Smoking Cessation
Conditions
Keywords
Smoking cessation, Counseling, Genetics and Genomics
Brief summary
The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.
Detailed description
The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects. The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT \[patch and lozenge\], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.
Interventions
DRUGCombination NRT (Nicotine patch, Nicotine lozenge)
DRUGVarenicline
DRUGPlacebo
BEHAVIORALIntensive smoking counseling
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult (≥21 years of age), seeking treatment for smoking cessation. 2. Able to speak English, 3. Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm 4. Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months.
Exclusion criteria
1. Pregnancy or breast feeding, 2. Active use or recent use (\< or equal to 1 month) of medication or e-cigarettes for nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in the prior month, 3. Allergy to nicotine patch, lozenge, or varenicline, 4. Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only), 5. Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months, 6. Current heavy alcohol consumption (≥6 drinks/day, 6 days/week), 7. Active psychosis or poorly controlled depression within the past 6 months, 8. Any prior suicide attempt or suicidal ideation within the past 6 months, 9. End stage renal disease with hemodialysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Quit Rate | Week 12 | The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence | 12 weeks (with first 1 week initial grace period) | The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment. |
| 7-day Point Prevalence Quit Rate | Week 24 | The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence. |
| Number of Days to Lapse | Assessed from the target quit day through 52 weeks | * The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff). * Participants who did not lapse by the end of the 52 weeks and participants who had missing information on lapse are not included in the overall number of participants analyzed |
| Number of Days to Relapse | Assessed from the target quit day through 52 weeks | * The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking. * Participants who did not relapse by the end of the 52 weeks and participants who had missing information on relapse are not included in the overall number of participants analyzed |
| Side Effects | Pre-quit week to Week 12 | All reported side effects (occurring\>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use. |
| Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 0-52 Weeks | -The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment. |
| Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 0-52 Weeks | The definition of this measure requires self-reported cigarettes per day. |
| Medication Adherence | Pre-quit week to Week 12 | Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12 |
| Withdrawal | Pre-quit, quit, week 1, week 2, and week 4 | * Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items. * Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal. * The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores. |
| Initial Cessation | Assessed for the first seven days after the target quit date | Defined as at least 1 day of abstinence during the first 7 days after the target quit day. |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 05/20/2015 and closed to participant enrollment on 07/23/2018.
Pre-assignment details
-The study consented 894 participants and 72 were excluded after consenting due to no longer wanting to participate or not meeting all the eligibility criteria prior to randomization. The 72 were not considered enrolled in the study per the policy of the institution.
Participants by arm
| Arm | Count |
|---|---|
| Combination NRT and Counseling Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. | 275 |
| Varenicline (Chantix) and Counseling Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment. | 274 |
| Placebo Medicine and Counseling Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment. | 273 |
| Total | 822 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 19 | 18 | 21 |
Baseline characteristics
| Characteristic | Combination NRT and Counseling | Varenicline (Chantix) and Counseling | Placebo Medicine and Counseling | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 12 Participants | 15 Participants | 41 Participants |
| Age, Categorical Between 18 and 65 years | 261 Participants | 262 Participants | 258 Participants | 781 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 11.2 | 46.6 years STANDARD_DEVIATION 11 | 46.6 years STANDARD_DEVIATION 11.5 | 46.5 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 271 Participants | 265 Participants | 268 Participants | 804 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 97 Participants | 91 Participants | 82 Participants | 270 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) White | 168 Participants | 169 Participants | 179 Participants | 516 Participants |
| Region of Enrollment United States | 275 participants | 274 participants | 273 participants | 822 participants |
| Sex: Female, Male Female | 144 Participants | 144 Participants | 161 Participants | 449 Participants |
| Sex: Female, Male Male | 131 Participants | 130 Participants | 112 Participants | 373 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 275 | 2 / 274 | 4 / 273 |
| other Total, other adverse events | 193 / 275 | 204 / 274 | 175 / 273 |
| serious Total, serious adverse events | 23 / 275 | 17 / 274 | 27 / 273 |
Outcome results
Primary
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combination NRT and Counseling | 7-day Point Prevalence Quit Rate | 55 Participants |
| Varenicline (Chantix) and Counseling | 7-day Point Prevalence Quit Rate | 70 Participants |
| Placebo Medicine and Counseling | 7-day Point Prevalence Quit Rate | 24 Participants |
Secondary
7-day Point Prevalence Quit Rate
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Time frame: Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combination NRT and Counseling | 7-day Point Prevalence Quit Rate | 37 Participants |
| Varenicline (Chantix) and Counseling | 7-day Point Prevalence Quit Rate | 56 Participants |
| Placebo Medicine and Counseling | 7-day Point Prevalence Quit Rate | 25 Participants |
Secondary
Continuous Abstinence
The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment.
