Sex Differences in the Response to Abstinence From Alcohol.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Abstinence from alcohol, Usual drinking, Intravenous Alcohol.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder. Basic parameters: 21 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 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..
Interventions
- Behavioral Abstinence from alcohol
Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol - Behavioral Usual drinking
Participants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior - Drug Intravenous Alcohol
During the laboratory alcohol infusion sessions, alcohol is infused through an indwelling catheter.
Primary outcome measures
- Sex differences in the effect of abstinence on alcohol self-administration. [Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence]
- Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol. [Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence]
- Sex differences in the effect of abstinence on subjective responses to alcohol. [Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence]
- The role of changes in alcohol elimination on sex differences in response to abstinence. [Time frame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence]
Secondary outcome measures (1)
- Response to abstinence as a predictor of alcohol risk in women and men. [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University Hospital — Indianapolis
Identifiers
NCT: NCT03827460 · 1809467722 · R01AA027236-05