Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
Brief Summary: Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.


Options:
A: Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
B: Arm Label: 1, 26Wks, Counseling, CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM) | Arm Label: 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling | Arm Label: 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM) | Arm Label: 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) | Arm Label: 17, 8Wks, Counseling, CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Cognitive Medication Adherence Counseling (CAM) | Arm Label: 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling, Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Intensive Maintenance Counseling | Arm Label: 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Cognitive Medication Adherence Counseling (CAM) | Arm Label: 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback, Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Automated Adherence Prompting Phone Calls | Arm Label: 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum), Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback | Arm Label: 32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback; Type: EXPERIMENTAL; Interventions: Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) | Intervention Type: DRUG; Name: Short Term Combination Nicotine Replacement Therapy (patch + gum); Assigned to Arm(s): 17, 8Wks, Counseling, CAM, AutoCalls, Feedback, 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback, 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback, 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback, 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback, 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback, 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback, 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback, 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback, 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback, 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback, 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback, 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback, 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback, 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback, 32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback | Intervention Type: DRUG; Name: Long Term Combination Nicotine Replacement Therapy (patch + gum); Assigned to Arm(s): 1, 26Wks, Counseling, CAM, AutoCalls, Feedback, 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback, 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback, 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback, 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback, 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback, 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback, 16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback, 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback, 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback, 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback, 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback, 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback, 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback, 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback, 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback | Intervention Type: BEHAVIORAL; Name: Intensive Maintenance Counseling; Assigned to Arm(s): 1, 26Wks, Counseling, CAM, AutoCalls, Feedback, 17, 8Wks, Counseling, CAM, AutoCalls, Feedback, 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback, 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback, 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback, 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback, 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback, 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback, 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback, 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback, 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback, 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback, 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback, 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback, 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback, 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback | Intervention Type: BEHAVIORAL; Name: Cognitive Medication Adherence Counseling (CAM); Assigned to Arm(s): 1, 26Wks, Counseling, CAM, AutoCalls, Feedback, 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback, 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback, 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback, 17, 8Wks, Counseling, CAM, AutoCalls, Feedback, 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback, 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback, 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback, 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback, 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback, 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback, 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback, 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback, 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback, 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback, 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback | Intervention Type: BEHAVIORAL; Name: Electronic Medication Monitoring Device (the Helping Hand) + Feedback; Assigned to Arm(s): 1, 26Wks, Counseling, CAM, AutoCalls, Feedback, 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback, 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback, 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback, 17, 8Wks, Counseling, CAM, AutoCalls, Feedback, 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback, 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback, 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback, 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback, 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback, 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback, 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback, 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback, 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback, 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback, 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback | Intervention Type: BEHAVIORAL; Name: Automated Adherence Prompting Phone Calls; Assigned to Arm(s): 1, 26Wks, Counseling, CAM, AutoCalls, Feedback, 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback, 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback, 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback, 17, 8Wks, Counseling, CAM, AutoCalls, Feedback, 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback, 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback, 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback, 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback, 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback, 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback, 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback, 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback, 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback, 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback, 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback
C: Arm Label: Group I (varenicline and placebo); Type: EXPERIMENTAL; Interventions: Other: Placebo, Other: Tobacco Cessation Counseling, Drug: Varenicline | Arm Label: Group II (placebo, nicotine patch and lozenge); Type: PLACEBO_COMPARATOR; Interventions: Drug: Nicotine Lozenge, Drug: Nicotine Patch, Other: Placebo, Other: Tobacco Cessation Counseling | Intervention Type: DRUG; Name: Nicotine Lozenge; Assigned to Arm(s): Group II (placebo, nicotine patch and lozenge) | Intervention Type: DRUG; Name: Nicotine Patch; Assigned to Arm(s): Group II (placebo, nicotine patch and lozenge) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) | Intervention Type: OTHER; Name: Tobacco Cessation Counseling; Assigned to Arm(s): Group I (varenicline and placebo), Group II (placebo, nicotine patch and lozenge) | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): Group I (varenicline and placebo)
D: Arm Label: NicVAX conjugate vaccine; Type: EXPERIMENTAL; Interventions: Biological: NicVAX vaccine, Drug: Varenicline | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Drug: Varenicline | Intervention Type: BIOLOGICAL; Name: NicVAX vaccine; Assigned to Arm(s): NicVAX conjugate vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): NicVAX conjugate vaccine, Placebo

Answer: A