Time frame: 12 weeks (with first 1 week initial grace period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combination NRT and Counseling | Continuous Abstinence | 43 Participants |
| Varenicline (Chantix) and Counseling | Continuous Abstinence | 46 Participants |
| Placebo Medicine and Counseling | Continuous Abstinence | 21 Participants |
Secondary
Initial Cessation
Defined as at least 1 day of abstinence during the first 7 days after the target quit day.
Time frame: Assessed for the first seven days after the target quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combination NRT and Counseling | Initial Cessation | 217 Participants |
| Varenicline (Chantix) and Counseling | Initial Cessation | 186 Participants |
| Placebo Medicine and Counseling | Initial Cessation | 172 Participants |
Secondary
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
-The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Time frame: 0-52 Weeks
Population: Participants who had missing data are not included in the number of participants analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 0 weeks - Abstinence | 5 Participants |
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 26 week - Abstinence | 75 Participants |
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 12 week - Abstinence | 81 Participants |
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 1 week - Abstinence | 91 Participants |
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 52 week - Abstinence | 68 Participants |
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 2 week - Abstinence | 119 Participants |
| Combination NRT and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 4 week - Abstinence | 112 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 26 week - Abstinence | 82 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 4 week - Abstinence | 114 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 2 week - Abstinence | 105 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 12 week - Abstinence | 88 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 52 week - Abstinence | 77 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 1 week - Abstinence | 94 Participants |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 0 weeks - Abstinence | 3 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 4 week - Abstinence | 74 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 0 weeks - Abstinence | 0 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 1 week - Abstinence | 70 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 2 week - Abstinence | 70 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 12 week - Abstinence | 49 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 26 week - Abstinence | 49 Participants |
| Placebo Medicine and Counseling | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 52 week - Abstinence | 43 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 2 week - Abstinence | 294 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 52 week - Abstinence | 188 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 26 week - Abstinence | 206 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 1 week - Abstinence | 255 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 0 weeks - Abstinence | 8 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 12 week - Abstinence | 218 Participants |
| 3 Arms Combined | Longitudinal Models of Abstinence Outcomes Across Multiple Time Points | 4 week - Abstinence | 300 Participants |
Secondary
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
The definition of this measure requires self-reported cigarettes per day.
Time frame: 0-52 Weeks
Population: Participants who had missing data are not included in the number of participants analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 12 week | 6.38 cigarettes per day | Standard Error 0.53 |
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 4 week | 4.08 cigarettes per day | Standard Error 0.43 |
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 2 week | 3.43 cigarettes per day | Standard Error 0.39 |
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 52 week | 7.67 cigarettes per day | Standard Error 0.59 |
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 26 week | 7.68 cigarettes per day | Standard Error 0.58 |
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 1 week | 3.06 cigarettes per day | Standard Error 0.4 |
| Combination NRT and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 0 week | 2.50 cigarettes per day | Standard Error 0.38 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 4 week | 3.63 cigarettes per day | Standard Error 0.41 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 0 week | 2.95 cigarettes per day | Standard Error 0.32 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 1 week | 3.18 cigarettes per day | Standard Error 0.34 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 2 week | 3.08 cigarettes per day | Standard Error 0.35 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 12 week | 5.75 cigarettes per day | Standard Error 0.5 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 26 week | 7.09 cigarettes per day | Standard Error 0.53 |
