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Understanding Sex Differences in Alcohol Abstinence Response

This study is looking at how men and women respond differently after a period of not drinking alcohol. Researchers want to understand if taking a break from alcohol, called abstinence, affects men and women's desire to drink alcohol differently. You would participate in two laboratory sessions where you receive intravenous alcohol (alcohol given through a vein). One session follows two weeks of not drinking alcohol, and the other is during your usual drinking habits. The goal is to learn how these differences might help improve ways to prevent and treat alcohol use disorder. The study plans to enroll 160 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 160 participants. It compares two behavioral interventions: abstinence from alcohol and usual drinking, both involving intravenous alcohol.
What's involved
You would participate in two single-day laboratory sessions. One session follows two weeks of monitored abstinence from alcohol, and the other is during a period of your usual drinking behavior.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at two single-day laboratory sessions. The study also includes a two-year prospective study of natural drinking patterns.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03827460

Sex Differences in the Response to Abstinence From Alcohol.

Recruiting
PHASE1Ages 21–35InterventionalBasic science
Indiana University
~160 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Abstinence from alcoholUsual drinkingIntravenous Alcohol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sex differences in the effect of abstinence on alcohol self-administration.
Measured over 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
+3 more outcomes measured

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Martin H Plawecki, MD, PhD · PRINCIPAL_INVESTIGATOR · Psychiatry, Indiana University School of Medicine
  • Melissa A Cyders, PhD · PRINCIPAL_INVESTIGATOR · Psychology, Indiana University-Purdue University at Indianapolis

Who to contact

Ann E Kosobud, Ph.D.
[email protected]
(317) 274-0087
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sex differences in the effect of abstinence on alcohol self-administration.2 single day laboratory sessions, one following 2 weeks alcohol abstinence

    The effect of 2 weeks abstinence on intravenous alcohol intake will be compared in men and women.

  • Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.2 single day laboratory sessions, one following 2 weeks alcohol abstinence

    The effect of 2 weeks abstinence from alcohol on sensitivity of the neurophysiological P3 response to alcohol, assessed using a stop-signal response task, will be compared in women and men during an iv infusion clamp.

  • Sex differences in the effect of abstinence on subjective responses to alcohol.2 single day laboratory sessions, one following 2 weeks alcohol abstinence

    The effect of 2 weeks abstinence from alcohol on subjective responses to alcohol in women and men will be assessed using a survey during an iv infusion clamp.

  • The role of changes in alcohol elimination on sex differences in response to abstinence.2 single day laboratory sessions, one following 2 weeks alcohol abstinence

    The effect of 2 weeks abstinence from alcohol on alcohol elimination in men and women will be assessed using an iv alcohol infusion clamp.