Recruiting
Phase 1

Observational Study

Sponsor:

Indiana University

Code:

NCT03827460

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 35

Healthy Volunteers: Accepted

Interventions

Abstinence from alcohol

Usual drinking

Intravenous Alcohol

Study Details

Brief summary:

In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. In the present study, the investigators propose to study how men and women respond to abstinence, and whether this information can be used to improve intervention and prevention strategies.

Conditions

Alcohol Use Disorder

Study ID

NCT03827460

Start date

Apr 10, 2019

Status verified date

Apr, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Moderate social drinkers
  • Able to understand/complete questionnaires and procedures in English
  • Body mass index (BMI) between 18.5 and 32 kg/m2
  • Have venous access sufficient to allow blood sampling

Exclusion Criteria:

  • Pregnant or breast-feeding women, or women who intend to become pregnant
  • Do not attest to using accepted forms of birth control for the infusion phase of the study
  • Current treatment for, or desire to be treated for, any substance use disorder or court ordered to not drink alcohol
  • History of significant adverse reaction to alcohol
  • Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety
  • Medications (past 30 days) that could influence data or participant safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by investigators
  • DSM 5 Disorders (non AUD) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness
  • Positive breath alcohol reading on arrival at any study visit
  • Actively suicidal (for example, any suicide attempts within the past year or any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the investigator
  • Any condition for which the principal investigators determine it is unsafe or not prudent to enroll

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Free access alcohol self-administration

During the 2.5-hour free-access self-administration sessions, the participant may choose to complete a task for an alcohol or water reward. Interventions include Abstinence from Alcohol and Usual Drinking

experimental: Clamped alcohol exposure

A battery of behavioral tasks will be administered to participants before, and at the beginning and end of a 3 hour clamped exposure to alcohol (fixed at 80 mg/dL). EEG will be recorded throughout to assess event related potentials associated with task performance. Interventions include Abstinence from Alcohol and Usual Drinking.

Interventions

Abstinence from alcohol

Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol

Usual drinking

Participants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior

Intravenous Alcohol

During the laboratory alcohol infusion sessions, alcohol is infused through an indwelling catheter.

Primary outcome measure

  • Sex differences in the effect of abstinence on alcohol self-administration. [ Time Frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence ]
  • Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol. [ Time Frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence ]
  • Sex differences in the effect of abstinence on subjective responses to alcohol. [ Time Frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence ]
  • The role of changes in alcohol elimination on sex differences in response to abstinence. [ Time Frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence ]

Central Contacts and Locations

Central contacts

Ann E Kosobud, Ph.D.

(317) 274-0087akosobud@iupui.edu

Locations

University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Study Recruiter

317-948-6551erptest@iupui.edu

Principal Investigator:

Martin H Plawecki, MD, PhD

More Information

Sponsor

Indiana University

Last update posted

May 15, 2026

Last verified

Apr, 2026

Keywords

  • Alcohol
  • Alcoholism
  • Sex Differences
  • Abstinence
  • Alcohol Deprivation Effect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-15.