Sex Differences in the Response to Abstinence From Alcohol.
SPAR
2 other identifiers
interventional
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
April 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
May 15, 2026
April 1, 2026
7.4 years
November 12, 2018
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Sex differences in the effect of abstinence on alcohol self-administration.
The effect of 2 weeks abstinence on intravenous alcohol intake will be compared in men and women.
2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.
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.
2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Sex differences in the effect of abstinence on subjective responses to alcohol.
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.
2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The role of changes in alcohol elimination on sex differences in response to 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.
2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Secondary Outcomes (1)
Response to abstinence as a predictor of alcohol risk in women and men.
2 years
Study Arms (2)
Free access alcohol self-administration
EXPERIMENTALDuring 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
Clamped alcohol exposure
EXPERIMENTALA 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.
Interventions
Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol
Participants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior
During the laboratory alcohol infusion sessions, alcohol is infused through an indwelling catheter.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
November 12, 2018
First Posted
February 1, 2019
Study Start
April 10, 2019
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2028
Last Updated
May 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After all subjects have been collected and the primary outcomes accepted for publication. The dataset will be available indefinitely,
- Access Criteria
- On request to the PIs
The final raw dataset will be available to other researchers when we have collected all subjects and completed our own planned analyses. Prior to completion of our own planned analyses, we would be willing to consider releasing the dataset upon request. We will work with our IRB to establish a strategy for de-identifying the data while retaining the ability to ensure the quality of the stored data, and develop a data-sharing agreement.