A Phase 4 interventional study of Short Term Combination Nicotine Replacement Therapy (patch + gum) and Long Term Combination Nicotine Replacement Therapy (patch + gum) in Smoking, Smoking Cessation and Adherence, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-12-11.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
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.
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 544 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM)
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM)
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Long Term Combination Nicotine Replacement Therapy (patch + gum)
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Cognitive Medication Adherence Counseling (CAM)
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Intensive Maintenance Counseling
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Cognitive Medication Adherence Counseling (CAM)
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + Feedback · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Automated Adherence Prompting Phone Calls
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
Drug: Short Term Combination Nicotine Replacement Therapy (patch + gum) · Behavioral: Electronic Medication Monitoring Device (the Helping Hand) + 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
Drug: Short 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.
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.
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.
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.
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).
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.
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
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
| Milestone | 1, 26Wks, Counseling, CAM, AutoCalls, Feedback | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 13 | 17 | 14 | 19 | 16 | 19 | 15 | 15 | 22 | 20 | 17 | 16 | 17 | 19 | 18 | 18 | 14 | 16 | 17 | 18 | 17 | 16 | 21 | 16 | 18 | 14 | 18 | 18 | 19 | 15 | 14 | 18 |
| Completed | 10 | 13 | 13 | 15 | 14 | 18 | 12 | 13 | 19 | 19 | 16 | 14 | 14 | 15 | 17 | 16 | 13 | 16 | 15 | 15 | 14 | 16 | 17 | 13 | 16 | 14 | 15 | 16 | 14 | 12 | 12 | 17 |
| Not completed | 3 | 4 | 1 | 4 | 2 | 1 | 3 | 2 | 3 | 1 | 1 | 2 | 3 | 4 | 1 | 2 | 1 | 0 | 2 | 3 | 3 | 0 | 4 | 3 | 2 | 0 | 3 | 2 | 5 | 3 | 2 | 1 |
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
| participants | 8 Weeks of Nicotine Patch and Nicotine Gum | 26 Weeks of Nicotine Patch and Nicotine Gum | No Maintenance Counseling | Maintenance Counseling | No Cognitive Medication Adherence Counseling | Cognitive Medication Adherence Counseling | Electronic Medication Monitoring Device Without Feedback | Electronic Medication Monitoring Device Plus Feedback | No Automated Adherence Prompting Phone Calls | Automated Adherence Prompting Phone Calls |
|---|---|---|---|---|---|---|---|---|---|---|
| # Participants Who Relapsed (Smoking) | 227 | 209 | 228 | 208 | 214 | 222 | 225 | 211 | 218 | 218 |
| # Participants Who Did Not Relapse (Not Smoking) | 42 | 66 | 53 | 55 | 59 | 49 | 49 | 59 | 54 | 54 |
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.
| participants | 8 Weeks of Nicotine Patch and Nicotine Gum | 26 Weeks of Nicotine Patch and Nicotine Gum | No Maintenance Counseling | Maintenance Counseling | No Cognitive Medication Adherence Counseling | Cognitive Medication Adherence Counseling | Electronic Medication Monitoring Device Without Feedback | Electronic Medication Monitoring Device Plus Feedback | No Automated Adherence Prompting Phone Calls | Automated Adherence Prompting Phone Calls |
