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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT00791869
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 - 65 years
* Gender: Either
* Ethnic/Racial Group: Any
* Smoking Status: Both smokers and non-smokers are eligible
* CYP2B6 genotype: CYP2B6 \*1/\*1 (11 subjects); \*4, \*5 and \*6 alleles (11 each) \[44 subjects total\] Up to 15 additional subjects may be studied with genotypes that do not fall into one of the primary groups.
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 - acceptable if in remission, otherwise exclude.
* Systemic: "Morbidly Obese" Exclude if BMI \> 35
* Diabetes: By history
* Chronic Active Hepatitis: By history; elevated Liver Function Tests
* Cancers: By history
* Pregnancy/breastfeeding: By history; positive urine pregnancy test
* Seizures: individuals with a history of seizures will be excluded (risk factor for bupropion-induced seizures)
* Eating Disorders: individuals with a history of eating disorders will be excluded (risk factor for bupropion-induced seizures)
* Head Trauma: individuals with a history of head trauma will be excluded (risk factor for bupropion-induced seizures)
* Other tobacco users (pipe, cigar, chewing tobacco, snuff users
* Medications/Supplements: General Exclusion = "any regular oral and/or prescription drug use"; current use of oral contraceptives or other female hormones.
* Drug/alcohol use: no alcohol abuse by history, no regular recreational drug use, any intravenous drug abuse, recent history of Treatment program
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00791869
Study Brief:
Protocol Section:
NCT00791869