Sex Differences in the Response to Abstinence From Alcohol.
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 35 |
| Updated: | 4/3/2019 |
| Start Date: | March 15, 2019 |
| End Date: | August 31, 2024 |
| Contact: | Ann E Kosobud, Ph.D. |
| Email: | akosobud@iupui.edu |
| Phone: | (317) 274-0087 |
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.
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.
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..
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..
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
Exclusion Criteria:
- Pregnant or breast-feeding women
- Desire to be treated for any substance use disorder or court ordered to not drink
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
We found this trial at
1
site
Indianapolis, Indiana 46122
Principal Investigator: Martin H Plawecki, MD, PhD
Phone: 317-948-6551
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