Sex Differences in the Response to Abstinence From Alcohol.

Alcohol Use Disorder Clinical Trial

— SPAR  

Official title:

Sex Differences in the Response to Abstinence From Alcohol.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03827460
• Other study ID #: 1809467722
• Secondary ID: R01AA027236-05
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2019
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Ann E Kosobud, Ph.D.
• Phone: (317) 274-0087
• Email: akosobud[@]iupui.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Abstinence from alcohol
Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol
• 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.

Locations

Country	Name	City	State
United States	University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex differences in the effect of abstinence on alcohol self-administration.	The effect of 2 weeks abstinence on intravenous alcohol intake will be compared in men and women.	2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Primary	Sex differences in the effect of abstinence on sensitivity of the P3 response to alcohol.	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.	2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Primary	Sex differences in the effect of abstinence on subjective responses to alcohol.	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.	2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Primary	The role of changes in alcohol elimination on sex differences in response to 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.	2 single day laboratory sessions, one following 2 weeks alcohol abstinence
Primary	Response to abstinence as a predictor of alcohol risk in women and men.	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.	2 years