Recruiting
Early Phase 1

Observational Study

Sponsor:

Jessica Weafer

Code:

NCT05929677

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 25

Healthy Volunteers: Accepted

Interventions

Placebo

Alcohol

Study Details

Brief 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. 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.

Conditions

Alcohol Use Disorder

Study ID

NCT05929677

Start date

Apr 1, 2024

Status verified date

May, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Alcohol, Then Placebo, then Free-access session

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

experimental: Placebo, Then Alcohol, then Free-access session

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

Interventions

Placebo

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.

Alcohol

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.

Primary outcome measure

  • Lab Subjective Response to Alcohol (SR) [ Time Frame: 70 minutes ]
  • Ecological Momentary Assessment (EMA) Subjective Response to Alcohol (SR) [ Time Frame: 10 days ]
  • Change in Breath Alcohol Concentration (BrAC) [ Time Frame: 60 minutes ]
  • Number of alcohol drink units self administered [ Time Frame: 60 minutes ]
  • Number of drinks per day [ Time Frame: 10 days ]

Central Contacts and Locations

Central contacts

Jessica Weafer, PhD

614-257-2075jessica.weafer@osumc.edu

Locations

Northeastern University

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Robert Leeman

617-373-6501r.leeman@northeastern.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Jessica Weafer, PhD

614-257-2075jessica.weafer@osumc.edu

More Information

Sponsor

Jessica Weafer

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Addiction
  • Alcohol
  • Young adult
  • Impulsivity
  • Prevention
  • Subjective response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jessica Weafer on 2026-05-22.