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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT02250534
Eligibility Criteria:
Inclusion Criteria:
* Female
* Ages 18-44 years
* Less than an Associate's degree
* Report smoking ≥ 5 cigarettes per day
* Provide an intake breath carbon monoxide (CO) sample \> 8 ppm
* Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the Licensed Medical Professional or PI
* Be without current substance abuse/dependence other than nicotine
* Be sufficiently literate to complete research-related tasks
* Be in good physical health without serious illness or change in health or medication in the past three months as determined by the Licensed Medical Professional at each site
* Not pregnant or nursing and report using oral, implant, patch, ring, intrauterine device (IUD), injection, or barrier contraceptives or report being surgically sterile, or post menopausal
* Report no significant use of other tobacco or nicotine products within the past month (\> 9 days in the past 30)
Exclusion Criteria:
* Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content)
* Exclusive use of roll-your-own cigarettes
* Planning to quit smoking in the next 30 days
* A quit attempt in the past 30 days resulting in \> 3 days of abstinence
* Currently taking anticonvulsant medications
* Positive toxicology screen for illicit drugs not including marijuana (participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once)
* Breath alcohol level \> 0.01 (participants with a positive screen will be allowed to re-screen once)
* Self-report of binge drinking alcohol (\> 9 days in past 30, 4 drinks in 2 hours )
* Systolic blood pressure \< 90 or ≥ 160 mmHg (participants outside the range will be allowed to re-screen once)
* Diastolic blood pressure \< 50 or ≥ 100 mmHg (participants outside the range will be allowed to re-screen once)
* Breath CO \> 80 ppm
* Heart rate \< 45 or ≥ 115 bpm (participants outside the range will be allowed to re-screen once)
* Currently seeking treatment for smoking cessation
* Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion for treatment of depression will be allowed)
* Current symptoms of psychosis, dementia or mania
* Suicidal ideation in the past month
* Suicide attempt in past 6 months
* Participation in another research study in the past 30 days
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT02250534
Study Brief:
Protocol Section:
NCT02250534