Smoking CessationVAntageNCT05868421
Veteran Social Support for Enhancing Use of Smoking Cessation Treatment
A study testing Support Person Coaching Call, SP written materials and Written Smoking Cessation Materials in people with Smoking Cessation and Veterans Health, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study is recruiting Veterans who currently smoke cigarettes and support persons who are nominated by the Veterans. The purpose of this study is to assist Veterans with smoking cessation by asking Veterans to choose a support person who will assist them with the quitting process, or who may assist them with the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Veterans Health
- What is being tested?
- Support Person Coaching Call, SP written materials and Written Smoking Cessation Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,376 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran Inclusion Criteria
- Smoked 1 cigarettes over the past 30 days, even a puff
- If using other tobacco or nicotine products, cigarettes are the main product used
- Able to identify one adult family member or friend (SP) with whom they have contact (of any form) at least 3 times per week who will enroll Veteran Support Person Inclusion Criteria
- Willing to support the Veteran smoker
- Have to have access to any type of phone (or tablet for video call) for delivery of the SP intervention
Who cannot join
- Veteran Exclusion Criteria
- Have used cessation medications or a stop smoking program within the past 3 months
- Have no valid phone contact information
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Alicia B Woodward-Abel, 612-467-1229, alicia.woodward-abel@va.gov
Sarah Becker, (612) 467-1515, Sarah.Becker4@va.gov
About this study
Official title: Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation
This study is recruiting Veterans who currently smoke cigarettes and support persons who are nominated by the Veterans. The purpose of this study is to assist Veterans with smoking cessation by asking Veterans to choose a support person who will assist them with the quitting process, or who may assist them with the quitting process once the Veteran is ready to quit smoking sometime in the future. Study staff will assess how much or how little social support during the Veteran's quitting process is helpful to the Veteran. This information will help us come up with new ways to help Veterans quit smoking that are better tailored to their needs.
Read the detailed description
Background: Enhancing access and use of evidence-based tobacco cessation treatments and eliminating tobacco-related health disparities are top national and VA health services priorities. The prevalence of tobacco use is greater among Veterans compared to non-Veterans. From 2010-2015, 29% of women and 21% of male Veterans reported current cigarette smoking. Evidence-based cessation treatments (EBCTs) such as, tobacco quitlines, behavioral counseling, and pharmacotherapy, are greatly underutilized by Veteran smokers. Gaps remain in reaching women Veterans and use of existing social support networks to enhance use of EBCTs and cessation among Veterans.
Specific Aims. Aim 1: To evaluate the impact of the social support intervention on Veteran smokers' use of EBCT. Aim 2: To examine the effectiveness of the social support intervention on the biochemically confirmed 7-day point prevalence cigarette smoking abstinence. Aim 3: To explore potential moderators (e.g., smoker gender, SP tobacco use status) of intervention effects on study outcomes. Aim 4: To conduct a process evaluation assessing implementation outcomes (reach, adoption, fidelity) of the social support intervention and multilevel factors that may influence implementation.
Methods: The investigators will conduct a pragmatic randomized controlled trial (RCT) within the national VHA health system to evaluate the effectiveness of a social support intervention compared with a control condition on utilization of EBCT among VHA-enrolled smokers. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record and proactively recruited. Interested smokers will be asked to identify a support person (SP) who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 594 dyads) or control condition (n= 594 dyads). All smokers will receive written resources and information on EBCTs. All SP participants will receive written materials. SP participants assigned to the intervention group will additionally receive a 1-call coaching session. Assessments for dyads in both study groups will be conducted at baseline, 3-, and 6-months post-randomization.
