Identifying Optimal Smoking Cessation Intervention Components (Cessation)
Status and phase
Completed
Phase 4
Conditions
Nicotine Dependence
Smoking
Smoking Cessation
Treatments
Drug: Pre-Quit Nicotine Gum
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Behavioral: Counseling before quit attempt
Study type
Interventional
Funder types
Other
NETWORK
NIH
Identifiers
Details and patient eligibility
About
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.
Enrollment
637 patients
Sex
All
Ages
18 to 99 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Single Blind
637 participants in 32 patient groups
1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Counseling before 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 group
Description:
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
Treatment:
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
Behavioral: Counseling before quit attempt
Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Behavioral: Counseling before quit attempt
Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Behavioral: Counseling before 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 group
Description:
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
Treatment:
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 group
Description:
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
Treatment:
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 group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person 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 group
Description:
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
Treatment:
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 group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Behavioral: Counseling before quit attempt
10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Behavioral: Counseling before quit attempt
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Behavioral: Counseling before quit attempt
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk
Experimental group
Description:
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
Treatment:
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Behavioral: Counseling before quit attempt
13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Patch
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk
Experimental group
Description:
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
Treatment:
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
Behavioral: Counseling before quit attempt
Drug: Pre-Quit Nicotine Gum
18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Behavioral: Counseling before quit attempt
Drug: Pre-Quit Nicotine Gum
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Counseling before quit attempt
Drug: Pre-Quit Nicotine Gum
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
Experimental group
Description:
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
Treatment:
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
Behavioral: Counseling before quit attempt
Drug: Pre-Quit Nicotine Gum
21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Gum
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk
Experimental group
Description:
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
Treatment:
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 group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person 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 group
Description:
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
Treatment:
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Drug: Pre-Quit Nicotine Gum
Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal In-person counseling during quit attempt
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Counseling before 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 group
Description:
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
Treatment:
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
Behavioral: Counseling before quit attempt
27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk
Experimental group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person counseling during the quit attempt
Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
Behavioral: Counseling before quit attempt
28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk
Experimental group
Description:
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
Treatment:
Behavioral: Intensive in-person counseling during the quit attempt
Behavioral: Intensive phone counseling during the quit attempt
Behavioral: Counseling before 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 group
Description:
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
Treatment:
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 group
Description:
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
Treatment:
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 group
Description:
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
Treatment:
Behavioral: Minimal phone counseling during the quit attempt
Behavioral: Intensive in-person 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 group
Description:
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
Treatment:
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
Trial contacts and locations
1
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