Cigarette Smoking, Nicotine Dependence
Conditions
Brief summary
The purpose of this study is to ascertain: 1) the rate of smoking cessation obtained using an adaptive treatment algorithm developed in previous clinical trials, in order to calculate cost-effectiveness of the treatment; 2) the relationship between genotype and response to cigarette smoking cessation treatment.
Detailed description
Previous research has shown that the initial response to nicotine patch treatment can be used to decide whether the patch alone is likely to help smokers to quit or whether alternative prescription medications may be needed to achieve smoking abstinence. This study applies the knowledge gained from this previous research to adapt the smoking cessation treatment provided to participants, based on their degree of smoking reduction during the first four weeks of nicotine patch treatment. By demonstrating effectiveness of this algorithm, this study may lead to further dissemination of the adaptive treatment strategy to other health care settings. Additionally, by gathering further information relating genomic markers to outcome, the foundation will be laid for potential practical application of this index in other settings.
Interventions
For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
DRUGnicotine patches
21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
Sponsors
Philip Morris USA, Inc.
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Duke employees who are enrolled in a Duke Health Plan and intend to remain employed at Duke for the next six months; * Dependents of Duke employees who meet the above criteria; * 18-65 years old; * Currently smoke an average of at least 10 cigarettes per day; * Willing to take Chantix or Zyban; * Express a desire to quit smoking within the next 30 days.
Exclusion criteria
* Hypertension; * Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg); * Coronary heart disease; * Lifetime history of heart attack; * Cardiac rhythm disorder (irregular heart rhythm); * Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source); * Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure); * Extensive active skin disorder; * Liver or kidney disorder (except kidney stones, gallstones); * Gastrointestinal disease other than gastroesophageal reflux or heartburn; * Active ulcers in the past 30 days; * Currently symptomatic lung disorder/disease (including but not limited to COPD, emphysema, and asthma); * Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder); * Migraine headaches that occur more frequently than once per week; * Recent, unexplained fainting spells; * Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%); * Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer); * Other major medical condition; * Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide; * Pregnant or nursing mothers; * Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD); * Current depression; * Bulimia or anorexia; * Alcohol abuse; * Significant adverse reaction to bupropion/Wellbutrin/Zyban, Chantix/Varenicline or nicotine patches in the past. * Use (within the past 30 days) of: * Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid. * Medications that are known to affect smoking cessation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation | End of study drug treatment period (11-12 weeks) | Study was terminated early due to difficulties with enrollment. No outcome measures were assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quit Success Genotype Score | After 6 month Follow-Up | Study was terminated early due to difficulties with enrollment. No outcome measures were assessed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from May 2012 until May 2013. We were only able to enter 19 of the 300 subjects into the study. We discontinued the study in July 2013 because of the recruitment difficulties.
Pre-assignment details
Of the 19 subjects who signed a consent form: 9 subjects began study participation; 7 subjects were excluded prior to receiving study drug because of medical issues and 3 subjects met other exclusion criteria and were excluded prior to receiving study drug.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline (Chantix) This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline. | 5 |
| Nicotine Patches This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches. | 2 |
| Bupropion (Zyban) and Nicotine Patches This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches. | 2 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Nicotine Patches | Bupropion (Zyban) and Nicotine Patches | Varenicline (Chantix) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 5 Participants | 9 Participants |
| Age, Continuous | 33.47 years STANDARD_DEVIATION 0.43 | 39.61 years STANDARD_DEVIATION 3.94 | 47.02 years STANDARD_DEVIATION 10.75 | 42.36 years STANDARD_DEVIATION 9.75 |
| Region of Enrollment United States | 2 participants | 2 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Time frame: End of study drug treatment period (11-12 weeks)
Secondary
Quit Success Genotype Score
Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.
Time frame: After 6 month Follow-Up
Population: Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.