Nicotine Dependence, Smoking, Smoking Cessation
Conditions
Keywords
Smoking, Smoking Cessation, Nicotine
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.
Interventions
BEHAVIORALCounseling 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.
BEHAVIORALMinimal 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.)
BEHAVIORALIntensive 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.
BEHAVIORALMinimal 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.
BEHAVIORALIntensive 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.
DRUGLong 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.
DRUGShort 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.
DRUGPre-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.
DRUGPre-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.
DRUGPre-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
Dean Health System
Mercy Health System
Wake Forest University Health Sciences
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Abstinence | 16 weeks post-quit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Latency to Relapse | During the first 6 months post-quit | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk 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 | 24 |
| 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk 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 | 19 |
| 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk 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 | 18 |
| 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk 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 | 22 |
| 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk 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 | 24 |
| 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk 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 | 22 |
| 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk 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 | 22 |
| 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk 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 | 22 |
| 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk 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 | 20 |
| 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk 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 | 23 |
| 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk 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 | 19 |
| 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk 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 | 20 |
| 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk 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 | 17 |
| 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk 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 | 19 |
| 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk 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 | 17 |
| 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk 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 | 21 |
| 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk 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 | 16 |
| 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk 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 | 24 |
| 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk 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. | 23 |
| 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk 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 | 15 |
| 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk 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 | 24 |
| 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk 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 | 20 |
| 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk 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 | 23 |
| 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk 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 | 21 |
| 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk 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 | 18 |
| 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk 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 | 19 |
| 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk 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 | 18 |
| 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk 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 | 19 |
| 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16 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 | 17 |
| 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W 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 | 17 |
| 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W 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 | 17 |
| 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16 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 | 17 |
| Total | 637 |
Baseline characteristics
| Characteristic | 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 | 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk | 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 | 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk | 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk | 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 | 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 | 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 | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 20 Participants | 22 Participants | 22 Participants | 22 Participants | 22 Participants | 17 Participants | 22 Participants | 18 Participants | 19 Participants | 16 Participants | 19 Participants | 17 Participants | 20 Participants | 15 Participants | 24 Participants | 23 Participants | 22 Participants | 15 Participants | 23 Participants | 20 Participants | 21 Participants | 20 Participants | 18 Participants | 19 Participants | 14 Participants | 17 Participants | 15 Participants | 15 Participants | 16 Participants | 17 Participants | 607 Participants |
| Age, Continuous | 44.79 years STANDARD_DEVIATION 11.67 | 44.28 years STANDARD_DEVIATION 10.88 | 43.91 years STANDARD_DEVIATION 13.19 | 50.0 years STANDARD_DEVIATION 12.03 | 41.50 years STANDARD_DEVIATION 12.5 | 46.86 years STANDARD_DEVIATION 11.67 | 39.73 years STANDARD_DEVIATION 13.58 | 43.00 years STANDARD_DEVIATION 14.18 | 47.43 years STANDARD_DEVIATION 10.75 | 46.26 years STANDARD_DEVIATION 11.84 | 45.10 years STANDARD_DEVIATION 12.23 | 42.53 years STANDARD_DEVIATION 12.58 | 42.63 years STANDARD_DEVIATION 9.75 | 44.94 years STANDARD_DEVIATION 10.97 | 50.05 years STANDARD_DEVIATION 8.87 | 47.13 years STANDARD_DEVIATION 10.68 | 48.54 years STANDARD_DEVIATION 9.9 | 45.83 years STANDARD_DEVIATION 11.45 | 43.83 years STANDARD_DEVIATION 13.66 | 45.20 years STANDARD_DEVIATION 14.56 | 47.38 years STANDARD_DEVIATION 9.57 | 46.30 years STANDARD_DEVIATION 12.09 | 44.17 years STANDARD_DEVIATION 12.51 | 45.33 years STANDARD_DEVIATION 9.98 | 45.00 years STANDARD_DEVIATION 11.78 | 46.32 years STANDARD_DEVIATION 12.87 | 54.56 years STANDARD_DEVIATION 11.59 | 48.37 years STANDARD_DEVIATION 12.95 | 41.82 years STANDARD_DEVIATION 15.02 | 48.29 years STANDARD_DEVIATION 13.96 | 51.18 years STANDARD_DEVIATION 10 | 40.65 years STANDARD_DEVIATION 11.25 | 45.73 years STANDARD_DEVIATION 12.05 |
| Region of Enrollment United States | 19 participants | 18 participants | 22 participants | 24 participants | 22 participants | 22 participants | 22 participants | 20 participants | 23 participants | 19 participants | 20 participants | 17 participants | 19 participants | 17 participants | 21 participants | 16 participants | 24 participants | 24 participants | 23 participants | 15 participants | 24 participants | 20 participants | 23 participants | 21 participants | 18 participants | 19 participants | 18 participants | 19 participants | 17 participants | 17 participants | 17 participants | 17 participants | 637 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 12 Participants | 13 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 10 Participants | 11 Participants | 11 Participants | 10 Participants | 10 Participants | 11 Participants | 9 Participants | 12 Participants | 12 Participants | 11 Participants | 9 Participants | 13 Participants | 11 Participants | 13 Participants | 11 Participants | 10 Participants | 10 Participants | 11 Participants | 10 Participants | 8 Participants | 8 Participants | 10 Participants | 10 Participants | 348 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 10 Participants | 11 Participants | 10 Participants | 10 Participants | 10 Participants | 8 Participants | 11 Participants | 9 Participants | 9 Participants | 6 Participants | 9 Participants | 7 Participants | 10 Participants | 7 Participants | 12 Participants | 12 Participants | 12 Participants | 6 Participants | 11 Participants | 9 Participants | 10 Participants | 10 Participants | 8 Participants | 9 Participants | 7 Participants | 9 Participants | 9 Participants | 9 Participants | 7 Participants | 7 Participants | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 173 | 27 / 156 | 22 / 166 | 0 / 142 | 51 / 304 | 55 / 333 |
| serious Total, serious adverse events | 1 / 173 | 1 / 156 | 0 / 166 | 0 / 142 | 5 / 333 | 2 / 304 |
Outcome results
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.
