Tobacco Dependence
Conditions
Brief summary
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.
Detailed description
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.
Interventions
DRUGnicotine patch
Decreasing dosages from 21 to 7 mg over 12 week period
DRUGnicotine lozenge
4 mg nicotine lozenge: dosage according to package directions for 16 weeks
DRUGbupropion
dosage according to prescription directions: 12 weeks
DRUGpatch + lozenge
dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
Sponsors
National Institute on Drug Abuse (NIDA)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO \> 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments, Aurora participating clinic patient
Exclusion criteria
* Uncontrolled hypertension (systolic \>180mm Hg or diastolic \>110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Month Self-reported Abstinence From Smoking | 6 months | Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview) |
Countries
United States
Participant flow
Recruitment details
Participants were 1346 smokers recruited in 12 Aurora Health Care primary care clinics in eastern Wisconsin from October 2005 through May 2007.
Pre-assignment details
Primary inclusion criteria included (1) 18 years or older; (2) 10 or more cigarettes per day (CPD) for the past 6 months; (3) motivated to quit smoking; and (4) if female, willing to use an acceptable contraception while using the study medication.
Participants by arm
| Arm | Count |
|---|---|
| Patch | 282 |
| Nicotine Lozenge | 261 |
| Bupropion | 256 |
| Patch + Lozenge | 279 |
| Buproion + Lozenge | 268 |
| Total | 1,346 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 4 | 1 | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 28 | 27 | 32 | 16 | 19 |
Baseline characteristics
| Characteristic | Patch | Nicotine Lozenge | Bupropion | Patch + Lozenge | Buproion + Lozenge | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 12.4 | 42.9 years STANDARD_DEVIATION 11.7 | 44 years STANDARD_DEVIATION 11.6 | 44.8 years STANDARD_DEVIATION 12.4 | 45.4 years STANDARD_DEVIATION 12.2 | 44.3 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 282 participants | 261 participants | 256 participants | 279 participants | 268 participants | 1346 participants |
| Sex: Female, Male Female | 158 Participants | 142 Participants | 143 Participants | 158 Participants | 152 Participants | 753 Participants |
| Sex: Female, Male Male | 124 Participants | 119 Participants | 113 Participants | 121 Participants | 116 Participants | 593 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 282 | 15 / 261 | 12 / 256 | 13 / 279 | 6 / 268 |
| serious Total, serious adverse events | 4 / 282 | 1 / 261 | 2 / 256 | 1 / 279 | 1 / 268 |
Outcome results
Primary
6 Month Self-reported Abstinence From Smoking
Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)
Time frame: 6 months
Population: intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patch | 6 Month Self-reported Abstinence From Smoking | 50 participants |
| Lozenge | 6 Month Self-reported Abstinence From Smoking | 52 participants |
| Bupropion | 6 Month Self-reported Abstinence From Smoking | 45 participants |
| Patch + Lozenge | 6 Month Self-reported Abstinence From Smoking | 75 participants |
| Buproion + Lozenge | 6 Month Self-reported Abstinence From Smoking | 80 participants |