Alcohol DrinkingEarly Phase 1SEANCT05826951
Social Effects of Alcohol
A Early Phase 1 study testing Alcohol in people with Alcohol Drinking, run by University of Chicago at 1 site in United States.
Trial summary
In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 3 Oct 2023
- Phase
- Early Phase 1
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-problem alcohol consumption of 2-20 drinks per week
- high school diploma or equivalent
- BMI between 19 and 26
- verbal fluency in English
Who cannot join
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Women who are pregnant or trying to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction
Read the detailed description
The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.
- Conditions
- Alcohol Drinking
- Being tested
- Alcohol, Placebo
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Alcohol (0.8g/kg)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-alcohol | Experimental | Both conversation partners receive alcohol Receives: Drug: Alcohol |
| placebo-placebo | Placebo comparator | Both conversation partners receive placebo Receives: Drug: Placebo |
| alcohol-placebo | Experimental | participant receives alcohol and conversation partner receives placebo Receives: Drug: Alcohol |
| placebo-alcohol | Experimental | participant receives placebo and conversation partner receives alcohol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial emotional responses
alterations in the rate of positive facial expressions during the conversation, measured by muscle action units. These will be compared between the drug and placebo sessions
Measured: during the length of the conversation (45 min)
self-reported feelings of connection
self-other overlap measure ratings 1-7, greater ratings indicates greater feelings of connection
Measured: at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start20 Feb 2023
- Primary completion3 Oct 2023
- Study completion3 Oct 2023
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.
- More trials run by University of ChicagoThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Harriet de Wit, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826951
- Sponsor's protocol ID
- IRB22-1696
- Other IDs
- 5R01DA002812-35
- Acronym
- SEA
- Status last verified
- Jan 2024
- First submitted
- 30 Mar 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Effects of Alcohol
- ClinicalTrials.gov ID
- NCT05826951
- Acronym / sponsor ID
- SEA / IRB22-1696
- Conditions
- Alcohol Drinking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 3 Oct 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 24 Apr 2023 (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.
In this study the investigator will assess the effect of a moderate dose of alcohol on emotional responses and feelings of connection during a dyadic semi-structured social interaction
Detailed description
The study will use a within-subject crossover design with four sessions, in which participants receive alcohol or placebo across sessions. During the four sessions, the participants will engage in a conversation with a stranger, and emotional responses and feelings of connection will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol-alcohol | Experimental | Drug: AlcoholBoth conversation partners receive alcohol |
| placebo-placebo | Placebo comparator | Drug: PlaceboBoth conversation partners receive placebo |
| alcohol-placebo | Experimental | Drug: Alcoholparticipant receives alcohol and conversation partner receives placebo |
| placebo-alcohol | Experimental | Drug: Placeboparticipant receives placebo and conversation partner receives alcohol |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non-problem alcohol consumption of 2-20 drinks per week
- high school diploma or equivalent
- BMI between 19 and 26
- verbal fluency in English
Key exclusion criteria (4 listed)
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Women who are pregnant or trying to become pregnant.
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 |
|---|---|---|
| AlcoholAlcohol (0.8g/kg) | Drug | Alcohol-alcohol, alcohol-placebo |
| PlaceboPlacebo | Drug | placebo-alcohol, placebo-placebo |
Primary outcome
facial emotional responses
Time frame: during the length of the conversation (45 min)
alterations in the rate of positive facial expressions during the conversation, measured by muscle action units. These will be compared between the drug and placebo sessions
self-reported feelings of connection
Time frame: at the end of each session (3.5 hrs post-drug administration). Changes across sessions will be assessed
self-other overlap measure ratings 1-7, greater ratings indicates greater feelings of connection
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 24 Jan 2024.
Related trials for Alcohol Drinking
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Harriet de Wit principal investigator
University of Chicago
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, run by University of Chicago 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 4 inclusion and 4 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 24 Jan 2024. 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?
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?
facial emotional responses (time frame: during the length of the conversation (45 min)). 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 24 Jan 2024.