|---|---|---|---|---|---|---|---|---|---|---|
| # Participants Who Smoking | 197 | 181 | 202 | 176 | 184 | 194 | 186 | 192 | 198 | 180 |
| # Participants Who Are Abstinent | 72 | 94 | 79 | 87 | 89 | 77 | 86 | 80 | 76 | 90 |
Collected over AEs were reported for 8 or 26 weeks (for the duration of time when the participant was on medication.). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 26 Weeks of Nicotine Patch and Nicotine Gum | — | 10/275 (3.6%) | 146/275 (53.1%) |
| 8 Weeks of Nicotine Patch and Nicotine Gum | — | 6/269 (2.2%) | 141/269 (52.4%) |
| Event | 26 Weeks of Nicotine Patch and Nicotine Gum | 8 Weeks of Nicotine Patch and Nicotine Gum |
|---|---|---|
| CardiovascularCardiac disorders | 4/275 | 5/269 |
| GastrointestinalGastrointestinal disorders | 2/275 | 0/269 |
| Death-unknown causeGeneral disorders | 1/275 | 1/269 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 1/275 | 0/269 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 1/275 | 0/269 |
| CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/275 | 0/269 |
| Event | 26 Weeks of Nicotine Patch and Nicotine Gum | 8 Weeks of Nicotine Patch and Nicotine Gum |
|---|---|---|
| Skin RashSkin and subcutaneous tissue disorders | 63/275 | 50/269 |
| VividDreamsNervous system disorders | 44/275 | 52/269 |
| NauseaGastrointestinal disorders | 40/275 | 39/269 |
| InsomniaNervous system disorders | 29/275 | 31/269 |
| IndigestionGastrointestinal disorders | 28/275 | 28/269 |
| Itches or HivesSkin and subcutaneous tissue disorders | 28/275 | 18/269 |
| HeadacheNervous system disorders | 24/275 | 19/269 |
| DizzinessNervous system disorders | 23/275 | 19/269 |
| Mouth ProblemsGastrointestinal disorders | 17/275 | 18/269 |
| Age, Categorical(Participants) | 1, 26Wks, Counseling, CAM, AutoCalls, Feedback | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
| Between 18 and 65 years | 12 | 16 | 13 | 16 | 15 | 18 | 14 | 15 | 18 | 19 | 17 | 15 | 17 | 18 | 14 | 15 | 10 | 15 | 16 | 16 | 15 | 12 | 16 | 16 | 17 | 14 | 16 | 17 | 19 | 14 | 12 | 16 | 493 |
| >=65 years | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 0 | 4 | 1 | 0 | 1 | 0 | 1 | 4 | 3 | 3 | 1 | 1 | 2 | 2 | 4 | 5 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 2 | 2 | 49 |
| Age, Continuous(years) | 1, 26Wks, Counseling, CAM, AutoCalls, Feedback | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 45.08 ± 12.37 | 43.82 ± 9.87 | 39.86 ± 10.54 | 49.42 ± 14.25 | 48.81 ± 14.61 | 48.89 ± 9.72 | 47.33 ± 9.83 | 43.53 ± 8.32 | 51.55 ± 13.51 | 46.50 ± 11.04 | 44.29 ± 10.71 | 46.69 ± 11.44 | 46.41 ± 9.56 | 44.58 ± 13.68 | 49.33 ± 17.49 | 50.39 ± 12.56 | 49.07 ± 16.28 | 47.00 ± 13.11 | 42.53 ± 12.86 | 45.72 ± 12.91 | 47.35 ± 12.80 | 51.81 ± 13.97 | 48.76 ± 14.45 | 39.19 ± 11.64 | 45.50 ± 12.71 | 41.50 ± 10.71 | 42.67 ± 14.20 | 45.72 ± 10.60 | 39.53 ± 12.25 | 45.33 ± 12.69 | 47.21 ± 16.61 | 46.78 ± 13.12 | 46.12 ± 12.76 |
| Sex: Female, Male(Participants) | 1, 26Wks, Counseling, CAM, AutoCalls, Feedback | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 6 | 10 | 8 | 12 | 11 | 13 | 9 | 9 | 12 | 11 | 9 | 11 | 11 | 10 | 10 | 10 | 8 | 9 | 10 | 10 | 11 | 10 | 12 | 10 | 11 | 8 | 10 | 10 | 12 | 9 | 8 | 11 | 321 |
| Male | 7 | 7 | 6 | 7 | 5 | 6 | 6 | 6 | 10 | 9 | 8 | 5 | 6 | 9 | 8 | 8 | 6 | 7 | 7 | 8 | 6 | 6 | 9 | 6 | 7 | 6 | 8 | 8 | 7 | 6 | 6 | 7 | 223 |
| Region of Enrollment(participants) | 1, 26Wks, Counseling, CAM, AutoCalls, Feedback | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States | 13 | 17 | 14 | 19 | 16 | 19 | 15 | 15 | 22 | 20 | 17 | 16 | 17 | 19 | 18 | 18 | 14 | 16 | 17 | 18 | 17 | 16 | 21 | 16 | 18 | 14 | 18 | 18 | 19 | 15 | 14 | 18 | 544 |
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