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

Recruiting

• Conditions: DSM-5 Alcohol Use Disorder

• Registration Number: DRKS00032029
• Lead Sponsor: Zentralinstitut für Seelische Gesundheit (ZI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 72

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alcohol craving (smartphone and laboratory assessment)

Secondary Outcome Measures

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