University Hospital
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
NCT Number: NCT03827460
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.
Interested in participating?
Request Info21 year–35 year
All sexes
Interventional
Phase 1
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
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 leading to disordered drinking. In a preliminary study, the investigators found that men and women differed in how their motivation to drink alcohol changed after a short period of abstinence. The investigators hypothesize that this difference may affect their transition to alcohol use disorders. The objectives of this application are to characterize the human post abstinence response, and use identical alcohol exposures to study the mechanisms underlying identified sex differences. In addition, the investigators will complete a 2 year prospective study of natural drinking patterns to assess how self-reported abstinence intervals influence drinking trajectories. The long-term goal of this project is to inform alcohol use disorder treatment and to design and test novel interventions using the laboratory model of post-abstinence response. There is a critical unfilled need to understand sex differences in disease progression, and this lab-based assessment coupled to longitudinal follow-up provides the rigorous experimental design to begin to meet that need. This project will increase scientific knowledge by advancing the translation between preclinical and clinical models, eventually informing sex-specific intervention and prevention strategies for problematic drinking and establishing a model to test those interventions..
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 6.0& (v/V) ethanol solution
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
The effect of 2 weeks abstinence on intravenous alcohol intake will be compared in men and women.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
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.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
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.
Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol 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.
Time frame: 2 years
For both Arm 1 and Arm 2, daily alcohol consumption will be surveyed every 2 months for 2 years following the laboratory sessions. Self-imposed periods of abstinence will be assessed to determine if subsequent daily alcohol intake increases or decreases, and to determine if men and women differ in the effect of abstinence on drinking.
Interested in participating?
Request InfoIndiana University
Other
Acronym: SPAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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