Clinical trial NCT01116986: Identifying Optimal Smoking Cessation Intervention Components (Cessation)
Official title: Project 2: Identifying Optimal Smoking Cessation Intervention Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Smoking Cessation
Nicotine Dependence
Keywords: Smoking
Smoking Cessation
Nicotine
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Dean Health System
name: Mercy Health System
name: Wake Forest University Health Sciences
name: National Cancer Institute (NCI)
First posted: 2010-05-05
Enrollment: 637
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Self-Reported 7-Day Point-Prevalence Abstinence
timeFrame: 16 weeks post-quit
Secondary outcomes:
measure: Latency to Relapse
timeFrame: During the first 6 months post-quit
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Megan E Piper, PhD
role: STUDY_DIRECTOR
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Timothy B Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: