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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT03627832
Eligibility Criteria:
Inclusion Criteria:
* Age 18-30 years
* Heavy episodic drinking, defined as 1 heavy drinking episode (4/5+ drinks for women/men) in the past 30 days on the Timeline Followback
* DSM-5 criteria for insomnia, with "daytime impairment" operationalized as ISI scores =\>10
Exclusion Criteria:
* Unable to provide informed consent
* New sleep medication in the past 6 weeks
* Contraindications for CBT-I (mania or seizure disorder)
* Severe psychiatric disorder that requires clinical attention (PTSD, major depression)
* Current treatment for insomnia or alcohol use
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT03627832
Study Brief:
Protocol Section:
NCT03627832