Please select the arm or intervention descriptions that belong 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: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Varenicline plus Motivational Interviewing counseling | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Varenicline without counseling | Intervention Type: OTHER; Name: Varenicline plus Motivational Interviewing counseling; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Varenicline without counseling; Assigned to Arm(s): 2
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Practice Quit Attempt plus nicotine lozenge | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Practice Quit Attempt only | Intervention Type: OTHER; Name: Practice Quit Attempt plus nicotine lozenge; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Practice Quit Attempt only; Assigned to Arm(s): 2
C: Arm Label: Integrated Intensive Smoking + Alcohol; Type: ACTIVE_COMPARATOR; Interventions: Drug: nicotine patch plus nicotine gum/lozenge, Behavioral: Intensive Alcohol Intervention | Arm Label: Usual Care; Type: PLACEBO_COMPARATOR; Interventions: Drug: nicotine patch plus nicotine gum/lozenge | Intervention Type: DRUG; Name: nicotine patch plus nicotine gum/lozenge; Assigned to Arm(s): Integrated Intensive Smoking + Alcohol, Usual Care | Intervention Type: BEHAVIORAL; Name: Intensive Alcohol Intervention; Assigned to Arm(s): Integrated Intensive Smoking + Alcohol
D: Arm Label: Control (N=25); Type: ACTIVE_COMPARATOR; Interventions: Drug: Transdermal nicotine patch, Behavioral: In-person smoking cessation counseling | Arm Label: Financial rewards (N=25); Type: EXPERIMENTAL; Interventions: Drug: Transdermal nicotine patch, Behavioral: In-person smoking cessation counseling, Behavioral: Contingent financial rewards for smoking abstinence | Arm Label: Text messaging (N=25); Type: EXPERIMENTAL; Interventions: Drug: Transdermal nicotine patch, Behavioral: In-person smoking cessation counseling, Behavioral: Text messages to support smoking abstinence | Intervention Type: DRUG; Name: Transdermal nicotine patch; Assigned to Arm(s): Control (N=25), Financial rewards (N=25), Text messaging (N=25) | Intervention Type: BEHAVIORAL; Name: In-person smoking cessation counseling; Assigned to Arm(s): Control (N=25), Financial rewards (N=25), Text messaging (N=25) | Intervention Type: BEHAVIORAL; Name: Contingent financial rewards for smoking abstinence; Assigned to Arm(s): Financial rewards (N=25) | Intervention Type: BEHAVIORAL; Name: Text messages to support smoking abstinence; Assigned to Arm(s): Text messaging (N=25)

Answer: C