| Varenicline (Chantix) and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 52 week | 7.76 cigarettes per day | Standard Error 0.57 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 1 week | 4.46 cigarettes per day | Standard Error 0.37 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 4 week | 5.79 cigarettes per day | Standard Error 0.43 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 12 week | 8.33 cigarettes per day | Standard Error 0.52 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 52 week | 8.98 cigarettes per day | Standard Error 0.55 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 26 week | 9.38 cigarettes per day | Standard Error 0.57 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 0 week | 3.74 cigarettes per day | Standard Error 0.38 |
| Placebo Medicine and Counseling | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 2 week | 5.00 cigarettes per day | Standard Error 0.41 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 2 week | 3.83 cigarettes per day | Standard Error 0.22 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 1 week | 3.56 cigarettes per day | Standard Error 0.22 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 4 week | 4.49 cigarettes per day | Standard Error 0.25 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 52 week | 8.12 cigarettes per day | Standard Error 0.33 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 26 week | 8.03 cigarettes per day | Standard Error 0.32 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 12 week | 3.50 cigarettes per day | Standard Error 0.3 |
| 3 Arms Combined | Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points. | 0 week | 3.06 cigarettes per day | Standard Error 0.21 |
Secondary
Medication Adherence
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12
Time frame: Pre-quit week to Week 12
Population: Not all participants were evaluable for this outcome measure due to data not being available. Also the Varenicline (Chantix) and Counseling Arm did not receive the lozenge or the patch. The Combination NRT and Counseling Arm did not receive Varenicline (Chantix)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination NRT and Counseling | Medication Adherence | Patch | 0.65 proportion of expected medication taken | Standard Deviation 0.34 |
| Combination NRT and Counseling | Medication Adherence | Lozenge | 0.57 proportion of expected medication taken | Standard Deviation 0.39 |
| Varenicline (Chantix) and Counseling | Medication Adherence | Varenicline (Chantix) | 0.67 proportion of expected medication taken | Standard Deviation 0.32 |
| Placebo Medicine and Counseling | Medication Adherence | Patch | 0.57 proportion of expected medication taken | Standard Deviation 0.36 |
| Placebo Medicine and Counseling | Medication Adherence | Lozenge | 0.57 proportion of expected medication taken | Standard Deviation 0.38 |
| Placebo Medicine and Counseling | Medication Adherence | Varenicline (Chantix) | 0.70 proportion of expected medication taken | Standard Deviation 0.35 |
Secondary
Number of Days to Lapse
* The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff). * Participants who did not lapse by the end of the 52 weeks and participants who had missing information on lapse are not included in the overall number of participants analyzed
Time frame: Assessed from the target quit day through 52 weeks
Population: 26 participants in Combination NRT \& Counseling, 19 participants in Varenicline (Chantix) \& Counseling, \& 16 participants in Placebo Medicine \& Counseling did not lapse by the end of the 52 weeks. 4 participants in Combination NRT \& Counseling, 9 participants in Varenicline (Chantix) \& Counseling, \& 5 participants had missing information on lapse.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination NRT and Counseling | Number of Days to Lapse | 16.78 days | Standard Error 2.48 |
| Varenicline (Chantix) and Counseling | Number of Days to Lapse | 20.47 days | Standard Error 3.22 |
| Placebo Medicine and Counseling | Number of Days to Lapse | 11.85 days | Standard Error 2.07 |
| 3 Arms Combined | Number of Days to Lapse | 16.33 days | Standard Error 1.52 |
Secondary
Number of Days to Relapse
* The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking. * Participants who did not relapse by the end of the 52 weeks and participants who had missing information on relapse are not included in the overall number of participants analyzed
Time frame: Assessed from the target quit day through 52 weeks
Population: 76 participants in Combination NRT \& Counseling, 66 participants in Varenicline (Chantix) \& Counseling, \& 51 participants in Placebo Medicine \& Counseling did not relapse by the end of 52 weeks. 4 participants in Combination NRT \& Counseling, 9 participants in Varenicline (Chantix) \& Counseling, \& 5 participants had missing information on relapse
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination NRT and Counseling | Number of Days to Relapse | 44.83 days | Standard Error 4.25 |
| Varenicline (Chantix) and Counseling | Number of Days to Relapse | 45.01 days | Standard Error 5.04 |
| Placebo Medicine and Counseling | Number of Days to Relapse | 28.87 days | Standard Error 3.75 |
| 3 Arms Combined | Number of Days to Relapse | 39.22 days | Standard Error 2.53 |
Secondary
Side Effects
All reported side effects (occurring\>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use.
