Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Optimized Chronic Care for Smokers: A Comparative Effectiveness Approach; Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit
Brief Summary: The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package. This study is a 2x2x2x2 factorial design. Participants will be randomized to one of two levels on four different factors: 1) Nicotine Mini-Lozenge vs. No Mini-Lozenge, 2) Behavioral Reduction Counseling (intervention: BR) vs. No Behavioral Reduction Counseling, 3) 5Rs Motivation Counseling (intervention 5 R's) vs. No 5Rs Motivation Counseling, and 4) Behavioral Activation Counseling (intervention BA) vs. No Behavioral Activation Counseling. These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown.


Options:
A: Arm Label: Varenicline and Placebo Patch; Type: PLACEBO_COMPARATOR; Interventions: Drug: Varenicline and Placebo Patch | Arm Label: Varenicline and Nicotine Patch; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Nicotine Patch | Intervention Type: DRUG; Name: Varenicline, Nicotine Patch; Assigned to Arm(s): Varenicline and Nicotine Patch | Intervention Type: DRUG; Name: Varenicline and Placebo Patch; Assigned to Arm(s): Varenicline and Placebo Patch
B: Arm Label: Mini-Lozenge, BR, 5Rs, BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: Behavioral Reduction Counseling, Behavioral: 5Rs Motivation Counseling, Behavioral: Behavioral Activation Counseling | Arm Label: Mini-Lozenge, BR, 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: Behavioral Reduction Counseling, Behavioral: 5Rs Motivation Counseling | Arm Label: Mini-Lozenge, BR, No 5Rs, BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: Behavioral Reduction Counseling, Behavioral: Behavioral Activation Counseling | Arm Label: Mini-Lozenge, BR, No 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: Behavioral Reduction Counseling | Arm Label: Mini-Lozenge, No BR, 5Rs, BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: 5Rs Motivation Counseling, Behavioral: Behavioral Activation Counseling | Arm Label: Mini-Lozenge, No BR, 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: 5Rs Motivation Counseling | Arm Label: Mini-Lozenge, No BR, No 5Rs, BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge, Behavioral: Behavioral Activation Counseling | Arm Label: Mini-Lozenge, No BR, No 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Drug: Nicotine Mini-Lozenge | Arm Label: No Mini-Lozenge, BR, 5Rs, BA; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral Reduction Counseling, Behavioral: 5Rs Motivation Counseling, Behavioral: Behavioral Activation Counseling | Arm Label: No Mini-Lozenge, BR, 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral Reduction Counseling, Behavioral: 5Rs Motivation Counseling | Arm Label: No Mini-Lozenge, BR, No 5Rs, BA; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral Reduction Counseling, Behavioral: Behavioral Activation Counseling | Arm Label: No Mini-Lozenge, BR, No 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral Reduction Counseling | Arm Label: No Mini-Lozenge, No BR, 5Rs, BA; Type: EXPERIMENTAL; Interventions: Behavioral: 5Rs Motivation Counseling, Behavioral: Behavioral Activation Counseling | Arm Label: No Mini-Lozenge, No BR, 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Behavioral: 5Rs Motivation Counseling | Arm Label: No Mini-Lozenge, No BR, No 5Rs, BA; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral Activation Counseling | Arm Label: No Mini-Lozenge, No BR, No 5Rs, No BA; Type: EXPERIMENTAL; Interventions: Other: No Treatment | Intervention Type: DRUG; Name: Nicotine Mini-Lozenge; Assigned to Arm(s): Mini-Lozenge, BR, 5Rs, BA, Mini-Lozenge, BR, 5Rs, No BA, Mini-Lozenge, BR, No 5Rs, BA, Mini-Lozenge, BR, No 5Rs, No BA, Mini-Lozenge, No BR, 5Rs, BA, Mini-Lozenge, No BR, 5Rs, No BA, Mini-Lozenge, No BR, No 5Rs, BA, Mini-Lozenge, No BR, No 5Rs, No BA | Intervention Type: BEHAVIORAL; Name: Behavioral Reduction Counseling; Assigned to Arm(s): Mini-Lozenge, BR, 5Rs, BA, Mini-Lozenge, BR, 5Rs, No BA, Mini-Lozenge, BR, No 5Rs, BA, Mini-Lozenge, BR, No 5Rs, No BA, No Mini-Lozenge, BR, 5Rs, BA, No Mini-Lozenge, BR, 5Rs, No BA, No Mini-Lozenge, BR, No 5Rs, BA, No Mini-Lozenge, BR, No 5Rs, No BA | Intervention Type: BEHAVIORAL; Name: 5Rs Motivation Counseling; Assigned to Arm(s): Mini-Lozenge, BR, 5Rs, BA, Mini-Lozenge, BR, 5Rs, No BA, Mini-Lozenge, No BR, 5Rs, BA, Mini-Lozenge, No BR, 5Rs, No BA, No Mini-Lozenge, BR, 5Rs, BA, No Mini-Lozenge, BR, 5Rs, No BA, No Mini-Lozenge, No BR, 5Rs, BA, No Mini-Lozenge, No BR, 5Rs, No BA | Intervention Type: BEHAVIORAL; Name: Behavioral Activation Counseling; Assigned to Arm(s): Mini-Lozenge, BR, 5Rs, BA, Mini-Lozenge, BR, No 5Rs, BA, Mini-Lozenge, No BR, 5Rs, BA, Mini-Lozenge, No BR, No 5Rs, BA, No Mini-Lozenge, BR, 5Rs, BA, No Mini-Lozenge, BR, No 5Rs, BA, No Mini-Lozenge, No BR, 5Rs, BA, No Mini-Lozenge, No BR, No 5Rs, BA | Intervention Type: OTHER; Name: No Treatment; Assigned to Arm(s): No Mini-Lozenge, No BR, No 5Rs, No BA
C: Arm Label: Smoking counseling, Placebo; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Smoking counseling, Drug: placebo | Arm Label: Smoking counseling, Varenicline; Type: EXPERIMENTAL; Interventions: Behavioral: Smoking counseling, Drug: varenicline | Intervention Type: BEHAVIORAL; Name: Smoking counseling; Assigned to Arm(s): Smoking counseling, Placebo, Smoking counseling, Varenicline | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): Smoking counseling, Varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Smoking counseling, Placebo
D: Arm Label: Varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline(Chantix) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Varenicline(Chantix); Assigned to Arm(s): Varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B