Optimizing Smoking Cessation Strategies for the Prevention of Smoking in Cigarette Smokers
This phase IV trial compares different stop-smoking treatments in help cigarette smokers quit smoking. Smoking causes almost 30% of cancer-related deaths and continues to be the leading preventable cause of death and disease in the United States. While effective smoking treatments exist including non-nicotine pills, nicotine patches, and nicotine mini-lozenges, it is not yet known the best combination of these treatments, or what treatments enhance the effectiveness of others, to help smokers remain smoke-free. The purpose of this study is to find out what combination of treatment strategies is most effective and most cost-effective in helping smokers stop smoking.
Inclusion Criteria
- Age > 17 years
- Smoking > 4 cigarettes/day for the previous 6 months
- Able to read, write, and speak English
- Not currently taking bupropion or varenicline
- If currently using NRT, agreeing to use only study medication for the duration of the study
- Medically eligible to use study medications (e.g., no severe renal disease, no allergic reactions to tested agents)
- For women of childbearing potential, using an approved method of birth control during treatment
Exclusion Criteria
- Patients will be excluded if they report suicidal ideation within the last 12 months or any suicide attempts in the past 10 years
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04188873.
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.
Trial PhasePhase IV
Trial Typeprevention
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorMichael C. Fiore
- Primary IDUW20071
- Secondary IDsNCI-2021-00536, 2019-0054
- ClinicalTrials.gov IDNCT04188873