Clinical trial NCT04061720: Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Official title: Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Dependence
Veterans
Keywords: Tobacco dependence
Clinical Trial
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Wisconsin, Madison
First posted: 2019-08-20
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 7-Day Point-Prevalence Abstinence
timeFrame: 2 years
Secondary outcomes:
measure: Initiating at least 1 cessation treatment call
timeFrame: 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Jessica Megan Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References: