Tobacco Dependence Clinical Trial
Official title:
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
Verified date | November 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 502 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | 2 years |
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