Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT04057534
Eligibility Criteria:
Inclusion Criteria:
* severe alcohol (AUD) or tabacco use disorder (SUD) according to DSM-5
* abstinence from alcohol for at least 72 hours (AUD)
* sufficient ability to communicate with investigators and answer questions in both written and verbal format
* ability to provide fully informed consent and to use self-rating scales
* main diagnosis AUD: inpatient or outpatient treatment in our clinic
* main diagnosis TUD: participation in 6 weeks smoking cessation treatment
* Normal or corrected to normal vision
* Signed consents for data security
Exclusion Criteria:
* severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for other substance use disorders - if AUD or TUD is still the main diagnosis -, ADHD, remitted depression, mild or moderate depression, adjustment disorder, generalized anxiety disorder, phobias, panic disorder or other mild or moderate personality disorders) in the last 12 months
* Severe withdrawal symptoms (CIWA-Ar \> 7; Sullivan et al. 1989)
* alcohol intoxication (\>0‰)
* history of brain injury
* severe cognitive impairments
* common exclusion criteria for MRI (e.g. metal, claustrophobia, pregnancy)
* suicidality or endangerment of others
* positive Covid-19 screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04057534
Study Brief:
Protocol Section:
NCT04057534