Adherence, Motivation, Nicotine Dependence, Smoking, Smoking Cessation
Conditions
Keywords
Smoking, Smoking Cessation, Adherence, Nicotine, Motivation
Brief summary
Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.
Detailed description
Nonadherent use of smoking cessation medications is very common and highly associated with cessation failure. However, little is presently known about how to improve adherence and whether improved adherence will actually boost cessation success (i.e., its causal role is unknown). This research represents groundbreaking integration of 1) basic theory and data on tobacco dependence, adherence, and intervention mechanisms with 2) the state-of-the-art Intervention Optimization Cycle methodology. This methodology uses factorial designs to efficiently engineer and evaluate intervention components, and to develop an optimal comprehensive treatment package. Participants in Project 3 will be smokers (N = 544) visiting primary care clinics for a regular outpatient visit who, when asked, express an interest in quitting and agree to participate in a smoking cessation research study. The experiment will comprise five experimental factors (2X2X2X2X2), and participants will have a 50% chance of being assigned one of the levels of each factor. The five factors include one medication factor (medication duration: 8 vs. 26 weeks), one counseling factor (maintenance counseling vs. no maintenance counseling), and three adherence factors: 1) Cognitive Medication Adherence Counseling (C-MAC); C-MAC vs. no C-MAC; 2) electronic medication monitoring device (the Helping Hand) + Feedback vs. the medication monitoring device alone; and 3) automated adherence prompting phone calls vs. no prompting.
Interventions
DRUGShort Term Combination Nicotine Replacement Therapy (patch + gum)
IF participant smokes \>10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment. IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
DRUGLong Term Combination Nicotine Replacement Therapy (patch + gum)
IF the participant smokes \>10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment. IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
BEHAVIORALIntensive Maintenance Counseling
Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 & 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.
BEHAVIORALCognitive Medication Adherence Counseling (CAM)
Participants randomized to this condition will be given a brief (10 minute) session of CAM treatment at both Visits 1 and 2. CAM will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CAM intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.
BEHAVIORALElectronic Medication Monitoring Device (the Helping Hand) + Feedback
If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).
BEHAVIORALAutomated Adherence Prompting Phone Calls
Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication. Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 & 23.
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 | Assessed at 52 weeks after target quit day | 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 (52 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 52 Self-Reported 7-Day Point-Prevalence Abstinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Latency to Relapse | Assessed during the first 12 months post-quit after target quit day | Latency to Relapse during the first 12 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, 26Wks, Counseling, CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 13 |
| 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 17 |
| 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 14 |
| 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 19 |
| 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 16 |
| 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 19 |
| 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 15 |
| 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 15 |
| 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 22 |
| 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 20 |
| 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 17 |
| 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 16 |
| 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 17 |
| 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 19 |
| 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 18 |
| 16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 18 |
| 17, 8Wks, Counseling, CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 14 |
| 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 16 |
| 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 17 |
| 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 18 |
| 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 17 |
| 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 16 |
| 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 21 |
| 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 16 |
| 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 18 |
| 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 14 |
| 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 18 |
| 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 18 |
| 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 19 |
| 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 15 |
| 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback | 14 |
| 32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback This arm of the project will address the following question:
How effective is the following intervention?:
8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback | 18 |
| Total | 544 |
Baseline characteristics
