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:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT01765959
Eligibility Criteria:
Inclusion Criteria:
* men and women (n=40)
* 18-75 years old with: (i) primary or secondary insomnia who have been treated every day for over six months with benzodiazepine-like drugs and developed a low dose drug dependence, and (ii) people suffering from insomnia who use benzodiazepine-like drugs ≥ three nights a week with no effect.
Exclusion Criteria:
* high dose drug dependence,
* generalized anxiety disorder (GAD),
* patients diagnosed with diagnosed psychotic disorders,
* personality disorders or serious somatic illness,
* alcohol dependence/abuse,
* anti psychotic medications,
* pain reliving treatment with methadone- or methadone like drugs,
* new onset depression,
* patients who have initiated or changed their anti-depressant,anxiolytic or pregabalin medication during the last six months,
* pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01765959
Study Brief:
Protocol Section:
NCT01765959