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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT00833404
Eligibility Criteria:
Inclusion Criteria:
* Male
* Between the ages of 25 and 60
* Proficient in English
* Currently smoke at least 15 cigarettes per day for at least 5 years
* Heterosexual
* Currently sexually active (sexual intercourse within the past 30 days)
* Committed to quit smoking
Exclusion Criteria:
* History of HIV infection or active, untreated pelvic or urinary tract infection including, sexually transmitted diseases such as chlamydia genital herpes, gonorrhea, or syphilis.
* Major pelvic surgery that may have caused nerve damage, or serious bladder, rectal, or abdominal surgery.
* Neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
* Clinically significant untreated renal or endocrine disease.
* Uncontrolled hypotension or hypertension manifested by systolic blood pressure \>170 or \<90 mm Hg or diastolic blood pressure \>100 or \<50 mm Hg.
* History of serious drug abuse or serious alcohol abuse within the past 12 months (\>= 16 points on the Alcohol Use Disorders Identification Test (AUDIT) and \>= 6 on the Drug Abuse Screening Test (DAST-10).
* Evidence of schizophrenia, bipolar disorder, delusional disorder, or psychotic disorders not classified elsewhere as per the DSM-IV
* Using medications known to affect sexual or vascular functioning, including antidepressants and anti-hypertensives, as well as sildenafil, vardenafil, tadalafil, or any other substance designed to affect sexual performance
* Patients using insulin, narcotic pain relievers (propoxyphene, pentazocine), tricyclic antidepressants, oxazepam, or medications for respiratory diseases such as COPD or asthma (xanthines (e.g., theophylline) as these drugs are contraindicated by the nicotine patch
* Patients who report experiencing clinically significant sexual difficulties, including hypoactive sexual desire disorder, sexual arousal disorder, premature ejaculation, or inhibited orgasm prior to the onset of smoking.
* Recent myocardial infarction, serious heart arrhythmias, and those with serious or worsening angina.
* Hypersensitivity or allergy to nicotine.
* History of or current psoriasis, dermatitis (atopic or eczematous), active peptic ulcers, severe renal impairment, hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes mellitus.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
23 Years
Maximum Age:
60 Years
Study:
NCT00833404
Study Brief:
Protocol Section:
NCT00833404