulant and sedative effects (0-10 scale, with higher scores indicating higher values).
Measured: 1 day (laboratory session) and 21-day ambulatory assessment period
Social Bonding
Facial expressions of emotions using Paul Ekman's Facial Action Coding System (FACS). The duration of AUs associated with positive and negative affect will be coded.
Measured: 1 day (laboratory session)
Social Bonding
Perceived Group Reinforcement Scale, which is a 12-item scale assessing self-reported bonding (1-9 scale, with higher scores indicating more bonding).
Measured: 1 day (laboratory session)
Mood
8-item Mood Measure, which is an 8-item scale assessing mood items from each of the four quadrants of the affective circumplex (with higher scores indicating more felt emotion).
Measured: 1 day (laboratory session)
Alcohol Use
Quantity of standard drinks consumed.
Measured: 21-day ambulatory assessment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start13 Feb 2018
- Primary completion15 Jul 2022
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carnegie Mellon University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
- Responsible party
- Principal investigator, Kasey Creswell, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467191
- Sponsor's protocol ID
- STUDY2017_00000346
- Other IDs
- R01AA025936
- Status last verified
- Feb 2025
- First submitted
- 1 Mar 2018
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting
- ClinicalTrials.gov ID
- NCT03467191
- Acronym / sponsor ID
- STUDY2017_00000346
- Conditions
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Carnegie Mellon UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 15 Mar 2018 (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.
This study aims to identify risk factors that prospectively predict alcohol problems in young adults.
Detailed description
The vast majority of alcohol use takes place in social settings, yet nearly all human experimental work has administered alcohol to individuals in isolation. This study will examine the effects of alcohol in social groups and test whether these responses predict the escalation of alcohol use and development of alcohol use disorder symptoms. Participants will also complete smartphone surveys querying subjective responses to alcohol in their daily lives.
N=400 male and female young adults will participate in a laboratory session with two other participants and will consume either a moderate dose of alcohol or placebo beverage. Subjective and objective responses to alcohol will be assessed. Participants will also complete surveys on their smartphones; these will occur during drinking episodes and at random times throughout the day. Follow-up sessions will occur at 6-months and 12-months, to collect information about drinking habits and potential alcohol-related problems.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Beverage | Experimental | Drug: AlcoholModerate dose of alcohol (target BAC .08%) |
| Placebo Beverage | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21 to 29 years of age
- currently drinks alcohol
- owns a smartphone
Key exclusion criteria (1 listed)
- [Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
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 |
|---|---|---|
| Alcoholtarget BAC .08% | Drug | Alcohol Beverage |
| Placeboplacebo beverage | Other | Placebo Beverage |
Primary outcome
Change from Baseline Alcohol Use at 12-months
Time frame: 12-month follow-up
Timeline Follow Back Method
Change from Baseline Alcohol Use Disorder Symptoms at 12-months
Time frame: 12-month follow-up
Structured Clinical Interview for DSM-5
5 secondary outcomes
Subjective Responses to Alcohol
Time frame: 1 day (laboratory session) and 21-day ambulatory assessment period
Social Bonding
Time frame: 1 day (laboratory session)
Social Bonding
Time frame: 1 day (laboratory session)
Mood
Time frame: 1 day (laboratory session)
Alcohol Use
Time frame: 21-day ambulatory assessment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol in people with Alcohol Drinking and Alcohol Use Disorder, run by Carnegie Mellon 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change from Baseline Alcohol Use at 12-months (time frame: 12-month follow-up). The study lists 2 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 12 Feb 2025.