Smoking Cessation Intervention: Effectiveness in Primary Care
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Purpose
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Dependence |
Drug: nicotine patch Drug: nicotine lozenge Drug: bupropion Drug: patch + lozenge Drug: bupropion + lozenge |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care |
- 6 Month Self-reported Abstinence From Smoking [ Time Frame: 6 months ] [ Designated as safety issue: No ]Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)
| Enrollment: | 1346 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: patch |
Drug: nicotine patch
Decreasing dosages from 21 to 7 mg over 12 week period
Drug: nicotine patch
Decreasing dosage from 21 to 7 mg over 12 weeks
|
| Active Comparator: nicotine lozenge |
Drug: nicotine lozenge
4 mg nicotine lozenge: dosage according to package directions for 16 weeks
|
| Active Comparator: bupropion |
Drug: bupropion
dosage according to prescription directions: 12 weeks
|
| Active Comparator: patch + lozenge |
Drug: patch + lozenge
dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
|
| Active Comparator: buproion + lozenge |
Drug: bupropion + lozenge
dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Wisconsin | |
| UW-CTRI Milwaukee Research site | |
| Milwaukee, Wisconsin, United States, 53233 | |
| Principal Investigator: | Thomas C Jackson, MD | Aurora Health Care |
More Information
Additional Information:
No publications provided by University of Wisconsin, Madison
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00296647 History of Changes |
| Obsolete Identifiers: | NCT00106873 |
| Other Study ID Numbers: | P50DA19706-2, P50DA019706 |
| Study First Received: | February 24, 2006 |
| Results First Received: | October 21, 2011 |
| Last Updated: | October 21, 2011 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Bupropion Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013