Identifying Optimal Smoking Cessation Intervention Components (Cessation)
NCT ID: NCT01116986
Last Updated: 2015-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
637 participants
INTERVENTIONAL
2010-06-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16
This arm of the project will address the following question:
How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Interventions
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Counseling before quit attempt
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Minimal In-person counseling during quit attempt
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Intensive in-person counseling during the quit attempt
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
Minimal phone counseling during the quit attempt
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
Intensive phone counseling during the quit attempt
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Short Term Nicotine Patch + Nicotine Gum during the quit attempt
If randomized to this condition:
After the target quit day:
Patch:
IF \> 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
IF \< or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
Gum:
IF \> 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF \< or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Pre-Quit Nicotine Gum
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day.
Pre-Quit Nicotine Patch
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
If randomized to both the Prequit Patch and Prequit Gum Conditions:
Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Eligibility Criteria
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Inclusion Criteria
* Report smoking at least 5 cigarettes per day for the previous 6 months;
* Able to read and write English;
* Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
* Plans to remain in the intervention catchment area for at least 12 months;
* Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
* All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.
Exclusion Criteria
* Study candidate is pregnant, trying to get pregnant, or nursing.
* A history of psychosis or bipolar disorder
* A history of skin or allergic reactions while using a nicotine patch.
* Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
18 Years
99 Years
ALL
No
Sponsors
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Dean Health System
OTHER
Mercy Health System
NETWORK
Wake Forest University Health Sciences
OTHER
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Megan E Piper, PhD
Role: STUDY_DIRECTOR
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Timothy B Baker, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Locations
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Related Links
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Other Identifiers
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H-2009-0204
Identifier Type: -
Identifier Source: org_study_id