Smoking Cessation Intervention: Effectiveness in Primary Care

Tobacco Dependence Clinical Trial

Official title:

Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296647
• Other study ID #: H-2004-0462
• Secondary ID: P50DA019706
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2006
• Last updated: October 9, 2015
• Start date: September 2004
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00106873

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1346
• Est. completion date: December 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• nicotine patch
Decreasing dosages from 21 to 7 mg over 12 week period
• nicotine patch
Decreasing dosage from 21 to 7 mg over 12 weeks
• nicotine lozenge
4 mg nicotine lozenge: dosage according to package directions for 16 weeks
• bupropion
dosage according to prescription directions: 12 weeks
• patch + lozenge
dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)
• bupropion + lozenge
dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)

Locations

Country	Name	City	State
United States	UW-CTRI Milwaukee Research site	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	6 months	No

External Links

•   web site of the study lead investigators