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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT05041959
Eligibility Criteria:
Inclusion Criteria:
1. Generally healthy
2. Age 21-55
3. Right-handed using a three-item scale
4. Daily smoker of ≥ 6 cigarettes/day
5. Smoking regularly for ≥ 1 year
6. Have a smartphone capable of running the MetricWire application
7. Able to read and understand English
8. Able to identify at least 6 pleasurable activities they do not do concurrently with smoking or associate with smoking.
9. Able to identify at least 6 unique locations/scenarios they do associate with smoking
Exclusion Criteria:
1. Planning to quit smoking within the next 60 days
2. Currently seeking or receiving treatment for smoking cessation
3. Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
4. Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.
5. Positive toxicology screen for illicit drugs
1. Marijuana will be tested for but will not be exclusionary
2. Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
3. Participants with valid prescriptions who report using the medication as directed and meet all other eligibility criteria may be allowed to participate at the PI's discretion
6. Current use of antipsychotic or stimulant medications.
7. Significant health problems or those that would impact scientific goals of the project, including (but not limited to):
1. Cancer, Bronchitis, Emphysema, COPD
2. Asthma or Breathing Problems
3. Insulin-Dependent Diabetes
4. Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
5. Systolic Blood Pressure \> 160, Diastolic Blood Pressure \> 100, HR \> 115 bpm (one re-screen allowed).
6. Glaucoma, color blindness or an uncorrected vision problem
7. Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
8. History of stroke, brain tumor, seizure disorder, or traumatic brain injury
9. Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
10. Claustrophobia
11. Weight \> 350 pounds or unable to fit in the MRI scanner bore
12. Current psychotic disorder, alcohol use disorder or drug use disorder for drugs other than cannabis (moderate or severe only, mild is allowable at PI's discretion). AUD and DUD in remission are also allowable at PI's discretion.
13. Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
8. Current enrollment in another smoking research study or having participated in a study involving daily use of Spectrum cigarettes or other reduced nicotine products within the past three months
9. Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT05041959
Study Brief:
Protocol Section:
NCT05041959