Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Brief Summary: Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.


Options:
A: Arm Label: mHealth self-help + varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Varenicline, Behavioral: Cognitive-behavioral self-help | Arm Label: mHealth MyMAP program + varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline, Behavioral: Cognitive-behavioral self-help, Behavioral: MyMAP (My Mobile Advice Program) | Intervention Type: DRUG; Name: Varenicline; Assigned to Arm(s): mHealth MyMAP program + varenicline, mHealth self-help + varenicline | Intervention Type: BEHAVIORAL; Name: Cognitive-behavioral self-help; Assigned to Arm(s): mHealth MyMAP program + varenicline, mHealth self-help + varenicline | Intervention Type: BEHAVIORAL; Name: MyMAP (My Mobile Advice Program); Assigned to Arm(s): mHealth MyMAP program + varenicline
B: Arm Label: 2 Weeks of Nicotine Patch Only, No CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch | Arm Label: 2 Weeks of Nicotine Patch Only plus CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Behavioral: CMAC | Arm Label: 2 Wks Nicotine Patch+Nic Gum, No CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Drug: Nicotine gum | Arm Label: 2 Wks Nicotine Patch+Nic Gum plus CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: CMAC | Arm Label: 6 Weeks of Nicotine Patch Only, No CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch | Arm Label: 6 Weeks of Nicotine Patch Only plus CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Behavioral: CMAC | Arm Label: 6 Wks Nicotine Patch+Nic Gum, No CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Drug: Nicotine gum | Arm Label: 6 Wks Nicotine Patch+Nic Gum plus CMAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: CMAC | Intervention Type: DRUG; Name: Nicotine patch; Assigned to Arm(s): 2 Weeks of Nicotine Patch Only plus CMAC, 2 Weeks of Nicotine Patch Only, No CMAC, 2 Wks Nicotine Patch+Nic Gum plus CMAC, 2 Wks Nicotine Patch+Nic Gum, No CMAC, 6 Weeks of Nicotine Patch Only plus CMAC, 6 Weeks of Nicotine Patch Only, No CMAC, 6 Wks Nicotine Patch+Nic Gum plus CMAC, 6 Wks Nicotine Patch+Nic Gum, No CMAC | Intervention Type: DRUG; Name: Nicotine gum; Assigned to Arm(s): 2 Wks Nicotine Patch+Nic Gum plus CMAC, 2 Wks Nicotine Patch+Nic Gum, No CMAC, 6 Wks Nicotine Patch+Nic Gum plus CMAC, 6 Wks Nicotine Patch+Nic Gum, No CMAC | Intervention Type: BEHAVIORAL; Name: CMAC; Assigned to Arm(s): 2 Weeks of Nicotine Patch Only plus CMAC, 2 Wks Nicotine Patch+Nic Gum plus CMAC, 6 Weeks of Nicotine Patch Only plus CMAC, 6 Wks Nicotine Patch+Nic Gum plus CMAC
C: Intervention Type: DRUG; Name: varenicline (CP-526,555); Assigned to Arm(s): N/A
D: 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

Answer: B