Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

Not Applicable

Active, not recruiting

• Conditions: Tobacco Dependence; Veterans
• Interventions: Behavioral: Enhanced Chronic Care; Behavioral: Standard Care

• Registration Number: NCT04061720
• Lead Sponsor: VA Office of Research and Development

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

Study Timeline

• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-20
• Study Start: 2019-11-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 502

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Chronic Care	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.
Standard Care	Standard Care	Standard Care provides phone-based brief advice to quit once per year.

Primary Outcome Measures

Name	Time	Method
7-Day Point-Prevalence Abstinence	2 years	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).

Secondary Outcome Measures

Name	Time	Method
Initiating at least 1 cessation treatment call	2 years	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).

Trial Locations

Locations (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States