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Clinical Trials/NCT04061720
NCT04061720
Completed
N/A

Identifying Effective Treatment for Veterans Unwilling to Quit Smoking

VA Office of Research and Development1 site in 1 country502 target enrollmentNovember 12, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tobacco Dependence
Sponsor
VA Office of Research and Development
Enrollment
502
Locations
1
Primary Endpoint
7-Day Point-Prevalence Abstinence
Status
Completed
Last Updated
7 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 12, 2019
End Date
September 26, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

7-Day Point-Prevalence Abstinence

Time Frame: 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 Outcomes

  • Initiating at least 1 cessation treatment call(2 years)

Study Sites (1)

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