Longitudinal Care: Smoking Reduction to Aid Cessation

Chronic Diseases Clinical Trial

Official title:

Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309296
• Other study ID #: TLC
• Secondary ID: P50DA013333-07
• Status: Completed
• Phase: N/A
• First received: March 30, 2006
• Last updated: February 11, 2011
• Start date: November 2005
• Est. completion date: December 2009

Study information

• Verified date: February 2011
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.

Description:

Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.

Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.

Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80

• Current and regular smoker 5 or more cigarettes per day

• Interested in making a quit attempt in the next 14 days

• Personal phone available

Exclusion Criteria:

• Pregnancy or plans to become pregnant in the next year

• Cannot speak English

• Not a union member or employee of specified worksite or immediate family member

• Member of household is currently enrolled in the study

• Not willing to comply with study protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

Behavioral:
• smoking cessation
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.

Locations

Country	Name	City	State
United States	Minneapolis VAMC	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health (NIH)	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be 6M of abstinence measured 18M after enrollment.	6M prolonged abstinence	18M	No
Secondary	7d point prevalent abstinence	Data collected at 21d, 3, 6, 12, 18M	18M	No
Secondary	30d point prevalent abstinence	Data collected at 3, 6, 12, 18M	18M	No
Secondary	Smoking reduction	Data collected at 3, 6, 12, 18M	18M	No
Secondary	Total duration of abstinence	Time Line Follow Back	18M	No