Neural and Hormonal Influences on Alcohol Use Disorder Risk

Recruiting at 1 trial location

Overseen By Jessica Weafer, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Jessica Weafer

Must not be taking: Hormonal contraception

Disqualifiers: Serious medical problems, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why men and women experience alcohol use disorder (AUD) differently. Researchers examine how brain functions and hormones influence drinking habits, focusing on self-control, emotional responses, and reactions to alcohol cues. The trial includes separate groups for men and women, with women's data further divided by menstrual cycle phases. It seeks participants who consume at least 4-5 alcoholic beverages a week, have regular menstrual cycles (for women), and are right-handed. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research on gender differences in AUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have medical or psychiatric conditions that require medication where alcohol is not allowed.

What prior data suggests that this protocol is safe for participants?

Research shows that the safety of treatments focusing on brain and hormone effects for Alcohol Use Disorder (AUD) remains under investigation. The trial under consideration is labeled "Not Applicable" for its phase, indicating a lack of specific safety data from earlier trial phases. This suggests that the primary goal is to gather information rather than test a new drug or procedure.

The trial aims to understand how differences in the brain and hormones affect AUD risk in men and women. It does not involve a new medication or surgery, which generally means a lower risk of side effects. However, as it is research-based, minor risks may arise from tests or assessments conducted during the study. Prospective participants should consult with the research team to fully understand what participation involves. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how neural and hormonal factors influence alcohol use disorder (AUD) risk, particularly how these influences vary between males and females. Unlike traditional treatments that primarily focus on behavior modification or medication to manage AUD symptoms, this study aims to uncover the underlying biological differences that might contribute to the disorder. By examining sex differences, especially considering factors like the menstrual cycle in females, the research could pave the way for more personalized and effective prevention strategies in the future. This approach offers the potential to revolutionize how we understand and treat AUD, making it more tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder?

Research shows that women with Alcohol Use Disorder (AUD) might face different risks due to hormones. Studies have found that women who drink often use less of the brain areas that control impulses, making it harder for them to stop drinking. Estradiol, a hormone that changes during the menstrual cycle, seems to affect this difference. Understanding these brain and hormone differences is crucial for developing specific treatments for AUD in women. This trial will explore these neural and hormonal influences to discover how these factors could lead to better prevention and treatment strategies for both men and women. Participants will be divided into two groups: males and females, with data for females segregated by menstrual cycle phase. ^{1 2 3 4 6}

Who Is on the Research Team?

Jessica Weafer, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for English-speaking, right-handed individuals with at least a high school education who regularly consume alcohol. Women must have regular menstrual cycles and not be pregnant, nursing, or on hormonal contraception. Participants should weigh between 110 and 210 lbs and not require medication that interacts badly with alcohol.

Inclusion Criteria

fluent in English

I have regular menstrual cycles.

You drink around 4 to 5 alcoholic drinks every week.

Exclusion Criteria

current or recent history of inpatient/intensive treatment for addictive behaviors

I take medication that shouldn't be mixed with alcohol due to my health condition.

My weight is either below 110 lbs or above 210 lbs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including neural inhibitory function, negative emotionality, and alcohol cue reactivity tasks

1-2 weeks

1 visit (in-person)

Experimental Sessions

Participants engage in tasks such as the stop signal task, Emotional Pictures Task, and Alcohol Cue Reactivity Task to measure neural responses

Varies per task

Multiple visits (in-person)

Follow-up

Participants are monitored for prospective alcohol consumption and self-reported current alcohol consumption

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Neural and Hormonal Influences on Sex Differences in Risk for AUD

Trial Overview The study aims to understand why women are increasingly at risk for Alcohol Use Disorder (AUD) by examining brain function and hormone levels related to self-control, emotional response, and reactions to alcohol cues.

How Is the Trial Designed?

Group I: Males Experimental Treatment 1 Intervention

Participants in this group will be adult male drinkers.

Group II: Females Experimental Treatment 1 Intervention

Participants in this group will be adult female drinkers. Data will be segregated by menstrual cycle phase.

Who Is Running the Clinical Trial?

Jessica Weafer

Lead Sponsor

Trials

5

Recruited

560+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Gender differences in alcohol intake and response may be significantly influenced by variations in brain organization and neurosteroid levels between males and females.

The study suggests that these brain differences could explain the varying risks for alcoholism and the different behavioral and neurochemical responses to alcohol in men and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender differences in the brain: implications for the study of human alcoholism. Lancaster, FE.[2019]

Recent trends show that the gap in alcohol use disorder (AUD) prevalence between men and women is narrowing, highlighting the need to understand sex-specific factors in alcohol consumption.

