Identifying Optimal Smoking Cessation Intervention Components (Cessation)

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

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.

Sponsors & Collaborators

• Dean Health System

  collaborator OTHER

• Mercy Health System

  collaborator NETWORK

• Wake Forest University Health Sciences

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Megan E Piper, PhD · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

• Timothy B Baker, PhD · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• United States

Study Locations