Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

NCT04061720 | Completed

• 1 other identifier: NURA-009-18F
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence; Veterans

Keywords

Tobacco dependence; Clinical Trial; Veterans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Initiating at least 1 cessation treatment call

  2 years

Study Arms (2)

Enhanced Chronic Care

EXPERIMENTAL

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.

Behavioral: Enhanced Chronic Care

Standard Care

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Interventions

Enhanced Chronic Care 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).

Enhanced Chronic Care

Standard Care 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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jessica Megan Cook, PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 20, 2019
• Study Start: November 12, 2019
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)