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.
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.
United States2 sites, 2 recruiting
- 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
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.
- Conditions
- Alcohol Use Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Alcohol, Then Placebo, then Free-access session | Experimental | participants 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 session | Experimental | participants 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.
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
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
Change in Breath Alcohol Concentration (BrAC)
Highest BrAC in mg% taken by breathalyzer during the free-access period
Measured: 60 minutes
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
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.
- First posted3 Jul 2023
- Study start1 Apr 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica Weafer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Jessica Weafer, Ohio State University
- Investigators
- Jessica Weafer, PhD, Principal investigator, Ohio State University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Impulsivity Domains and Subjective Response to Alcohol in Young Adults Using Lab and Daily Assessment Methods
- ClinicalTrials.gov ID
- NCT05929677
- Acronym / sponsor ID
- 71127
- Conditions
- Alcohol Use Disorder
- Keywords
- Addiction, Alcohol, Young adult, Impulsivity, Prevention, Subjective response
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Jessica WeaferUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 3 Jul 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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol, Then Placebo, then Free-access session | Experimental | Drug: Placebo, Drug: Alcoholparticipants 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 |
| Placebo, Then Alcohol, then Free-access session | Experimental | Drug: Placebo, Drug: Alcoholparticipants 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 |
Who may qualify
- Ages
- 21 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| PlaceboAlso: SalineParticipants 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. | Drug | Alcohol, Then Placebo, then Free-access session, Placebo, Then Alcohol, then Free-access session |
| AlcoholParticipants 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. | Drug | Alcohol, Then Placebo, then Free-access session, Placebo, Then Alcohol, then Free-access session |
Primary outcome
Lab Subjective Response to Alcohol (SR)
Time frame: 70 minutes
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).
Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR)
Time frame: 10 days
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.
Change in Breath Alcohol Concentration (BrAC)
Time frame: 60 minutes
Highest BrAC in mg% taken by breathalyzer during the free-access period
Number of alcohol drink units self administered
Time frame: 60 minutes
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.
Number of drinks per day
Time frame: 10 days
Participants will report the number of drinks they consume each day via EMA app added to their phone.
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 22 May 2026.
- 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.
Jessica Weafer, PhD principal investigator
Ohio State University
2 sites 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 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.