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Alcohol Use DisorderEarly Phase 1NCT05929677

Impulsivity Domains and Subjective Response

A Early Phase 1 study testing Alcohol in people with Alcohol Use Disorder, run by Jessica Weafer at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. Read more about this study

Who is it for?
Ages 21 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Alcohol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
2 sitesUnited States
Study dates
1 Apr 2024to 1 Sep 2027
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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 21-25 years old
  • Report drinking to an estimated BAC > .08% at least once in the past 30 days based on responses on the Timeline Followback (TLFB)
  • Report drinking at least twice weekly in the past 30 days based on responses on the TLFB
  • Fluency in English

Who cannot join

  • Any serious medical problems (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological problems, and gastrointestinal disorders)
  • Body weight < 110 or > 210 pounds
  • Axis I psychiatric disorders including substance use disorder other than mild or moderate alcohol or mild cannabis use disorder
  • Current alcohol withdrawal or history of medically-assisted detoxification
  • Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment or experimental session
  • Positive urine screen for illegal drugs other than cannabis
Show all 11Show fewer
  • Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
  • Current psychotropic medication use or receipt of a prescription for these medications in the past 30 days
  • Psychosis or other psychiatric disability
  • Pregnancy, nursing or lack of reliable birth control use for women
  • Report smoking > 5 cigarettes per day (to avoid acute nicotine effects or withdrawal during experimental sessions)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jessica Weafer, PhD contact

614-257-2075

jessica.weafer@osumc.edu

United States2 sites, 2 recruiting
  • Northeastern University

    Boston, Massachusetts, 02115

    Robert Leeman, 617-373-6501, r.leeman@northeastern.edu

    Recruiting
  • Ohio State University

    Columbus, Ohio, 43221

    Jessica Weafer, PhD, 614-257-2075, jessica.weafer@osumc.edu

    Recruiting

Other trials in United States

About this study

Official title: Linking Impulsivity Domains and Subjective Response to Alcohol in Young Adults Using Lab and Daily Assessment Methods

Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults.

Read the detailed description

Young adult alcohol misuse is an urgent, growing public health crisis, as young adults have the highest alcohol use disorder rates of any age group with rates increasing in young women. Interventions for this population are hampered by small effects, few options and lack of tailoring to salient risk factors. A recent review in Addiction argued that research informing interventions fails to account for the complexity of relationships among factors contributing to young adult alcohol misuse. These needs will be addressed by examining relationships between two cardinal etiologic risk factors: impulsivity and subjective response to alcohol (SR). Despite theoretical and biological links between them, little is known about relations between the two risk factors, or how associations between them may promote young adult alcohol misuse longitudinally and on a momentary or daily basis. Prior theory and evidence linking impulsivity and positive, rewarding alcohol effects have been primarily learning and expectancy based. Here, based on exciting preliminary results, the researchers posit an inherent, biological link between impulsivity and high-risk SR (elevated stimulation and dampened sedation). This research is nascent with multiple gaps in knowledge. These gaps will be addressed by examining impulsivity pre-drinking, SR and alcohol use in a lab setting and via seven 10-day daily assessment periods over 2 years using ecological momentary assessment (EMA) (N=250, 50% female). Using self-report and both lab and mobile tasks, the investigators will characterize 3 unique, established impulsivity domains: poor inhibitory control, delay discounting and negative urgency. SR will be assessed at successive breath alcohol levels using precision intravenous (IV) methods in the lab, followed by opportunity to self-administer more IV alcohol. SR will also be measured at roughly comparable, estimated blood alcohol levels via daily EMA methods. This design enables testing of SR early in a drinking event as a predictor of in-lab and daily alcohol use, along with alcohol use and consequences over time, plus SR's potential role as a mediator of impulsivity/alcohol relations. Recent findings indicate daily changes in impulsivity predict subsequent drinking and consequences. These types of changes are challenging to capture with lab methods only. Daily measures also enable modeling of both person-level individual differences and daily, within-subject effects. However, there are no published studies relating daily impulsivity and SR measures. In this study, investigators will: 1) determine relations between lab-based impulsivity and SR; 2) determine relations between daily impulsivity and SR; and 3) relate impulsivity and SR to alcohol misuse longitudinally.

