Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

VA Office of Research and Development

Status: Active, not recruiting

Conditions: Tobacco Dependence; Veterans

Treatments: Behavioral: Enhanced Chronic Care; Behavioral: Standard Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04061720

NURA-009-18F

Details and patient eligibility

About

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.

Full 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

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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502 participants in 2 patient groups

Enhanced Chronic Care

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Chronic Care

Standard Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Care