Innovation and Impact: This project is innovative for evaluating social support networks as a proactive outreach approach to enhance cessation treatment utilization among Veteran smokers. The role of social network influences and social support on successful smoking cessation is established. Based on Cohen's theory of social support, the team developed a social support intervention for diverse family members, friends, and other adults who wanted to help a smoker quit. The intervention consists of written materials and a 1-call, 15-25 minute coaching session. It is expected to be especially beneficial for Veteran smokers who might not otherwise access cessation treatment. Because the prior VHA trials enrolled about 94% men and the higher smoking rates among women, the investigators will oversample women to enroll an equal number of men and women smokers. This study contributes to VA HSR\&D's priority initiatives for enhancing treatment access and women's health and is significant because it will advance research on the role of partnering with Veterans' families and/or important others to enhance access to VA healthcare and population-specific treatments, especially women Veterans. The potential reach and public health impact of an effective social support intervention for the Veteran tobacco user population is considerable.
Implementation/Next Steps: Next steps depend on the actual results, but the investigators expect findings to be important to VA leaders, the VA Women's Health Research Consortium and the Veteran community. The investigators will maintain communication throughout the project with VA program partners to share findings in a timely manner. The investigators will collaborate with CCDOR's Veteran Engagement Panel on development of patient-centered dissemination approaches and recommendations for future intervention adaptations and/or implementation.
- Conditions
- Smoking Cessation, Veterans Health
- Being tested
- Support Person Coaching Call, SP written materials, Written Smoking Cessation Materials
- Keywords
- Smoking cessation, Social support, Veterans health, Tobacco cessation, Support persons
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support Person Coaching CallBehavioural
Also called SP Coaching Call Intervention
Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The session will be delivered by research staff by phone or video call. Support persons in the intervention group and the control/no intervention group will receive existing written material resources on support strategies to stop smoking, and resources on how to stop smoking by postal mail or email.
SP written materialsBehavioural
Also called Written support person strategies
Written materials covering tips on effective supportive strategies for smoking cessation
Written Smoking Cessation MaterialsBehavioural
Written materials on resource and referral information for VHA and non-VHA EBCT options
| Study group | Role | What they receive |
|---|---|---|
| Support Person Coaching Call and Written Materials | Experimental | Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The coaching session will be delivered by research staff by phone or video call. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options. Receives: Behavioral: Support Person Coaching Call; Behavioral: SP written materials; Behavioral: Written Smoking Cessation Materials |
| Written Materials Only | Active comparator | Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options. Receives: Behavioral: SP written materials; Behavioral: Written Smoking Cessation Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Any Evidence-Based Cessation Treatments (EBCTs)
The primary outcome will be use of any EBCT assessed at the 6 month follow-up: medication, behavioral intervention, or combination using both self-report and VHA administrative data. Data will be extracted from the VA Corporate Data Warehouse (CDW) to assess VA treatment use. VA outpatient prescription records will be used to assess receipt and amount of pharmacotherapy (bupropion, varenicline, nicotine replacement therapy (NRT)) and VA outpatient encounters associated with smoking cessation will be assed using stop codes (i.e., 707 and 708) and/or diagnoses treated for nicotine dependence (i.e., ICD10-F17.XX) to assess behavioral interventions. Use of QuitVET, SmokefreeVET, Department of Defense (DoD) and non-VHA treatment use will be assessed using self-report.
Measured: 6 months
Secondary outcomes (5)
Biochemically confirmed 7-day point prevalence cigarette smoking abstinence
For this trial, the focus with respect to abstinence is on combustible cigarette smoking. The investigators will assess self-reported 7-day point-prevalence abstinence 6-months and obtain biochemical verification at 6 months, defined as a negative carbon monoxide (CO) breath test (0-6 ppm) or negative salivary cotinine (< 30 ng/ml). Biochemical verification will be obtained using expired CO by mailing an iCO Smokerlyzer®, a small, portable, handheld breath CO monitor that connects to a mobile device or tablet, as the primary modality because carbon monoxide is not confounded by use of NRT, smokeless tobacco or e-cigarettes.
