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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT01399866
Eligibility Criteria:
Inclusion Criteria:
* Participants must have smoked an average of ≥ 10 cigarettes/day during the past 6 months
* have expired air CO ≥ 10 ppm or urine cotinine ≥ 100 ng/mL
* meet DSM-IV criteria for nicotine dependence
* aged 18 - 65
* Recently abstinent participants referred by a PCP, smoking cessation clinic or self referred must have an expired air CO \< 10 ppm to confirm abstinence
Exclusion Criteria:
* Severe or uncontrolled medical or psychiatric illness
* History of multiple hospitalizations within the last six months for an ongoing medical condition
* Any significant, current and unstable cardiovascular disease, end stage renal failure, severe COPD requiring oxygen, any current unstable neurological disease, a history of seizures or epilepsy, or a history of head trauma with lasting neurological sequelae, will be excluded for their safety.
* Major depressive episode, mania or mixed episode in the prior 6 months
* Lifetime history of psychosis, delusional disorder, organic mental disorder by DSM-IV criteria, or ongoing cognitive impairment will also be excluded for their safety,
* Current excessive use of alcohol (\>21 drinks/week in female subjects; \>28 drinks/week in male subjects)
* Current use of illicit drugs.
* Current steroid use, current, daily use of benzodiazepines, or participants who are unwilling to modify their benzodiazepine use will.
* Pregnant or breastfeeding women will be excluded, as well as women of childbearing potential who will not use a medically acceptable method of contraception (i.e. IUD, oral contraceptives).
* Participants who are deaf, blind, or experience any other significant sensory impairment that would preclude them from completing study procedures will also be excluded, as well as participants who are unable to understand study procedures or provide informed consent.
* Participants receiving isoniazid or ethionamide, or who have a known sensitivity to D-cycloserine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01399866
Study Brief:
Protocol Section:
NCT01399866