Identifying Optimal Smoking Cessation Intervention Components (Cessation)

NCT01116986 | Completed Phase 4 Results DMC

• 2 other identifiers: H-2009-02049P50CA143188
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Smoking; Smoking Cessation; Nicotine

Outcome Measures

Primary Outcomes (1)

• Self-Reported 7-Day Point-Prevalence Abstinence

  Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome.

  16 weeks post-quit

Secondary Outcomes (1)

• Latency to Relapse

  During the first 6 months post-quit

Study Arms (32)

1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum

9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch

10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch

11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch

12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch

13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch

14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch

15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Patch

16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Patch

17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum

18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum

19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum

20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum

21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum

22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum

23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt; Drug: Pre-Quit Nicotine Gum

24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt; Drug: Pre-Quit Nicotine Gum

25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk

EXPERIMENTAL

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

Behavioral: Counseling before quit attempt; Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W

EXPERIMENTAL

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

Behavioral: Minimal In-person counseling during quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Minimal phone counseling during the quit attempt; Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt

32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16

EXPERIMENTAL

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

Behavioral: Intensive in-person counseling during the quit attempt; Behavioral: Intensive phone counseling during the quit attempt; Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt

Interventions

Counseling before quit attempt BEHAVIORAL

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.

1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk; 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk; 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk; 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk; 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk; 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk; 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk; 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk; 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk; 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk; 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk; 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk; 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk; 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk; 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk; 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

Minimal In-person counseling during quit attempt BEHAVIORAL

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.)

1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk; 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk; 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk; 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk; 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk; 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk; 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk; 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16; 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W; 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk; 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk; 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

Intensive in-person counseling during the quit attempt BEHAVIORAL

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.

11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk; 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk; 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk; 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk; 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk; 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk; 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk; 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W; 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16; 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk; 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk; 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

Minimal phone counseling during the quit attempt BEHAVIORAL

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.

1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk; 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk; 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk; 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk; 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk; 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk; 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16; 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk; 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W; 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk; 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk; 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

Intensive phone counseling during the quit attempt BEHAVIORAL

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.

10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk; 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk; 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk; 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk; 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk; 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk; 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk; 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W; 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16; 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk; 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk; 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt DRUG

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.

12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk; 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk; 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk; 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk; 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk; 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk; 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16; 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk; 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16; 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk; 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk; 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

Short Term Nicotine Patch + Nicotine Gum during the quit attempt DRUG

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.

1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk; 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk; 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk; 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk; 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk; 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk; 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk; 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W; 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W; 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk; 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk; 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk

Pre-Quit Nicotine Gum DRUG

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.

17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk; 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk; 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk; 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk; 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk

Pre-Quit Nicotine Patch DRUG

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; 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk; 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk; 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk; 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk; 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk; 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk; 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk

Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum DRUG

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.

1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk; 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk; 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk; 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk; 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk; 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk; 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk; 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Dean Health System: collaborator
• Mercy Health System: collaborator
• Wake Forest University Health Sciences: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Madison, Wisconsin, 53711, United States

Location

Related Links

• University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Stevens Smith
• Organization: UWisconsin

sss@ctri.medicine.wisc.edu

608-262-7563

Study Officials

• Megan E Piper, PhD

  University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

  STUDY DIRECTOR

• Timothy B Baker, PhD

  University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 5, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 11, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-11

Locations

US (1)