Time frame: Pre-quit week to Week 12
Population: Not all participants were evaluable for this outcome measure due to data not being available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combination NRT and Counseling | Side Effects | Nausea | 53 Participants |
| Combination NRT and Counseling | Side Effects | Headache | 81 Participants |
| Combination NRT and Counseling | Side Effects | Racing Heart | 27 Participants |
| Combination NRT and Counseling | Side Effects | Sleep Disturbance | 49 Participants |
| Combination NRT and Counseling | Side Effects | Vomiting | 28 Participants |
| Varenicline (Chantix) and Counseling | Side Effects | Sleep Disturbance | 55 Participants |
| Varenicline (Chantix) and Counseling | Side Effects | Nausea | 92 Participants |
| Varenicline (Chantix) and Counseling | Side Effects | Vomiting | 36 Participants |
| Varenicline (Chantix) and Counseling | Side Effects | Racing Heart | 24 Participants |
| Varenicline (Chantix) and Counseling | Side Effects | Headache | 81 Participants |
| Placebo Medicine and Counseling | Side Effects | Vomiting | 27 Participants |
| Placebo Medicine and Counseling | Side Effects | Sleep Disturbance | 42 Participants |
| Placebo Medicine and Counseling | Side Effects | Headache | 71 Participants |
| Placebo Medicine and Counseling | Side Effects | Nausea | 59 Participants |
| Placebo Medicine and Counseling | Side Effects | Racing Heart | 17 Participants |
Secondary
Withdrawal
* Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items. * Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal. * The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores.
Time frame: Pre-quit, quit, week 1, week 2, and week 4
Population: Not all participants were evaluable for this outcome measure due to data not being available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination NRT and Counseling | Withdrawal | Anxiety | 1.69 score on a scale | Standard Deviation 0.79 |
| Combination NRT and Counseling | Withdrawal | Hunger | 2.11 score on a scale | Standard Deviation 0.84 |
| Combination NRT and Counseling | Withdrawal | Craving | 2.29 score on a scale | Standard Deviation 0.85 |
| Combination NRT and Counseling | Withdrawal | Anger | 1.33 score on a scale | Standard Deviation 0.75 |
| Combination NRT and Counseling | Withdrawal | Sleep | 1.49 score on a scale | Standard Deviation 0.82 |
| Combination NRT and Counseling | Withdrawal | Sadness | 1.01 score on a scale | Standard Deviation 0.63 |
| Combination NRT and Counseling | Withdrawal | Concentration | 1.28 score on a scale | Standard Deviation 0.64 |
| Varenicline (Chantix) and Counseling | Withdrawal | Craving | 2.20 score on a scale | Standard Deviation 0.86 |
| Varenicline (Chantix) and Counseling | Withdrawal | Anger | 1.49 score on a scale | Standard Deviation 0.81 |
| Varenicline (Chantix) and Counseling | Withdrawal | Anxiety | 1.81 score on a scale | Standard Deviation 0.9 |
| Varenicline (Chantix) and Counseling | Withdrawal | Concentration | 1.48 score on a scale | Standard Deviation 0.76 |
| Varenicline (Chantix) and Counseling | Withdrawal | Hunger | 2.28 score on a scale | Standard Deviation 0.8 |
| Varenicline (Chantix) and Counseling | Withdrawal | Sadness | 1.11 score on a scale | Standard Deviation 0.69 |
| Varenicline (Chantix) and Counseling | Withdrawal | Sleep | 1.70 score on a scale | Standard Deviation 0.89 |
| Placebo Medicine and Counseling | Withdrawal | Hunger | 2.17 score on a scale | Standard Deviation 0.79 |
| Placebo Medicine and Counseling | Withdrawal | Anxiety | 1.82 score on a scale | Standard Deviation 0.83 |
| Placebo Medicine and Counseling | Withdrawal | Sleep | 1.54 score on a scale | Standard Deviation 0.92 |
| Placebo Medicine and Counseling | Withdrawal | Sadness | 1.11 score on a scale | Standard Deviation 0.61 |
| Placebo Medicine and Counseling | Withdrawal | Craving | 2.50 score on a scale | Standard Deviation 0.83 |
| Placebo Medicine and Counseling | Withdrawal | Concentration | 1.42 score on a scale | Standard Deviation 0.76 |
| Placebo Medicine and Counseling | Withdrawal | Anger | 1.47 score on a scale | Standard Deviation 0.79 |