Optimizing Smoking Cessation Strategies for the Prevention of Smoking in Cigarette Smokers

PRIMARY OBJECTIVES:

I. To determine which smoking cessation intervention components, and combinations of components, significantly improve smoking abstinence and cost-effectiveness based on main and interactive effects on 12-month biochemically confirmed abstinence.

II. To identify two optimized smoking cessation treatments: one for varenicline and one for combination nicotine replacement therapy (C-NRT).

SECONDARY OBJECTIVES:

I. To determine whether person factors (e.g., sex, dependence, psychiatric history) moderate response to different treatment strategies.

II. To determine the main and interactive effects of the cessation interventions on cost-effectiveness.

OUTLINE: Patients are randomized to 1 of 16 arms.

ARM I (12-WEEK VARENICLINE WITH MINIMAL COUNSELING): Starting 1 week prior to their target quit date (TQD), participants receive varenicline orally (PO) once daily (QD) on days 1-3, twice daily (BID) on day 4 of week 1 through 11 weeks post-TQD. Participants also participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mobile health (mHealth) resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM II (12-WEEK VARENICLINE WITH 4-WEEK PREPARATION VARENICLINE AND MINIMAL COUNSELING): Starting 4 weeks prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 11 weeks post-TQD. Participants also participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM III (24-WEEK VARENICLINE WITH MINIMAL COUNSELING): Starting 1 week prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 23 weeks post-TQD. Participants also participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM IV (24-WEEK VARENICLINE WITH 4-WEEK PREPARATION VARENICLINE AND MINIMAL COUNSELING): Starting 4 weeks prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 23 weeks post-TQD. Participants also participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM V (12-WEEK VARENICLINE WITH INTENSIVE COUNSELING): Starting 1 week prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 11 weeks post-TQD. Participants also participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM VI (12-WEEK VARENICLINE WITH 4-WEEK PREPARATION VARENICLINE AND INTENSIVE COUNSELING): Starting 4 weeks prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 11 weeks post-TQD. Participants also participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM VII (24-WEEK VARENICLINE WITH INTENSIVE COUNSELING): Starting 1 week prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 23 weeks post-TQD. Participants also participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM VIII (24-WEEK VARENICLINE WITH 4-WEEK PREPARATION VARENICLINE AND INTENSIVE COUNSELING): Starting 4 weeks prior to their TQD, participants receive varenicline PO QD on days 1-3, PO BID on day 4 of week 1 through 23 weeks post-TQD. Participants also participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM IX (12-WEEK C-NRT WITH MINIMAL COUNSELING): Starting on their quit date, participants who smoke > 10 cigarettes per day receive high dose nicotine patches for weeks 1-8, lower dose patches for weeks 9-10, and lowest dose patches for weeks 11-12. Participants who smoke 5-10 cigarettes per day receive lower dose nicotine patch during weeks 1-10 and the lowest dose during weeks 11-12. Participants also receive nicotine mini-lozenges. Participants participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM X (12-WEEK C-NRT WITH 4-WEEK PREPARATION C-NRT AND MINIMAL COUNSELING): Starting 4 weeks prior to their TQD, participants who smoke > 10 cigarettes per day receive lower dose nicotine patches, then stating on TQD receive high dose nicotine patch for weeks 1-8, lower dose for weeks 9-10, and lowest dose patches for weeks 11-12. Participants who smoke 5-10 cigarettes per day receive lower dose nicotine patch during weeks 1-10 and the lowest dose during weeks 11-12. Participants also receive nicotine mini-lozenges. Participants participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM XI (24-WEEK C-NRT WITH MINIMAL COUNSELING): Starting on their TQD, participants who smoke > 10 cigarettes per day receive high dose nicotine patches for weeks 1-20, lower dose patches for weeks 21-22, and lowest dose patches for weeks 23-24. Participants who smoke 5-10 cigarettes per day receive lower dose nicotine patch during weeks 1-22 and the lowest dose during weeks 23-24. Participants also receive nicotine mini-lozenges. Participants participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM XII (24-WEEK C-NRT WITH 4-WEEK PREPARATION C-NRT AND MINIMAL COUNSELING): Starting 4 weeks prior to their TQD, participants who smoke > 10 cigarettes per day receive lower dose nicotine patches, then starting on their TQD receive high dose nicotine patches for weeks 1-20, lower dose patches for weeks 21-22 and lowest dose patches for weeks 23-24. Participants also receive nicotine mini-lozenges. Participants participate in a phone or video counseling session over 10-20 minutes to promote engagement with free mHealth resources 1 week prior to the TQD, and participate in follow-up phone or video sessions over 10-20 minutes during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.

ARM XIII (12-WEEK C-NRT WITH INTENSIVE COUNSELING): Starting on their quit date, participants who smoke > 10 cigarettes per day receive high dose nicotine patches for weeks 1-8, lower dose patches for weeks 9-10, and lowest dose patches for weeks 11-12. Participants who smoke 5-10 cigarettes per day receive lower dose nicotine patch during weeks 1-10 and the lowest dose during weeks 11-12. Participants also participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM XIV (12-WEEK C-NRT WITH 4-WEEK PREPARATION C-N-RT AND INTENSIVE COUNSELING): Starting 4 weeks prior to their TQD, participants who smoke > 10 cigarettes per day receive lower dose nicotine patches, then stating on TQD receive high dose nicotine patch during weeks 1-8, lower dose during weeks 9-10, and then lowest dose during weeks 11-12. Participants who smoke 5-10 cigarettes per day receive lower dose nicotine patch during weeks 1-10 and the lowest dose during weeks 11-12. Participants also receive nicotine mini-lozenges. Participants participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM XV (24-WEEK C-NRT WITH INTENSIVE COUNSELING): Starting on their TQD, participants who smoke > 10 cigarettes per day receive high dose nicotine patch during weeks 1-20, lower dose during weeks 21-22, and then lowest dose during weeks 23-24. Participants who smoke 5-10 cigarettes per day receive lower dose nicotine patch during weeks 1-22 and the lowest dose during weeks 23-24. Participants also receive nicotine mini-lozenges. Participants participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.

ARM XVI (24-WEEK C-NRT WITH 4-WEEK PREPARATION C-NRT AND INTENSIVE COUNSELING): Starting 4 weeks prior to their TQD, participants who smoke > 10 cigarettes per day receive lower dose nicotine patches, then starting on their TQD receive high dose nicotine patches during weeks 1-20, lower dose patches for weeks 21-22 and lowest patches for weeks 23-24. Participants also receive nicotine mini-lozenges. Participants also participate in 4 phone or video counseling sessions over 15-20 minutes each designed to produce intra-treatment support and skill training, consistent with the PHS Clinical Practice Guideline prior to the TQD, during the first week post-TQD and during weeks 2 and 4 post-TQD.