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Sex Differences in the Response to Abstinence From Alcohol.

NCT ID: NCT03827460

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-10

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Alcohol Use Disorder

Keywords

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Alcohol Alcoholism Sex Differences Abstinence Alcohol Deprivation Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arms 1 and 2: 2 session parallel, random order, no blind.

Arm 3: Sequential, includes all subjects who complete Arm1 or Arm 2
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

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.

Study Groups

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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

Group Type EXPERIMENTAL

Abstinence from alcohol

Intervention Type BEHAVIORAL

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

Usual drinking

Intervention Type BEHAVIORAL

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

Intravenous Alcohol

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Abstinence from alcohol

Intervention Type BEHAVIORAL

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

Usual drinking

Intervention Type BEHAVIORAL

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

Intravenous Alcohol

Intervention Type DRUG

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

2 year followup

Participants from both Arm 1 and Arm 2 will be surveyed every 2 months for alcohol consumption for 2 years following the Experimental phase. Interventions include Abstinence from Alcohol and Usual Drinking.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Abstinence from alcohol

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

Intervention Type BEHAVIORAL

Usual drinking

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

Intervention Type BEHAVIORAL

Intravenous Alcohol

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

Intervention Type DRUG

Other Intervention Names

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6.0& (v/V) ethanol solution

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Martin Plawecki

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin H Plawecki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychiatry, Indiana University School of Medicine

Melissa A Cyders, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychology, Indiana University-Purdue University at Indianapolis

Locations

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University Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ann E Kosobud, Ph.D.

Role: CONTACT

Phone: (317) 274-0087

Email: [email protected]

Facility Contacts

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Study Recruiter

Role: primary

Other Identifiers

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R01AA027236-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1809467722

Identifier Type: -

Identifier Source: org_study_id