Time frame: 16 weeks post-quit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Pre-Quit Nicotine Patch | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 100 participants |
| No Pre-Quit Nicotine Patch | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 208 participants |
| Pre-Quit Nicotine Patch | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 209 participants |
| Pre-Quit Nicotine Patch | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 120 participants |
| No Pre-Quit Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 97 participants |
| No Pre-Quit Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 201 participants |
| Pre-Quit Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 216 participants |
| Pre-Quit Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 123 participants |
| No Counseling Before the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 221 participants |
| No Counseling Before the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 99 participants |
| Counseling Before the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 121 participants |
| Counseling Before the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 196 participants |
| Minimal In-person Counseling During the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 106 participants |
| Minimal In-person Counseling During the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 217 participants |
| Intensive In-person Counseling During the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 200 participants |
| Intensive In-person Counseling During the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 114 participants |
| Minimal Phone Counseling During the Quit Attemp | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 211 participants |
| Minimal Phone Counseling During the Quit Attemp | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 106 participants |
| Intensive Phone Counseling During the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 206 participants |
| Intensive Phone Counseling During the Quit Attempt | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 114 participants |
| Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 223 participants |
| Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 110 participants |
| Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Smoking | 194 participants |
| Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Were Abstinent | 110 participants |
Comparison: The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.p-value: 0.34195% CI: [0.916, 1.29]Regression, Logistic
Comparison: The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.p-value: 0.20795% CI: [0.941, 1.325]Regression, Logistic
Comparison: The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.p-value: 0.04195% CI: [1.008, 1.42]Regression, Logistic
Comparison: The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.p-value: 0.53695% CI: [0.889, 1.254]Regression, Logistic
Comparison: The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.p-value: 0.58795% CI: [0.883, 1.246]Regression, Logistic
Comparison: The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.p-value: 0.38995% CI: [0.909, 1.278]Regression, Logistic
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.
Time frame: During the first 6 months post-quit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No Pre-Quit Nicotine Patch | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 73 participants |
| No Pre-Quit Nicotine Patch | Latency to Relapse | # Participants Who Relapsed (Smoking) | 235 participants |
| Pre-Quit Nicotine Patch | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 86 participants |
| Pre-Quit Nicotine Patch | Latency to Relapse | # Participants Who Relapsed (Smoking) | 243 participants |
| No Pre-Quit Nicotine Gum | Latency to Relapse | # Participants Who Relapsed (Smoking) | 228 participants |
| No Pre-Quit Nicotine Gum | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 70 participants |
| Pre-Quit Nicotine Gum | Latency to Relapse | # Participants Who Relapsed (Smoking) | 250 participants |
| Pre-Quit Nicotine Gum | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 89 participants |
| No Counseling Before the Quit Attempt | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 77 participants |
| No Counseling Before the Quit Attempt | Latency to Relapse | # Participants Who Relapsed (Smoking) | 243 participants |
| Counseling Before the Quit Attempt | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 82 participants |
| Counseling Before the Quit Attempt | Latency to Relapse | # Participants Who Relapsed (Smoking) | 235 participants |
| Minimal In-person Counseling During the Quit Attempt | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 77 participants |
| Minimal In-person Counseling During the Quit Attempt | Latency to Relapse | # Participants Who Relapsed (Smoking) | 246 participants |
| Intensive In-person Counseling During the Quit Attempt | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 82 participants |
| Intensive In-person Counseling During the Quit Attempt | Latency to Relapse | # Participants Who Relapsed (Smoking) | 232 participants |
| Minimal Phone Counseling During the Quit Attemp | Latency to Relapse | # Participants Who Relapsed (Smoking) | 242 participants |
| Minimal Phone Counseling During the Quit Attemp | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 75 participants |
| Intensive Phone Counseling During the Quit Attempt | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 84 participants |
| Intensive Phone Counseling During the Quit Attempt | Latency to Relapse | # Participants Who Relapsed (Smoking) | 236 participants |
| Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 87 participants |
| Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum | Latency to Relapse | # Participants Who Relapsed (Smoking) | 246 participants |
| Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum | Latency to Relapse | # Participants Who Relapsed (Smoking) | 232 participants |
| Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 72 participants |
Comparison: The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.31295% CI: [0.871, 1.045]Regression, Cox
Comparison: The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.66495% CI: [0.894, 1.074]Regression, Cox
Comparison: The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.81495% CI: [0.903, 1.084]Regression, Cox
Comparison: The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.09395% CI: [0.844, 1.013]Regression, Cox
Comparison: The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.71695% CI: [0.898, 1.077]Regression, Cox
Comparison: The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.51195% CI: [0.941, 1.13]Regression, Cox