Clinical trial NCT03827460: Sex Differences in the Response to Abstinence From Alcohol.
Official title: Sex Differences in the Response to Abstinence From Alcohol.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Alcohol Use Disorder
Keywords: Alcohol
Alcoholism
Sex Differences
Abstinence
Alcohol Deprivation Effect
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-02-01
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arms 1 and 2: 2 session parallel, random order, no blind.

Arm 3: Sequential, includes all subjects who complete Arm1 or Arm 2
Primary purpose: BASIC_SCIENCE

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 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..

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

Primary outcomes:
measure: Sex differences in the effect of abstinence on alcohol self-administration.
timeFrame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
measure: Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.
timeFrame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
measure: Sex differences in the effect of abstinence on subjective responses to alcohol.
timeFrame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
measure: The role of changes in alcohol elimination on sex differences in response to abstinence.
timeFrame: 2 single day laboratory sessions, one following 2 weeks alcohol abstinence
measure: Response to abstinence as a predictor of alcohol risk in women and men.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
affiliation: Psychiatry, Indiana University School of Medicine
name: Martin H Plawecki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychology, Indiana University-Purdue University at Indianapolis
name: Melissa A Cyders, PhD
role: PRINCIPAL_INVESTIGATOR
References: