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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01954966
Eligibility Criteria:
Inclusion Criteria:
* Female and male smokers, aged 18 to 50 years;
* History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion);
* Not seeking treatment at the time of the study for nicotine dependence;
* Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm;
* Clean urine drug screen (marijuana is permissible);
* In good health as verified by medical history;
* For women, not pregnant as determined by pregnancy screening, nor breast feeding.
Exclusion Criteria:
* History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;
* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder;
* Lifetime history of schizophrenia or other psychotic disorder;
* Lifetime substance dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview
* Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview
* Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
* Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01954966
Study Brief:
Protocol Section:
NCT01954966