Alcohol DrinkingEarly Phase 1(DARC)NCT03930446
Alcohol, Behavior, and Brain Imaging
A Early Phase 1 study testing Ethanol in people with Alcohol Drinking and Binge Drinking, run by University of Chicago.
Trial summary
To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward. 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, Binge Drinking, Drinking Behavior
- What is being tested?
- Ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 May 2019
- Phase
- Early Phase 1
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-29 years old
- 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)
- At least one binge episode (4 for females/5 for males) per month
- No 'flushing' reaction to alcohol
- Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation)
- BMI 19-26
Show all 16Show fewer
- High school education or greater, fluent in English
- No night shift work
- No current or past year Axis I psychiatric disorder including drug/alcohol dependence
- No current psychopharmacological treatment
- No lifetime ADHD or prescription for ADHD medication
- No abnormal EKG, cardiovascular illness, high blood pressure
- No medical condition or pharmacological treatment for which alcohol is contraindicated
- Not pregnant, lactating, or planning to become pregnant
- Smoke <6 cigarettes per day
- No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM
Who cannot join
None listed.
About this study
To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.
- Conditions
- Alcohol Drinking, Binge Drinking, Drinking Behavior, Substance-Related Disorders, Ethanol, Physiological Effects of Drugs
- Being tested
- Ethanol, Placebo
- Medical subject headings
- Alcohol Drinking, Binge Drinking, Drinking Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EthanolDrug
The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
PlaceboOther
The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
| Study group | Role | What they receive |
|---|---|---|
| Ethanol | Experimental | Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg). Receives: Drug: Ethanol |
| Placebo (Juice) | Placebo comparator | Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stop Signal Task (SST)
The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
Measured: Within an hour post-stimulation condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Jan 2016
- Primary completion30 May 2019
- Study completion30 May 2019
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Weafer, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930446
- Sponsor's protocol ID
- IRB16-0015
- Acronym
- (DARC)
- Status last verified
- Feb 2022
- First submitted
- 25 Apr 2019
- Last updated
- 25 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Murray CH, Weafer J, de Wit H. Subjective Effects of Alcohol Predict Alcohol Choice in Social Drinkers. Alcohol Clin Exp Res. 2020 Dec;44(12):2579-2587. doi: 10.1111/acer.14476. Epub 2020 Nov 17.
PubMed 33201577
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol, Behavior, and Brain Imaging
- ClinicalTrials.gov ID
- NCT03930446
- Acronym / sponsor ID
- (DARC) / IRB16-0015
- Conditions
- Alcohol Drinking, Binge Drinking, Drinking Behavior, Substance-Related Disorders, Ethanol, Physiological Effects of Drugs
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 25 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethanol | Experimental | Drug: EthanolSubjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg). |
| Placebo (Juice) | Placebo comparator | Other: PlaceboSubjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice). |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 21-29 years old
- 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)
- At least one binge episode (4 for females/5 for males) per month
- No 'flushing' reaction to alcohol
- Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EthanolThe 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water | Drug | Ethanol |
| PlaceboThe placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent. | Other | Placebo (Juice) |
Primary outcome
Stop Signal Task (SST)
Time frame: Within an hour post-stimulation condition
The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33201577Li J, Murray CH, Weafer J, de Wit H. Subjective Effects of Alcohol Predict Alcohol Choice in Social Drinkers. Alcohol Clin Exp Res. 2020 Dec;44(12):2579-2587. doi: 10.1111/acer.14476. Epub 2020 Nov 17.
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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.
Jessica Weafer principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ethanol in people with Alcohol Drinking and Binge Drinking, run by University of Chicago.
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 16 inclusion and 0 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 25 Apr 2022). 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?
Stop Signal Task (SST) (time frame: Within an hour post-stimulation condition). 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 NCT03930446, 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 25 Apr 2022.