NCT03827460

Sex Differences in the Response to Abstinence From Alcohol.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 21 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Women and men differ in how quickly they progress from social to problematic alcohol drinking. In laboratory animals, short-term abstinence increases alcohol consumption, with repeated deprivations leading to disordered drinking. In a preliminary study, the investigators found that men and women differed in how their motivation to drink alcohol changed after a short period of abstinence. The investigators hypothesize that this difference may affect their transition to alcohol use disorders. The objectives of this application are to characterize the human post abstinence response, and use identical alcohol exposures to study the mechanisms underlying identified sex differences. In addition, the investigators will complete a 2 year prospective study of natural drinking patterns to assess how self-reported abstinence intervals influence drinking trajectories. The long-term goal of this project is to inform alcohol use disorder treatment and to design and test novel interventions using the laboratory model of post-abstinence response. There is a critical unfilled need to understand sex differences in disease progression, and this lab-based assessment coupled to longitudinal follow-up provides the rigorous experimental design to begin to meet that need. This project will increase scientific knowledge by advancing the translation between preclinical and clinical models, eventually informing sex-specific intervention and prevention strategies for problematic drinking and establishing a model to test those interventions..

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-10
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2019-02-01
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study