Sex Differences in the Response to Abstinence From Alcohol.
Key facts
- Who runs it
- Indiana University
- Where
- Indianapolis, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 160 people, planned
- Started
- 10 Apr 2019
- Expected to end
- 28 Feb 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- Abstinence from alcohol
- Usual drinking
- Intravenous Alcohol
- Record updated
- 12 November 2026
Who can take part
- Age
- 21 years to 35 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Medications (past 30 days) that could influence data or participant safety (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by investigators
- 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
- DSM 5 Disorders (non AUD) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness
- Any condition for which the principal investigators determine it is unsafe or not prudent to enroll
- 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
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 35 years old?
Where in United States
- University HospitalIndianapolis, United StatesContact: Study RecruiterTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Free access alcohol self-administrationTreatment being tested
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
Treatment: Abstinence from alcohol, Usual drinking, and Intravenous Alcohol
- Clamped alcohol exposureTreatment being tested
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.
Treatment: Abstinence from alcohol, Usual drinking, and Intravenous Alcohol
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT03827460, who can take part
- Record updated
- 12 November 2026