Measured: 6 months
Use of Any Evidence-Based Cessation Treatments (EBCTs)
use of any EBCT: medication, behavioral intervention, or combination using both self-report and VHA administrative data
Measured: 3 months
Self-reported 7-day point prevalence cigarette smoking abstinence
Any cigarette smoking in the past 7 days, even a puff
Measured: 6 months
Self-reported 7-day point prevalence cigarette smoking abstinence
Any cigarette smoking in the past 7 days, even a puff
Measured: 3 months
Prolonged smoking abstinence
Self-report of no smoking through 6-months follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pragmatic randomized controlled trial that will randomize Smoker-Support Person dyads with 1:1 allocation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven S. Fu, MD MSCE, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868421
- Sponsor's protocol ID
- IIR 20-117
- Acronym
- VAntage
- Status last verified
- Jan 2026
- First submitted
- 5 May 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets underlying all publications will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA). Analytic datasets will be housed on VINCI data servers. Outside investigators can follow VA procedures and receive training and approval for access within VA firewalls.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation
- ClinicalTrials.gov ID
- NCT05868421
- Acronym / sponsor ID
- VAntage / IIR 20-117
- Conditions
- Smoking Cessation, Veterans Health
- Keywords
- Smoking cessation, Social support, Veterans health, Tobacco cessation, Support persons
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,376 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is recruiting Veterans who currently smoke cigarettes and support persons who are nominated by the Veterans. The purpose of this study is to assist Veterans with smoking cessation by asking Veterans to choose a support person who will assist them with the quitting process, or who may assist them with the quitting process once the Veteran is ready to quit smoking sometime in the future. Study staff will assess how much or how little social support during the Veteran's quitting process is helpful to the Veteran. This information will help us come up with new ways to help Veterans quit smoking that are better tailored to their needs.
Detailed description
Background: Enhancing access and use of evidence-based tobacco cessation treatments and eliminating tobacco-related health disparities are top national and VA health services priorities. The prevalence of tobacco use is greater among Veterans compared to non-Veterans. From 2010-2015, 29% of women and 21% of male Veterans reported current cigarette smoking. Evidence-based cessation treatments (EBCTs) such as, tobacco quitlines, behavioral counseling, and pharmacotherapy, are greatly underutilized by Veteran smokers. Gaps remain in reaching women Veterans and use of existing social support networks to enhance use of EBCTs and cessation among Veterans.
Specific Aims. Aim 1: To evaluate the impact of the social support intervention on Veteran smokers' use of EBCT. Aim 2: To examine the effectiveness of the social support intervention on the biochemically confirmed 7-day point prevalence cigarette smoking abstinence. Aim 3: To explore potential moderators (e.g., smoker gender, SP tobacco use status) of intervention effects on study outcomes. Aim 4: To conduct a process evaluation assessing implementation outcomes (reach, adoption, fidelity) of the social support intervention and multilevel factors that may influence implementation.
Methods: The investigators will conduct a pragmatic randomized controlled trial (RCT) within the national VHA health system to evaluate the effectiveness of a social support intervention compared with a control condition on utilization of EBCT among VHA-enrolled smokers. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record and proactively recruited. Interested smokers will be asked to identify a support person (SP) who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 594 dyads) or control condition (n= 594 dyads). All smokers will receive written resources and information on EBCTs. All SP participants will receive written materials. SP participants assigned to the intervention group will additionally receive a 1-call coaching session. Assessments for dyads in both study groups will be conducted at baseline, 3-, and 6-months post-randomization.
Innovation and Impact: This project is innovative for evaluating social support networks as a proactive outreach approach to enhance cessation treatment utilization among Veteran smokers. The role of social network influences and social support on successful smoking cessation is established. Based on Cohen's theory of social support, the team developed a social support intervention for diverse family members, friends, and other adults who wanted to help a smoker quit. The intervention consists of written materials and a 1-call, 15-25 minute coaching session. It is expected to be especially beneficial for Veteran smokers who might not otherwise access cessation treatment. Because the prior VHA trials enrolled about 94% men and the higher smoking rates among women, the investigators will oversample women to enroll an equal number of men and women smokers. This study contributes to VA HSR\&D's priority initiatives for enhancing treatment access and women's health and is significant because it will advance research on the role of partnering with Veterans' families and/or important others to enhance access to VA healthcare and population-specific treatments, especially women Veterans. The potential reach and public health impact of an effective social support intervention for the Veteran tobacco user population is considerable.
