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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT00691132
Eligibility Criteria:
Inclusion criteria:
Initial from phone interview:
* Currently smoking 10-45 cigarettes per day for the past year;
* Between the ages of 21 and 70 years;
* In apparently good physical health with no unstable medical conditions including seizures or cancer;
* In stable and good mental health, i.e., currently do not experience unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria, during the past six months;
* Not using any other tobacco or nicotine-containing products;
* Not on methadone maintenance or stimulants such as ephedra; not a regular user of street drugs and if uses occasionally, willing to abstain during the study; not taking any drugs known to be P4501A6 substrates such as phenobarbital, rifampicin, dexamethasone, ketoconazole, methoxsalen, pilocarpine, or tranylcypromine due to their role in NNK metabolism;
* Does not average more than 21 alcoholic drinks per week;
* Willing to perform study activities such as having blood sample drawn, urine collection, multiple clinic visits;
* For female subjects of child bearing potential, not known to be pregnant or nursing, or planning to become pregnant within next 12 months.
For enrollment in the Short-Term Trial:
* Subjects who are generally healthy with liver enzyme and blood count values within the ranges shown below based on blood samples drawn at the second screening visit. Specifically:
* White blood cells ≥ 3,000/mL
* Total bilirubin ≤ 1.5 x upper limits of normal (ULN)
* AST (SGOT)/ALT (SGPT) ≤ 2.5 x ULN
* BUN and serum creatinine ≤ 1.5 x ULN
For enrollment in the Long-Term Trial:
* Participated in the short-term trial and invited to participate in the long-term trial;
* Possess the GSTM1 null-null genotype;
* Smoke 20 or more cigarettes/day with a cumulative smoking history of 20 or more pack-years (one pack-year equals to smoking a pack of cigarettes a day for one year);
* Normal liver enzymes based on blood sample drawn during 1 month wash-out;
* Determined to be a good candidate for the bronchoscopy procedure by a primary care physician.
Exclusion Criteria:
* Subjects with uncontrolled hypertension, uncontrolled diabetes mellitus, unstable coronary artery disease, history of cancer other than non-melanoma skin cancer, and pregnant or lactating women will not be eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00691132
Study Brief:
Protocol Section:
NCT00691132