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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT03262233
Eligibility Criteria:
Inclusion Criteria:
* cigarette use over 10 cigarettes/day for over two years;
* smoking within the first 30 minutes of waking up
* expired air carbon monoxide (CO) level \>6 ppm
* self-reported motivation to quit smoking
* and an agreement to respond to ecological momentary assessment prompts (via SMS) throughout the day for three weeks.
Exclusion Criteria:
* Health screening are performed by questionnaire and reviewed by study staff (RA or Research Specialist) to ensure that smokers can safely use the nicotine patch and lozenge. Specifically, smokers will be excluded for FDA contraindications for nicotine replacement therapy (i.e., no uncontrolled hypertension, recent myocardial infarction, diabetes, heart disease, asthma, stomach ulcers).
* All women of child-bearing potential will be required to agree to use an approved method of birth control to prevent pregnancy during the course of the study.
* All participants will report no medical or psychiatric condition that would contraindicate exposure to electric shock.
* Participants with uncorrected auditory or visual problems will be excluded.
Additional Data Exclusions
1. As part of the NPU stressor task, smokers are asked to indicate if the participant "can be shocked in the next 5 seconds" at various points during the task. Responses to these questions are used to verify that the participant understands the cue-shock contingencies. Smokers who answer \< 10 out of 14 questions correctly the NPU stressor task during the experimental session will be excluded from all analyses and replaced.
2. Smokers with 20% of cue trials identified as artifact in the NPU task will be excluded from all analyses and replaced.
3. The analysis will NOT exclude smokers who are startle non-responders given that the use of these surrogate endpoints in practice would likely need to include these individuals to avoid unnecessary data loss.
4. Smokers who do not report a complete abstinence between quit date/time and final laboratory visit (which occurs 12-36 hours later) will be considered to not have quit and will be excluded from all analyses and replaced.
5. Smokers for whom the investigators cannot definitively quantify an outcome with respect to continuous abstinence will be excluded from all analyses and replaced. Any report of smoking during the two-week cessation period (reported either during the 4x daily web surveys or the laboratory visit at 2 weeks) is sufficient to code the smoker to have lapsed (i.e., not continuously abstinent), even if the participants do not complete the full two weeks of web surveys and/or the 2-week laboratory visit. However, the status of smokers who report no smoking during the cessation attempt but have both a high level of missing data from the web surveys (\> 25% of reports) and no two-week laboratory visit report will be deemed uncertain. These smokers will be excluded and replaced.
6. The investigators will conduct case analyses to identify participants who are model outliers with Bonferroni-corrected studentized residuals p \< 0.05. These model outliers will be excluded but NOT replaced (because the participants are not identified until after data collection has been completed).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03262233
Study Brief:
Protocol Section:
NCT03262233