Smoking Cessation Intervention: Effectiveness in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00296647
First received: February 24, 2006
Last updated: October 21, 2011
Last verified: October 2011
  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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296647

Locations
United States, Wisconsin
UW-CTRI Milwaukee Research site
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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
Chemically-Induced Disorders
Mental Disorders
Nicotine
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014