The review emphasizes the role of sex hormones and stress-related steroids in influencing alcohol drinking behaviors, suggesting that treatment strategies for AUD may need to be tailored differently for males and females, particularly regarding the targeting of specific hormonal pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Endocrine System and Alcohol Drinking in Females. Finn, DA.[2021]

Early exposure to sex hormones can lead to structural changes in the brain that increase the risk of alcohol addiction later in life, suggesting a critical developmental window for these effects.

The review highlights the importance of both organizational and activational effects of sex hormones on alcohol-related behaviors, indicating that understanding these mechanisms could help in creating better prevention and treatment strategies for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex hormone activity in alcohol addiction: integrating organizational and activational effects. Lenz, B., Müller, CP., Stoessel, C., et al.[2015]

In a study using an ethanol self-administration model with rats, it was found that female rats maintained a preference for alcohol longer than males, suggesting that brain sexual differentiation influences drinking behavior.

Gonadal hormones like dihydrotestosterone in males and estradiol in females modulate alcohol consumption, with dihydrotestosterone reducing intake in castrated males and estradiol decreasing intake in ovariectomized females, indicating hormonal effects on alcohol preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender differences in ethanol preference and ingestion in rats. The role of the gonadal steroid environment. Almeida, OF., Shoaib, M., Deicke, J., et al.[2018]

Alcohol use disorder (AUD) has seen a dramatic increase in women over the past decade, with rates rising by 84%, highlighting the urgent need to understand the neural mechanisms behind this trend.

Current neuroimaging research on AUD shows mixed results regarding sex/gender differences in brain function and structure, indicating a significant gap in understanding how these differences may influence alcohol consumption and the risk of AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex/gender differences in brain function and structure in alcohol use: A narrative review of neuroimaging findings over the last 10 years. Verplaetse, TL., Cosgrove, KP., Tanabe, J., et al.[2021]

A systematic review of 50 studies found that higher testosterone levels are linked to increased alcohol consumption and risk of alcohol use disorder (AUD) in males, while the effects in females remain unclear.

In females, increased estrogen levels are associated with higher alcohol use, but findings in males are mixed, highlighting the need for more research on how different sex hormones influence alcohol behavior in both sexes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex hormones in alcohol consumption: a systematic review of evidence. Erol, A., Ho, AM., Winham, SJ., et al.[2022]

Ovariectomy in female rats reduced ethanol drinking levels by 15%, indicating that the removal of ovarian steroids can influence alcohol consumption, similar to the drinking levels observed in male rats.

Despite the hormonal changes, both intact and ovariectomized female rats showed similar responses in GABA(A) and NMDA receptor alterations due to chronic ethanol exposure, suggesting that ovarian steroids do not significantly affect the gender differences in receptor changes associated with ethanol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovariectomy has minimal effects on neuroadaptations associated with ethanol dependence in female rats. DevaudLL, ., Morrow, AL., Nguyen, UT.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04929288

Neural and Hormonal Influences on Sex Differences in ... The goal of this study is to identify the mechanisms underlying sex-specific risk for AUD, and ultimately to help develop sex-specific prevention and treatment ...

2. trialx.com trialx.com/clinical-trials/listings/277983/neural-and-hormonal-influences-on-sex-differences-in-risk-for-aud/

Neural and Hormonal Influences on Sex Differences in ... The overall objective of this trial is to determine the neural and hormonal factors contributing to sex-specific risk for AUD in three addiction ...

3. scholars.uky.edu scholars.uky.edu/en/projects/sex-differences-in-risk-for-alcohol-use-disorder-neural-and-hormo-2

Sex Differences in Risk for Alcohol Use Disorder: Neural and ... Moreover, we have preliminary evidence that female drinkers show less engagement of neural circuitry underlying inhibitory control, and that this sex difference ...

4. withpower.com withpower.com/trial/phase-alcoholism-4-2021-88016

Neural and Hormonal Influences on Alcohol Use Disorder ... Current neuroimaging research on AUD shows mixed results regarding sex/gender differences in brain function and structure, indicating a significant gap in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7532022/

Sex Differences in the Neurobiology of Alcohol Use Disorder Sex differences may play a critical role in modulating how chronic or heavy alcohol use impacts the brain to cause the development of alcohol use disorder (AUD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8238910/

Neural mechanisms of sexual decision making in women with ... Results showed that sexual cues were more often endorsed by women with AUD compared to controls, and elicited differential brain activation patterns in frontal, ...