Sex Differences in the Response to Abstinence From Alcohol.

NCT03827460 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-15

No results posted yet for this study

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

Interventions

BEHAVIORAL

Abstinence from alcohol

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

BEHAVIORAL

Usual drinking

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

DRUG

Intravenous Alcohol

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Indiana University

    lead OTHER

Principal Investigators

  • Martin H Plawecki, MD, PhD · Psychiatry, Indiana University School of Medicine

  • Melissa A Cyders, PhD · Psychology, Indiana University-Purdue University at Indianapolis

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2026-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03827460 on ClinicalTrials.gov