| Characteristic | 2, 26Wks, Counseling, CAM, AutoCalls, No Feedback | 3, 26Wks, Counseling, CAM, No AutoCalls, Feedback | 4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback | 5, 26Wks, Counseling, No CAM, AutoCalls, Feedback | 6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback | 7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback | 8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback | 9, 26Wks, No Counseling, CAM, AutoCalls, Feedback | 10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback | 11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback | 12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback | 13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback | 14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback | 15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback | 16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback | 17, 8Wks, Counseling, CAM, AutoCalls, Feedback | 1, 26Wks, Counseling, CAM, AutoCalls, Feedback | 18, 8Wks, Counseling, CAM, AutoCalls, No Feedback | 19, 8Wks, Counseling, CAM, No AutoCalls, Feedback | 20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback | 21, 8Wks, Counseling, No CAM, AutoCalls, Feedback | 22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback | 23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback | 24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback | 25, 8Wks, No Counseling, CAM, AutoCalls, Feedback | 26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback | 27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback | 28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback | 29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback | 30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback | 31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback | 32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 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 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 13 Participants | 16 Participants | 15 Participants | 18 Participants | 14 Participants | 15 Participants | 18 Participants | 19 Participants | 17 Participants | 15 Participants | 17 Participants | 18 Participants | 14 Participants | 15 Participants | 10 Participants | 12 Participants | 15 Participants | 16 Participants | 16 Participants | 15 Participants | 12 Participants | 16 Participants | 16 Participants | 17 Participants | 14 Participants | 16 Participants | 17 Participants | 19 Participants | 14 Participants | 12 Participants | 16 Participants | 493 Participants |
| Age, Continuous | 43.82 years STANDARD_DEVIATION 9.87 | 39.86 years STANDARD_DEVIATION 10.54 | 49.42 years STANDARD_DEVIATION 14.25 | 48.81 years STANDARD_DEVIATION 14.61 | 48.89 years STANDARD_DEVIATION 9.72 | 47.33 years STANDARD_DEVIATION 9.83 | 43.53 years STANDARD_DEVIATION 8.32 | 51.55 years STANDARD_DEVIATION 13.51 | 46.50 years STANDARD_DEVIATION 11.04 | 44.29 years STANDARD_DEVIATION 10.71 | 46.69 years STANDARD_DEVIATION 11.44 | 46.41 years STANDARD_DEVIATION 9.56 | 44.58 years STANDARD_DEVIATION 13.68 | 49.33 years STANDARD_DEVIATION 17.49 | 50.39 years STANDARD_DEVIATION 12.56 | 49.07 years STANDARD_DEVIATION 16.28 | 45.08 years STANDARD_DEVIATION 12.37 | 47.00 years STANDARD_DEVIATION 13.11 | 42.53 years STANDARD_DEVIATION 12.86 | 45.72 years STANDARD_DEVIATION 12.91 | 47.35 years STANDARD_DEVIATION 12.8 | 51.81 years STANDARD_DEVIATION 13.97 | 48.76 years STANDARD_DEVIATION 14.45 | 39.19 years STANDARD_DEVIATION 11.64 | 45.50 years STANDARD_DEVIATION 12.71 | 41.50 years STANDARD_DEVIATION 10.71 | 42.67 years STANDARD_DEVIATION 14.2 | 45.72 years STANDARD_DEVIATION 10.6 | 39.53 years STANDARD_DEVIATION 12.25 | 45.33 years STANDARD_DEVIATION 12.69 | 47.21 years STANDARD_DEVIATION 16.61 | 46.78 years STANDARD_DEVIATION 13.12 | 46.12 years STANDARD_DEVIATION 12.76 |
| Region of Enrollment United States | 17 participants | 14 participants | 19 participants | 16 participants | 19 participants | 15 participants | 15 participants | 22 participants | 20 participants | 17 participants | 16 participants | 17 participants | 19 participants | 18 participants | 18 participants | 14 participants | 13 participants | 16 participants | 17 participants | 18 participants | 17 participants | 16 participants | 21 participants | 16 participants | 18 participants | 14 participants | 18 participants | 18 participants | 19 participants | 15 participants | 14 participants | 18 participants | 544 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 12 Participants | 11 Participants | 13 Participants | 9 Participants | 9 Participants | 12 Participants | 11 Participants | 9 Participants | 11 Participants | 11 Participants | 10 Participants | 10 Participants | 10 Participants | 8 Participants | 6 Participants | 9 Participants | 10 Participants | 10 Participants | 11 Participants | 10 Participants | 12 Participants | 10 Participants | 11 Participants | 8 Participants | 10 Participants | 10 Participants | 12 Participants | 9 Participants | 8 Participants | 11 Participants | 321 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 7 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 10 Participants | 9 Participants | 8 Participants | 5 Participants | 6 Participants | 9 Participants | 8 Participants | 8 Participants | 6 Participants | 7 Participants | 7 Participants | 7 Participants | 8 Participants | 6 Participants | 6 Participants | 9 Participants | 6 Participants | 7 Participants | 6 Participants | 8 Participants | 8 Participants | 7 Participants | 6 Participants | 6 Participants | 7 Participants | 223 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 146 / 275 | 141 / 269 |
| serious Total, serious adverse events | 10 / 275 | 6 / 269 |
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 (52 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 52 Self-Reported 7-Day Point-Prevalence Abstinence.
