Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Primary Purpose
Tobacco Dependence, Veterans
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Chronic Care
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Dependence focused on measuring Tobacco dependence, Clinical Trial, Veterans
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
Sites / Locations
- William S. Middleton Memorial Veterans Hospital, Madison, WIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced Chronic Care
Standard Care
Arm 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.
Standard Care provides phone-based brief advice to quit once per year.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Initiating at least 1 cessation treatment call
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).
Full Information
NCT ID
NCT04061720
First Posted
August 16, 2019
Last Updated
December 23, 2022
Sponsor
VA Office of Research and Development
Collaborators
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04061720
Brief Title
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Official Title
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Veterans
Keywords
Tobacco dependence, Clinical Trial, Veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enhanced Chronic Care
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard Care provides phone-based brief advice to quit once per year.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Chronic Care
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
7-Day Point-Prevalence Abstinence
Description
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).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Initiating at least 1 cessation treatment call
Description
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).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica M Cook, PhD
Phone
(608) 256-1901
Email
Jessica.Cook2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Megan Cook, PhD
Organizational Affiliation
William S. Middleton Memorial Veterans Hospital, Madison, WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica M Cook, PhD
Phone
(608) 256-1901
Email
Jessica.Cook2@va.gov
First Name & Middle Initial & Last Name & Degree
Jessica Megan Cook, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
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