Please select the eligibility criteria that correspond to the clinical trial below.
Title: Enhancing Smoking Cessation in the Homeless Population
Brief Summary: The goal of this research study is to enhance smoking cessation rates for homeless smokers. The original study design proposed to test the effects of 1) an Intensive Smoking Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will utilize a 3-group randomized design to test study hypotheses. The three study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A); 2) Intensive Smoking Intervention using CBT-(IS); or 3) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). Due to low enrollment because of the addition of an alcohol use screening criteria, the study was changed to a two arm study and the study time frame changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy (CBT), CBT-(IS+A) and 2) Usual Care (brief smoking cessation and brief alcohol counseling both based on the United States Public Health Service's Guidelines)-(UC). The study length is reduced to 26 weeks from 52 weeks. All participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge. Counseling will follows the protocol used in a recent study of alcohol dependent smokers and will include weekly individual sessions for 3 months followed by study data collection visits 3 months. Both study conditions will have equal number of study contacts. Study staff will make retention contacts with participants in the community during weeks that do not have study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16, and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90 days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes, other non-monetary incentives, attractive intervention materials, collaboration with homeless shelters, and advice from a Community Advisory Board. Participants will be enrolled from homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our power calculation indicates that a sample size of 215 per study condition is needed to detect proposed treatment effects.


Options:
A: Inclusion Criteria:

* currently homeless
* smoke 5 or more cigarettes per day
* smoked 100 cigarettes in lifetime
* aged 18 years or older

Exclusion Criteria:

* unstable mental illness
* pregnancy
* current history of psychoactive or alcohol dependence or psychotic disorder
* cognitive impairment
B: Inclusion Criteria:

* Current cigarette smoker of at least 10 cigarettes per day
* Interested in quitting at some time
* Not currently interested in quitting smoking
* Access to telephone (home or work) for 6 month study period

Exclusion Criteria:

* Monthly cigar, pipe, or smokeless tobacco use
* Current pregnancy or breastfeeding
* Recent cardiovascular distress
* Phenylketonuria (PKU)
* Previous use of nicotine replacement therapy (gum, patch, lozenge, inhaler, or nasal spray)
C: Inclusion Criteria:

* Currently Homeless
* Smoked at least 100 cigarettes in lifetime
* AUDIT score of \> or equal to 5, \< or equal to 26
* Aged 18 years or older
* Willing to attend study sessions and follow other study protocol

Exclusion Criteria:

* Use of smoking cessation medications or interventions in last 30 days
* Unstable medical illness that requires immediate medical care
* AUDIT score of \< 5 or \> 26
* Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications
* Current history or in past 6 months of psychotic disorder or major depressive disorders that is not stable on treatment for past 3 months
* Cognitive impairment
D: Inclusion Criteria:

* Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers.
* Age ≥18 years old, assessed by self-report and verified by date of birth.
* Has smoked ≥100 cigarettes and currently smokes ≥5 cigarettes per day, verified by an exhaled carbon monoxide level of ≥8 ppm.
* Ready to try quitting smoking within the next month.
* Currently homeless, assessed by self-report and defined as usually staying in an emergency shelter, transitional shelter, abandoned building, place of business, car or other vehicle, church or mission, hotel or motel, or anywhere outside during the past 7 days. Additionally, individuals will be considered currently homeless if they usually stayed in somebody else's house, apartment/condominium, or room in the past 7 days because of not having their own place to stay.

Exclusion Criteria:

* Currently pregnant, assessed by a urine pregnancy test conducted on all premenopausal biologic females who have not had a hysterectomy, or planning to become pregnant in the next 2 months.
* Past 30-day use of nicotine replacement therapy, bupropion, or varenicline for smoking cessation, assessed by self-report. Use of bupropion for reasons other than to quit smoking (e.g. depression) is permissible.
* Prior serious adverse reaction to the nicotine patch, defined as any reaction that was life-threatening or required hospitalization.
* Heart attack or chest pain within the past 2 weeks.
* Inability to read a sentence written at a Flesch-Kincaid grade level of 4.
* Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate.

Answer: C