NCT05929677

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for early_phase_1

Timeline
16mo left

Started Apr 2024

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Apr 2024Sep 2027

First Submitted

Initial submission to the registry

May 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

May 19, 2023

Last Update Submit

February 3, 2026

Conditions

Alcohol Use Disorder

Keywords

AddictionAlcoholYoung adultImpulsivityPreventionSubjective response

Outcome Measures

Primary Outcomes (5)

  • 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).

    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.

    10 days

  • Change in Breath Alcohol Concentration (BrAC)

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

    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.

    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.

    10 days

Study Arms (2)

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

Drug: PlaceboDrug: 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

Drug: PlaceboDrug: Alcohol

Interventions

PlaceboDRUG

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.

Also known as: Saline
Alcohol, Then Placebo, then Free-access sessionPlacebo, Then Alcohol, then Free-access session
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.

Alcohol, Then Placebo, then Free-access sessionPlacebo, Then Alcohol, then Free-access session

Eligibility Criteria

Age21 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismBehavior, AddictiveImpulsive Behavior

Interventions

Sodium ChlorideEthanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAlcoholsOrganic Chemicals

Study Officials

  • Jessica Weafer, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Weafer, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2023

First Posted

July 3, 2023

Study Start

April 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)