Tobacco DependenceNCT04061720
Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
A study testing Enhanced Chronic Care in people with Tobacco Dependence and Veterans, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence, Veterans
- What is being tested?
- Enhanced Chronic Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 26 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
About this study
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.
Read the 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
- Conditions
- Tobacco Dependence, Veterans
- Being tested
- Enhanced Chronic Care, Standard Care
- Keywords
- Tobacco dependence, Clinical Trial, Veterans
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Chronic CareBehavioural
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).
Standard CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Enhanced Chronic Care |
| Standard Care | Active comparator | Standard Care provides phone-based brief advice to quit once per year. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Participants who self-report no smoking for the past 7 days at 2-year follow-up were mailed a self-administered saliva sample collection kit. A saliva cotinine level of 10 ng/mL was used as the cutoff to determine smoking abstinence.
Measured: 2 years
Secondary outcomes (1)
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start12 Nov 2019
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Jessica Megan Cook, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061720
- Sponsor's protocol ID
- NURA-009-18F
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2019
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Effective Treatment for Veterans Unwilling to Quit Smoking
- ClinicalTrials.gov ID
- NCT04061720
- Acronym / sponsor ID
- NURA-009-18F
- Conditions
- Tobacco Dependence, Veterans
- Keywords
- Tobacco dependence, Clinical Trial, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Wisconsin, Madison
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Chronic Care | Experimental | Behavioral: Enhanced Chronic CareEnhanced 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 | Active comparator | Behavioral: Standard CareStandard Care provides phone-based brief advice to quit once per year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Chronic CareEnhanced 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). | Behavioural | Enhanced Chronic Care |
| Standard CareStandard 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. | Behavioural | Standard Care |
Primary outcome
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). Participants who self-report no smoking for the past 7 days at 2-year follow-up were mailed a self-administered saliva sample collection kit. A saliva cotinine level of 10 ng/mL was used as the cutoff to determine smoking abstinence.
1 secondary outcome
Initiating at Least 1 Cessation Treatment Call
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Megan Cook, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Chronic Care in people with Tobacco Dependence and Veterans, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point-Prevalence Abstinence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.