Study: NCT06474299

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Varenicline
Description: 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Varenicline
Description: 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Varenicline
Description: 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Varenicline
Description: 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine patch
Description: Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine patch
Description: Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine patch
Description: Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine patch
Description: Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Dual Focused Cessation Counseling
Description: Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Dual Focused Cessation Counseling
Description: Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Dual Focused Cessation Counseling
Description: Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Dual Focused Cessation Counseling
Description: Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Smoking Focused Cessation Counseling
Description: Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Smoking Focused Cessation Counseling
Description: Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Smoking Focused Cessation Counseling
Description: Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Smoking Focused Cessation Counseling
Description: Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 1 Session
Description: Participants assigned to one session will complete a single, 15-20 minute, in-person session at Visit 2 (1 week pre-TQD).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 1 Session
Description: Participants assigned to one session will complete a single, 15-20 minute, in-person session at Visit 2 (1 week pre-TQD).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 1 Session
Description: Participants assigned to one session will complete a single, 15-20 minute, in-person session at Visit 2 (1 week pre-TQD).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 1 Session
Description: Participants assigned to one session will complete a single, 15-20 minute, in-person session at Visit 2 (1 week pre-TQD).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 4 Sessions
Description: Participants assigned to intensive counseling will have four, 15-20-minute sessions, one in-person at Visit 2 and then 3 phone sessions: 1 day post-TQD and Weeks 1 and 2.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 4 Sessions
Description: Participants assigned to intensive counseling will have four, 15-20-minute sessions, one in-person at Visit 2 and then 3 phone sessions: 1 day post-TQD and Weeks 1 and 2.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 4 Sessions
Description: Participants assigned to intensive counseling will have four, 15-20-minute sessions, one in-person at Visit 2 and then 3 phone sessions: 1 day post-TQD and Weeks 1 and 2.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Counseling Intensity: 4 Sessions
Description: Participants assigned to intensive counseling will have four, 15-20-minute sessions, one in-person at Visit 2 and then 3 phone sessions: 1 day post-TQD and Weeks 1 and 2.