Sex Differences in the Response to Abstinence from Alcohol (SPAR)
Alcohol Abstinence and Drinking Patterns
Martin Plawecki, MD, PhD
Primary Investigator
Brief description of study
Detailed description of study
The Infusion phase of this study consists of two weeks during which you will agree to not drink any alcohol. On the infusion days, you will have an experiment lasting up to 3 hours during which you will either be allowed to choose how much alcohol you want to infuse, or you will experience a constant, moderate level of intoxication. During the two-week abstinence period, you will wear an alcohol monitoring device on your ankle or provide urine samples to test for alcohol consumption.
The Follow-up phase of the experiment lasts for 2 years, during which you agree to answer a brief online or phone survey about your alcohol use, about every 3 months, and two interviews at the end of year 1 and at the end of year 2. For more information, please see the What Will Happen during the Study section below.
The Infusion phase will last about 3-6 weeks, depending on scheduling of the infusion sessions and abstinence interval, and consist of 2 or 3 full days (up to 12 hours) and from 2-8 short visits to the lab, depending on your schedule and the method of monitoring discussed below. The Follow-up phase will last for 2 years and consist of 6 brief interviews completed online or over the phone (lasting about 15-20 min each) and 2 interviews in the lab or via video conferencing (lasting about 2-3 hours each).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Alcohol use disorder, AUD
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Age: 21 years - 35 years
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Gender: Male
Overtly healthy men
Drink alcohol
Able to understand/complete questionnaires and procedures in English
Have venous access sufficient to allow blood sampling
Pregnant or breast-feeding women
This study investigates how men and women respond to stopping alcohol consumption. It looks at drinking patterns over both short-term and long-term periods. The study aims to understand differences in response between men and women when they stop drinking alcohol.
Participants will go through an Infusion phase where they will not drink alcohol for two weeks. During this time, they will either choose their alcohol intake or experience a set level of intoxication. They will wear a device to monitor alcohol use or provide urine samples. After this, there is a Follow-up phase lasting two years, with periodic surveys and interviews about their drinking habits.
- Who can participate: Healthy men who drink alcohol, can complete procedures in English, and have suitable venous access can participate. Pregnant or breastfeeding women are excluded.
- Study details: Participants will abstain from alcohol for two weeks while being monitored. They will have the choice to control alcohol intake or experience a set level of intoxication during lab visits. Monitoring includes wearing a device or providing urine samples.
- Study timelines: The study will last 2 years.
