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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01928758
Eligibility Criteria:
Inclusion Criteria:
* Smoke \>4 cigarettes/day for at least a year
* No quit attempt in prior month
* Not planning to quit smoking within next 6 months
* Plan to live in local area for next 8 months
* Meet diagnostic criteria for a current or lifetime Anxiety Disorder or Mood Disorder as determined by the Mini-international Neuropsychiatric Interview
* Read and write in English
* Women not pregnant or nursing and taking steps to avoid pregnancy
* Able to understand and consent to study procedures
Exclusion Criteria:
* Unstable or significant medical condition such as Chronic Obstructive Pulmonary Disease or kidney failure
* Use of non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior month
* Currently reducing or planning to reduce cigarette consumption in next month
* Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the past 6 months
* Current suicide risk on clinical assessment
* Aged \<18 or \>65
* History of difficulty providing blood samples (fainting, poor venous access)
* Unwilling to remain on one flavor of cigarette (regular or menthol) for the duration of the trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01928758
Study Brief:
Protocol Section:
NCT01928758