Status:
RECRUITING
Sex Differences in the Response to Abstinence From Alcohol.
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-35 years
Phase:
PHASE1
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 invest...
Detailed 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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03827460
Start Date
April 10 2019
End Date
August 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
University Hospital
Indianapolis, Indiana, United States, 46202