Study: NCT02564315

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine Mini-Lozenge for 11 Months
Description: Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine Mini-Lozenge for 11 Months
Description: Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine Mini-Lozenge for 11 Months
Description: Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine Mini-Lozenge for 11 Months
Description: Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Behavioral Reduction Counseling
Description: Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Behavioral Reduction Counseling
Description: Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Behavioral Reduction Counseling
Description: Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Behavioral Reduction Counseling
Description: Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Recycling Counseling
Description: Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Recycling Counseling
Description: Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Recycling Counseling
Description: Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Preparation Phase Recycling Counseling
Description: Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Preparation Phase Control Treatment
Description: Participants randomly assigned to the Preparation Phase Control Treatment condition will continue to receive the Initial Cessation usual care treatment (8 weeks of nicotine patch; two coaching sessions), but will also be told that they can receive additional treatment at no cost from the Wisconsin Tobacco Quitline (WTQL).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Supportive Counseling
Description: Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Supportive Counseling
Description: Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Supportive Counseling
Description: Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Supportive Counseling
Description: Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Skill Training Counseling
Description: Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and coping reports that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Skill Training Counseling
Description: Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and coping reports that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Skill Training Counseling
Description: Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and coping reports that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Skill Training Counseling
Description: Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and coping reports that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Brief Information
Description: Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Brief Information
Description: Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Brief Information
Description: Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Brief Information
Description: Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Brief Information
Description: Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Brief Information
Description: Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge
Description: All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).