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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT00992550
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 65 years
* Gender: Equal #s male \& female
* Ethnic/Racial Group: Any
* Smoking Status: Smokers of approximately 3 - 10 cigarettes per day; cotinine level of \>20 ng/ml.
Exclusion Criteria:
* Medical: Exclude most any chronic illness requiring regular medication.
* Cardiac: History of angina or other serious heart disease; ECG abnormalities on screening.
* Hypertension: screening visit BP of 150/95 or more after 5 min rest
* Respiratory: Asthma - okay if in remission, otherwise exclude.
* Systemic: "Morbidly Obese" Exclude if BMI \> 35
* Diabetes: By history
* Chronic Active Hepatitis: By history; elevated liver function tests (LFTs)
* Cancers: By history
* Pregnancy/breastfeeding: By history; positive pregnancy test
* Other tobacco users (pipe, cigar, chewing tobacco, snuff users
* The following list of health conditions are routinely asked at Phone Screening and thus are exclusions "by history":
* Oral thrush,
* Glaucoma,
* Thyroid disease,
* Urinary retention,
* Ulcer in past year,
* Other "life threatening" illness,
* "Bad veins"; discomfort with blood draws,
* History of persistent fainting,
* Psychiatric (Any history of schizophrenia, major depression, or psychiatric hospitalization),
* Also any condition for which medications are being taken on a regular basis.
* Medications/Supplements: General Exclusion = "any regular oral and/or prescription drug use" with the exception of oral contraceptives and Thyroid (Synthroid)
* Drug/alcohol use: General "no abuse by history", no regular recreational drug use, any intravenous drug abuse (IVDA), recent hx of Tx program No smoking of marijuana or herbal products for one month prior to screening and no smoking of marijuana or herbal products between screening and final study day.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00992550
Study Brief:
Protocol Section:
NCT00992550