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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04396834
Eligibility Criteria:
Inclusion Criteria:
1. age 18-65
2. smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence \> 90 days
3. biochemical verification of smoking status
4. at least low to moderate nicotine dependence
5. reporting long-term motivation to quit smoking
6. willingness to take study pills and complete study procedures
7. willingness to complete lab sessions involving cigarette smoking
Exclusion Criteria:
1. meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder
2. recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen
3. past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes
4. past 30-day use of SSRIs, other psychiatric medications, or weight control medications
5. lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)
6. significant medical or neurological illness, including severe hepatic impairment or cirrhosis, or insulin dependent diabetes
7. actively engaged in smoking cessation treatments or a smoking cessation attempt (or intent to start an attempt in the next 90 days)
8. interested in quitting smoking immediately (i.e., in the next two months)
9. Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
10. body mass index (BMI) under normal range (BMI \< 18 kg/m2)
11. history of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heart attack, stroke, unstable angina
12. abnormal electrocardiogram (ECG) results
13. nursing, pregnant, or anticipating pregnancy
14. history of suicide attempt or recent suicidal thoughts (intent or plan) in the last month
15. Plans to travel outside of the local area during the study period, or inability to commit to entire duration of study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04396834
Study Brief:
Protocol Section:
NCT04396834