Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease

A Low-Cost, High-Access Intervention to Increase Intention to Change Alcohol/Tobacco Use Among Reticent Veterans Who Are Non-Responders to Brief Advice at High Risk Due to Chronic Conditions

Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease (NCT07039175) is a Phase 3 interventional studying Tobacco Smoking and Alcohol-Related Disorders, sponsored by VA Office of Research and Development. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking/smoking relate to the Veteran's condition (heart conditions and/or diabetes), followed by a brief motivational call. The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the relationships between these and other variables over time.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Tobacco Smoking, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 270 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Tobacco Smoking subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascular risk factor (hypertension {HTN}, hyperlipidemia {HLD}) AND signs of reticence to change their smoking and/or alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not). - Confirmation of smoking and/or drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not). - Veteran - Age 18 years - utilize VA for medical care more than 1 time per year - are due to complete their smoking/alcohol use screen in approximately 3 months (to ensure they will likely receive UC during intervention period) - a scheduled PC appointment within the intervention period. Who Should NOT Join This Trial: - dementia or severe cognitive impairment per Problem List - significant visual impairment per Problem List - Other Exclusion criteria assessed by study staff during screening/self-report are: - inability to communicate or read in English; - Hearing impairment; and - cognitive impairment or screening for cognitive impairment (\>=weighted score of 10 on Blessed screener). Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascular risk factor (hypertension {HTN}, hyperlipidemia {HLD}) AND signs of reticence to change their smoking and/or alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not). * Confirmation of smoking and/or drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not). * Veteran * Age 18 years * utilize VA for medical care more than 1 time per year * are due to complete their smoking/alcohol use screen in approximately 3 months (to ensure they will likely receive UC during intervention period) * a scheduled PC appointment within the intervention period. Exclusion Criteria: * dementia or severe cognitive impairment per Problem List * significant visual impairment per Problem List * Other Exclusion criteria assessed by study staff during screening/self-report are: * inability to communicate or read in English; * Hearing impairment; and * cognitive impairment or screening for cognitive impairment (\>=weighted score of 10 on Blessed screener).

Treatments Being Tested

BEHAVIORAL

MINDSET

A behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.

OTHER

Usual Care

All Veterans involved in this study will have a standard primary care (PC) appointment, which may include conversations/interventions related to drinking and smoking. This appointment is not controlled by the study team and we cannot comment on the extent to which smoking/drinking will or will not be discussed in the primary care appointment but we imagine this can range from no discussion/intervention at all to extensive conversations with the provision of medications, brief advice, etc.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07039175), the sponsor (VA Office of Research and Development), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07039175 clinical trial studying?

Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07039175?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07039175?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07039175. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07039175. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.