NCT01116986

Identifying Optimal Smoking Cessation Intervention Components (Cessation)

Project 2: Identifying Optimal Smoking Cessation Intervention Components

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.

Conditions

• Smoking
• Smoking Cessation
• Nicotine Dependence

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.)
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
DRUG	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.
DRUG	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.
DRUG	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.
DRUG	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.
DRUG	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-05-05
• Last updated: 2015-12-11
• Results posted: 2015-03-17

Locations

1 site across 1 country: United States