Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

Tobacco Dependence Clinical Trial

Official title:

Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04061720
• Other study ID #: NURA-009-18F
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: use of cessation treatment and smoking abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care.

Description:

This project will generate knowledge about the effectiveness of Enhanced Chronic Care, an intervention designed to enhance treatment use and smoking abstinence in Veterans who are initially unwilling to quit. Enhanced Chronic Care provides ongoing motivational interventions and interpersonal support designed to promote readiness to quit smoking. Enhanced Chronic Care will be compared with Standard Care (brief advice to quit once per year) on criteria that are of great clinical and public health importance: smoking treatment reach (use of cessation treatment) and abstinence. It is expected that Enhanced Chronic Care will increase treatment use and smoking abstinence relative to Standard Care. The investigators will evaluate these interventions using a 2-arm randomized controlled trial. Veterans who smoke daily, but who are not willing to enter smoking cessation treatment, will be eligible to participate, with no obligation to quit smoking. Participants (N=500) will be randomized to one of the following treatments: 1) Enhanced Chronic Care (n=250) or 2) Standard Care (n=250). These intervention conditions will last 2 years to permit analysis of their cumulative impact on abstinence and treatment use

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 502
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Not willing to set a quit date in the next 30 days
• Report smoking an average of 4 or more cigarettes daily for at least six months
• Read, write, and speak English
• Be medically eligible to use nicotine replacement therapy
• If female, use an approved method of birth control if they use nicotine replacement therapy
• Agree to participate in the study
• Be at least 18 years old
• Be a Veteran

Exclusion Criteria:

• Unable to give informed, voluntary consent to participate
• Current use of any pharmacotherapy for smoking cessation not provided by the researchers during tobacco treatment
• Use of non-cigarette tobacco products as a primary form of tobacco use
• Incarceration

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder
• Veterans

Intervention

Behavioral:
• Enhanced Chronic Care
Enhanced Chronic Care involves four chronic care calls per year. Enhanced Chronic Care is designed to help participants explore their goals and concerns with regard to smoking, engage in a nondirective, supportive, motivational interventions, and provide information about evidence-based smoking treatment available to them and ways to initiate treatment (i.e., warm hand-off from a clinical provider).
• Standard Care
Standard Care involves one call per year. During the Standard Care call, participants will be encouraged to quit smoking, reminded of the cessation treatment available to them, and provided with a number to call should they become interested in treatment.

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-Day Point-Prevalence Abstinence	Participants who self-report no smoking for the past 7 days at the assessment endpoint (2-year follow-up) will be considered to meet criteria for 7-Day Point-Prevalence Abstinence. Participants who report any smoking in the past 7 days (at the 2 year follow-up) will be considered to be relapsed (smoking).	2 years
Secondary	Initiating at least 1 cessation treatment call	Cessation treatment use will be defined as making at least one treatment contact (initiating at least 1 cessation treatment call with reach coded as a binary outcome: use vs. no use).	2 years