Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Alcohol Use Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arms 1 and 2: 2 session parallel, random order, no blind. Arm 3: Sequential, includes all subjects who complete Arm1 or Arm 2Masking: None (Open Label)Masking Description: The intervention is 2 weeks of monitored abstinence from alcohol compared to usual drinking. Thus, it is not possible to mask conditions for participants or investigators.Primary Purpose: Basic Science

Participation Requirements

Age
Between 21 years and 35 years
Gender
Both males and females

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 dif...

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..

Tracking Information

NCT #
NCT03827460
Collaborators
Not Provided
Investigators
Principal Investigator: Martin H Plawecki, MD, PhD Psychiatry, Indiana University School of Medicine Principal Investigator: Melissa A Cyders, PhD Psychology, Indiana University-Purdue University at Indianapolis