Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

NCT ID: NCT04061720

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2025-09-26

Brief 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.

Detailed 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

Conditions

Tobacco Dependence; Veterans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Enhanced Chronic Care

Enhanced Chronic Care provides ongoing, phone-based motivational interventions and interpersonal support to promote readiness to quit, with facilitated access to evidence-based smoking treatment.

Group Type: EXPERIMENTAL

Enhanced Chronic Care

Intervention Type: BEHAVIORAL

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 provides phone-based brief advice to quit once per year.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Megan Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital, Madison, WI

Locations

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NURA-009-18F

Identifier Type: -

Identifier Source: org_study_id