Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Clinical Trial to Reduce Harm From Tobacco
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation RCT among Vitality/Discovery beneficiaries. The investigators will be able to determine the effectiveness of 4 different interventions aimed at smoking cessation, two of which are incentive structures that are each grounded in behavioral economic principles. The other interventions will determine the effectiveness of various cessation aids, including electronic cigarettes and text messaging, on smoking cessation. This study will be conducted as an opt-out procedure where participants are automatically enrolled in the program but have the choice to unenroll if they so chose. This pragmatic approach will allow us to investigate the effects of such programs in an employee based population that can be easily mimicked in other employee based populations.


Options:
A: Inclusion Criteria:

* healthy smokers
* unwilling to quit
* age 18-60 years
* smoking ≥ 15 cig/day for at least 5 years
* exhaled CO level of ≥ 15 ppm
* FTND ≥ 5

Exclusion Criteria:

* alcohol and illicit drug use
* breastfeeding or pregnancy
* major depression or other psychiatric conditions
* previous experience with ENDD
* recent myocardial infarction
* angina pectoris
* high blood pressure (BP\>140mm Hg systolic and/or 90mmHg diastolic)
* diabetes mellitus
* severe allergies
* poorly controlled asthma or other airways diseases
B: Inclusion Criteria:

* Vitality beneficiary
* 18 years or older
* reported and/or tested positive for being a smoker
* all participants will be able to opt-out of this program.

Exclusion Criteria:

* Participants who express wanting to opt-out of this program will be un-enrolled and excluded
C: Inclusion Criteria:

Participants must:

1. be aged 18 years or older
2. reside in Washington, D.C. metro area (including VA and MD suburbs)
3. be proficient in English
4. be daily smoker with at least 5 years of established daily smoking

   * A person will be categorized as a daily smoker if he reports daily smoking of at least 8 cigarettes a day for the past 5 years, and records an exhaled air carbon monoxide (CO) level \> 8 parts-per-million (ppm) at the baseline in-person meeting.
   * Daily smokers will be eligible for the main study if they do not intend to quit in the next 30 days.
   * If they do intend to quit in the next 30 days, eligible daily smokers will be enrolled in the second arm of the study.
5. not taking smoking cessation medications;
6. smoked LCC/cigars/hookah less than 5 times in last 30 days
7. have not used other tobacco products in last 30 days
8. have not used an ENDS product (electronic cigarette) in the last 30 days
9. be interested in trying an ENDS
10. have an iPhone or Android that allows installation of applications and use it daily
11. have a phone plan that allows unlimited text messages
12. be willing to travel to the data collection cite four times in three weeks
13. not be breastfeeding or planning to become pregnant
14. not have heart disease/uncontrolled blood pressure
15. not have psychosis/suicidal thoughts
16. not be currently enrolled in an alcohol treatment program
17. not be out of town for more than 5 nights in the next 6 weeks

Exclusion Criteria:

* Individuals who do not satisfy the criteria above will not be eligible for this study.
* There will be no involvement of vulnerable populations.
D: Inclusion Criteria:

* Participants (N=1100) will be men and women 18 years of age and older, recruited from four acute inpatient psychiatry units at the Alta Bates Summit Medical Center - Herrick Campus, located in Berkeley, CA, one acute inpatient psychiatry unit at Langley Porter Psychiatric Institute, located in San Francisco, CA, and two acute inpatient psychiatry units at Stanford Hospital, located in Stanford, CA. Inclusion criteria are: smoking 5 or more cigarettes per day and at least 100 cigarettes in one's lifetime, no plan to relocate outside of the greater Bay Area in the next 18 months, and telephone access for scheduling follow-up assessments.

Exclusion Criteria:

* Study exclusion criteria are: dementia or other brain injury precluding ability to participate; non-English speaking; complete homelessness; pregnancy or breastfeeding, and active ulcer disease (PUD). The relationship between nicotine and ulcers is a theoretical concern and our approach to now exclude patients with active ulcer disease is conservative. There is no data to show NRT causes/worsens ulcers. Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to consent to study participation. Threats of violence in particular are taken seriously, and patients will not be recruited if they may be a threat to study staff in the outpatient setting. At this point, non-English measurement and intervention materials are not available. Pregnant smokers will be referred out for more specialized behavioral treatments. Exclusionary criteria are purposefully minimal in order to maximize information about treating tobacco dependence in smokers in inpatient psychiatry. The study sample is anticipated to be diverse with respect to gender and ethnicity, educational and socioeconomic level, and psychiatric diagnoses.

Answer: B