Sex Differences in the Response to Abstinence From Alcohol.

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT03827460
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Abstinence from alcohol — BEHAVIORAL
    Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol
  • Usual drinking — BEHAVIORAL
    Participants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior
  • Intravenous Alcohol — DRUG
    During the laboratory alcohol infusion sessions, alcohol is infused through an indwelling catheter.

Study Details

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.

Key Dates

Start date
Apr 10, 2019
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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
  • Experimental: 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.

Primary Outcome Measure

Sex differences in the effect of abstinence on alcohol self-administration. [ Time Frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University HospitalIndianapolisIndiana46202
Study Recruiter
[email protected]
317-948-6551
Martin H Plawecki, MD, PhD (PRINCIPAL_INVESTIGATOR)
Melissa A Cyders, PhD (PRINCIPAL_INVESTIGATOR)
Wei Wu, PhD (SUB_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By condition
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By specialty
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By research site
University Hospital· Indianapolis, IN

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