Identifying Optimal Smoking Cessation Intervention Components (Cessation)

Smoking Cessation Clinical Trial

— Cessation  

Official title:

Project 2: Identifying Optimal Smoking Cessation Intervention Components

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116986
• Other study ID #: H-2009-0204
• Secondary ID: 9P50CA143188
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2010
• Last updated: November 12, 2015
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Smoking Cessation

Intervention

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.
• 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.

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (5)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Aurora Health Care, Dean Health System, Mercy Health System, Wisconsin, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Latency to Relapse	Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.	During the first 6 months post-quit	No

External Links

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