Study: NCT04199117

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Varenicline
Description: Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Combination nicotine patch and nicotine mini-lozenge treatment
Description: Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Monetary incentives for initiating treatment
Description: Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated tailored outreach
Description: Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Care management
Description: Participants randomized to this intervention will receive 5 live, proactive phone calls lasting 10-15 minutes from as assigned Tobacco Care Manager who will provide manualized support and motivational encouragement, discuss available treatment options, and inform the participant how to initiate treatment when ready to quit.