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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00937235
Eligibility Criteria:
Inclusion Criteria:
* Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
* Current diagnosis of chronic PTSD (symptom duration \> 3 months) with clinically significant trauma-related symptoms (PSS-I \>= 20)
* Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
* Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
* If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
* Demonstrate the capacity to provide informed consent;
* Speak and read English.
Exclusion Criteria:
* History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
* Current and continuing intimate relationship with a physically or sexually abusive partner;
* Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
* Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
* Current or past history of psychosis (bipolar disorder or schizophrenia);
* History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;
* Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00937235
Study Brief:
Protocol Section:
NCT00937235