Researchers hypothesize impulsivity will relate to heightened stimulation and less sedation following alcohol and that SR will partially mediate relations between impulsivity and alcohol misuse. Evidence of links between specific impulsivity domains and SR longitudinally and on a momentary/daily basis will point to specific intervention targets to ameliorate two critical vulnerability factors for young adult alcohol misuse. Thus, investigators will: 1) identify mechanisms of alcohol action and 2) facilitate prevention and treatment research: two NIAAA priority areas.

Findings from this project will determine the relationship between two vulnerability factors for Alcohol Use Disorder (AUD) in young adults: impulsivity and subjective response to alcohol. The results will identify badly needed, novel targets for prevention and treatment efforts to simultaneously reduce impulsivity and subjective responses in at-risk young adults. As such, the project is directly relevant to NIAAA's mission to identify mechanisms of alcohol action and facilitate prevention and treatment research.

Being tested
Placebo, Alcohol
Keywords
Addiction, Alcohol, Young adult, Impulsivity, Prevention, Subjective response
Medical subject headings
Alcoholism, Behavior, Addictive, Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Saline

    Participants receive placebo (saline) intravenously. They will also have the opportunity to self-administer saline during the 60-minute free-access IV self-administration period in session 3.

  • AlcoholDrug

    Participants receive alcohol intravenously, clamped at BrACs of 20mg%, 40mg%, and 60mg%. They will also have the opportunity to self-administer alcohol (up to 120mg% BrAC) during the 60-minute free-access IV self-administration period in session 3.

Study groups in NCT05929677
Study groupRoleWhat they receive
Alcohol, Then Placebo, then Free-access sessionExperimentalparticipants will complete two intravenous administration sessions in the lab during which they will receive alcohol then placebo (saline), followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min
Receives: Drug: Placebo; Drug: Alcohol
Placebo, Then Alcohol, then Free-access sessionExperimentalparticipants will complete two intravenous administration sessions in the lab during which they will receive placebo (saline) then alcohol, followed by a third lab session in which they will have free-access to self-administer alcohol (up to 120mg% BrAC) and placebo intravenously for 60 min
Receives: Drug: Placebo; Drug: Alcohol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lab Subjective Response to Alcohol (SR)

    Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation).

    Measured: 70 minutes

  2. Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)

    Participants provide subjective ratings of stimulation and sedation using the Brief Biphasic Alcohol Effects Scale (scores from 0 to 10 where a higher number means more stimulation/sedation) using the EMA app.

    Measured: 10 days

  3. Change in Breath Alcohol Concentration (BrAC)

    Highest BrAC in mg% taken by breathalyzer during the free-access period

    Measured: 60 minutes

  4. Number of alcohol drink units self administered

    participants can self-administer alcohol infusions by pushing 1 of 2 buttons to receive an alcohol or water "drink" unit. Each alcohol "drink" targets a 7.5mg% increase in BrAC over 2.5 min. The water "drink" is an equal volume of saline.

    Measured: 60 minutes

  5. Number of drinks per day

    Participants will report the number of drinks they consume each day via EMA app added to their phone.

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start1 Apr 2024
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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, Investigator
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05929677
Sponsor's protocol ID
71127
Other IDs
R01AA029488
Status last verified
May 2026
First submitted
19 May 2023
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Alcohol in people with Alcohol Use Disorder, run by Jessica Weafer at 2 sites 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 11 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Contact Jessica Weafer, PhD (614-257-2075, jessica.weafer@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lab Subjective Response to Alcohol (SR) (time frame: 70 minutes). The study lists 5 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 22 May 2026.

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Impulsivity Domains and Subjective Response | AzTrials