Time frame: Assessed at 52 weeks after target quit day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 8 Weeks of Nicotine Patch and Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 197 participants |
| 8 Weeks of Nicotine Patch and Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 72 participants |
| 26 Weeks of Nicotine Patch and Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 181 participants |
| 26 Weeks of Nicotine Patch and Nicotine Gum | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 94 participants |
| No Maintenance Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 202 participants |
| No Maintenance Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 79 participants |
| Maintenance Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 176 participants |
| Maintenance Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 87 participants |
| No Cognitive Medication Adherence Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 89 participants |
| No Cognitive Medication Adherence Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 184 participants |
| Cognitive Medication Adherence Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 77 participants |
| Cognitive Medication Adherence Counseling | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 194 participants |
| Electronic Medication Monitoring Device Without Feedback | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 86 participants |
| Electronic Medication Monitoring Device Without Feedback | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 186 participants |
| Electronic Medication Monitoring Device Plus Feedback | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 192 participants |
| Electronic Medication Monitoring Device Plus Feedback | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 80 participants |
| No Automated Adherence Prompting Phone Calls | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 198 participants |
| No Automated Adherence Prompting Phone Calls | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 76 participants |
| Automated Adherence Prompting Phone Calls | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Smoking | 180 participants |
| Automated Adherence Prompting Phone Calls | Self-Reported 7-Day Point-Prevalence Abstinence | # Participants Who Are Abstinent | 90 participants |
Comparison: The logistic regression model effects consisted of five treatment main effects and all 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., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.p-value: 0.01195% CI: [1.08, 1.821]Regression, Logistic
Comparison: The logistic regression model effects consisted of five treatment main effects and all 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 Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.p-value: 0.95695% CI: [0.769, 1.321]Regression, Logistic
Comparison: The logistic regression model effects consisted of five treatment main effects and all 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 Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.p-value: 0.88595% CI: [0.797, 1.301]Regression, Logistic
Comparison: The logistic regression model effects consisted of five treatment main effects and all 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., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.p-value: 0.20595% CI: [0.664, 1.092]Regression, Logistic
Comparison: The logistic regression model effects consisted of five treatment main effects and all 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 Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.p-value: 0.51495% CI: [0.842, 1.411]Regression, Logistic
Secondary
Latency to Relapse
Latency to Relapse during the first 12 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: Assessed during the first 12 months post-quit after target quit day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 8 Weeks of Nicotine Patch and Nicotine Gum | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 42 participants |
| 8 Weeks of Nicotine Patch and Nicotine Gum | Latency to Relapse | # Participants Who Relapsed (Smoking) | 227 participants |
| 26 Weeks of Nicotine Patch and Nicotine Gum | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 66 participants |
| 26 Weeks of Nicotine Patch and Nicotine Gum | Latency to Relapse | # Participants Who Relapsed (Smoking) | 209 participants |
| No Maintenance Counseling | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 53 participants |
| No Maintenance Counseling | Latency to Relapse | # Participants Who Relapsed (Smoking) | 228 participants |
| Maintenance Counseling | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 55 participants |
| Maintenance Counseling | Latency to Relapse | # Participants Who Relapsed (Smoking) | 208 participants |
| No Cognitive Medication Adherence Counseling | Latency to Relapse | # Participants Who Relapsed (Smoking) | 214 participants |
| No Cognitive Medication Adherence Counseling | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 59 participants |
| Cognitive Medication Adherence Counseling | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 49 participants |
| Cognitive Medication Adherence Counseling | Latency to Relapse | # Participants Who Relapsed (Smoking) | 222 participants |
| Electronic Medication Monitoring Device Without Feedback | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 49 participants |
| Electronic Medication Monitoring Device Without Feedback | Latency to Relapse | # Participants Who Relapsed (Smoking) | 225 participants |
| Electronic Medication Monitoring Device Plus Feedback | Latency to Relapse | # Participants Who Relapsed (Smoking) | 211 participants |
| Electronic Medication Monitoring Device Plus Feedback | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 59 participants |
| No Automated Adherence Prompting Phone Calls | Latency to Relapse | # Participants Who Relapsed (Smoking) | 218 participants |
| No Automated Adherence Prompting Phone Calls | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 54 participants |
| Automated Adherence Prompting Phone Calls | Latency to Relapse | # Participants Who Did Not Relapse (Not Smoking) | 54 participants |
| Automated Adherence Prompting Phone Calls | Latency to Relapse | # Participants Who Relapsed (Smoking) | 218 participants |
Comparison: The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.04595% CI: [0.822, 0.998]Regression, Cox
Comparison: The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.70595% CI: [0.892, 1.081]Regression, Cox
Comparison: The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.38295% CI: [0.948, 1.149]Regression, Cox
Comparison: The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).p-value: 0.33995% CI: [0.867, 1.05]Regression, Cox
p-value: 0.24895% CI: [0.858, 1.04]Regression, Cox