Skip to content

Behavioral and Neurobiological Changes over the Course of the Menstrual Cycle in Women with Alcohol Use Disorder

Behavioral and Neurobiological Changes over the Course of the Menstrual Cycle in Women with Alcohol Use Disorder - Cycle-AUD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032029
Enrollment
72
Registered
2023-12-20
Start date
2024-01-15
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DSM-5 Alcohol Use Disorder

Interventions

Group 1: Women with alcohol use disorder (AUD) are studied continuously over a period of three menstrual cycles via smartphone entries and attend comparative laboratory sessions during the ovulatory c

Sponsors

Zentralinstitut für Seelische Gesundheit (ZI)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 42 Years

Inclusion criteria

Inclusion criteria: - Female sex at birth - Regular menstrual cycle with a duration between 21 and 35 days in the last three months - Body mass index 18.5-30.0 kg/m² - AUD according to DSM-5 (American Psychiatric Association, 2013) - Ability to give informed written consent and to undergo functional magnetic resonance imaging - Written Informed Consent available - Sufficient knowledge of the German language - Breath alcohol concentration of 0.0 per mille

Exclusion criteria

Exclusion criteria: - Medical history of bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance use disorder other than alcohol, nicotine, or cannabis, treated as an outpatient or inpatient - History of severe head injury or other severe central nervous system disease (e.g., dementia, Parkinson's disease, multiple sclerosis) - Intake of drugs or medications that interact with the central nervous system within the last 10 days or if their use was less than 5 half-lives in the past - Intake of contraceptives or other hormones that affect the menstrual cycle - Breastfeeding - Active wish to become pregnant - Exclusion criteria for an MRI examination - Known intolerance to high-frequency flickering visual stimuli - Presence of premenstrual dysphoric disorder according to SIPS

Design outcomes

Primary

MeasureTime frame
Alcohol craving (smartphone and laboratory assessment)

Secondary

MeasureTime frame
Daily to weekly smartphone entries in real-life - Alcohol consumption - Control ability - Social contacts - Mood / depressiveness - Mindfulness - Gender roles - Drinking motives fMRI - Alcohol cue reactivity (Alcue task) - Reactivity in a behavioral inhibition task (Stop-signal task) - Emotion processing (Hairiri task) - Resting state synchronicity Virtual reality/ in vivo exposure to alcoholic stimuli - Attentional bias (Dot probe task, alcohol Stroop task)

Countries

Germany

Contacts

Public ContactLeonard P. Wenger, M.Sc.

Zentralinstitut für Seelische Gesundheit (ZI)

leonard.wenger@zi-mannheim.de+49 621 1703 3502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026