Implementation/Next Steps: Next steps depend on the actual results, but the investigators expect findings to be important to VA leaders, the VA Women's Health Research Consortium and the Veteran community. The investigators will maintain communication throughout the project with VA program partners to share findings in a timely manner. The investigators will collaborate with CCDOR's Veteran Engagement Panel on development of patient-centered dissemination approaches and recommendations for future intervention adaptations and/or implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pragmatic randomized controlled trial that will randomize Smoker-Support Person dyads with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Support Person Coaching Call and Written Materials | Experimental | Behavioral: Support Person Coaching Call, Behavioral: SP written materials, Behavioral: Written Smoking Cessation MaterialsSupport persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The coaching session will be delivered by research staff by phone or video call. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options. |
| Written Materials Only | Active comparator | Behavioral: SP written materials, Behavioral: Written Smoking Cessation MaterialsSupport persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran Inclusion Criteria
- Smoked 1 cigarettes over the past 30 days, even a puff
- If using other tobacco or nicotine products, cigarettes are the main product used
- Able to identify one adult family member or friend (SP) with whom they have contact (of any form) at least 3 times per week who will enroll Veteran Support Person Inclusion Criteria
- Willing to support the Veteran smoker
Key exclusion criteria (3 listed)
- Veteran Exclusion Criteria
- Have used cessation medications or a stop smoking program within the past 3 months
- Have no valid phone contact information
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 |
|---|---|---|
| Support Person Coaching CallAlso: SP Coaching Call InterventionSupport person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The session will be delivered by research staff by phone or video call. Support persons in the intervention group and the control/no intervention group will receive existing written material resources on support strategies to stop smoking, and resources on how to stop smoking by postal mail or email. | Behavioural | Support Person Coaching Call and Written Materials |
| SP written materialsAlso: Written support person strategiesWritten materials covering tips on effective supportive strategies for smoking cessation | Behavioural | Support Person Coaching Call and Written Materials, Written Materials Only |
| Written Smoking Cessation MaterialsWritten materials on resource and referral information for VHA and non-VHA EBCT options | Behavioural | Support Person Coaching Call and Written Materials, Written Materials Only |
Primary outcome
Use of Any Evidence-Based Cessation Treatments (EBCTs)
Time frame: 6 months
The primary outcome will be use of any EBCT assessed at the 6 month follow-up: medication, behavioral intervention, or combination using both self-report and VHA administrative data. Data will be extracted from the VA Corporate Data Warehouse (CDW) to assess VA treatment use. VA outpatient prescription records will be used to assess receipt and amount of pharmacotherapy (bupropion, varenicline, nicotine replacement therapy (NRT)) and VA outpatient encounters associated with smoking cessation will be assed using stop codes (i.e., 707 and 708) and/or diagnoses treated for nicotine dependence (i.e., ICD10-F17.XX) to assess behavioral interventions. Use of QuitVET, SmokefreeVET, Department of Defense (DoD) and non-VHA treatment use will be assessed using self-report.
5 secondary outcomes
Biochemically confirmed 7-day point prevalence cigarette smoking abstinence
Time frame: 6 months
Use of Any Evidence-Based Cessation Treatments (EBCTs)
Time frame: 3 months
Self-reported 7-day point prevalence cigarette smoking abstinence
Time frame: 6 months
Self-reported 7-day point prevalence cigarette smoking abstinence
Time frame: 3 months
Prolonged smoking abstinence
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. Final datasets underlying all publications will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA). Analytic datasets will be housed on VINCI data servers. Outside investigators can follow VA procedures and receive training and approval for access within VA firewalls.
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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.
Steven S. Fu, MD MSCE principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support Person Coaching Call, SP written materials and Written Smoking Cessation Materials in people with Smoking Cessation and Veterans Health, 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicia B Woodward-Abel ((612) 467-1229, alicia.woodward-abel@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Any Evidence-Based Cessation Treatments (EBCTs) (time frame: 6 months). 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 16 Jan 2026.