Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Helping Veterans with chronic disease reduce smoking and risky drinking

Official title: 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

Run by VA Office of Research and Development · NCT07039175 · Data updated 2026-11-12

This program will test whether a mailed, tailored education packet plus a brief motivational phone call helps Veterans with diabetes, heart disease, or related risk factors who smoke or drink too much become more motivated to change.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment270 (estimated)
SponsorVA Office of Research and Development
Federal
Locations1 site (Buffalo, New York)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedDecember 31, 2028
Study endsJune 30, 2029
Registry record updatedDecember 31, 2025
Trial IDNCT07039175 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Veterans aged 18 or older who receive VA primary care at the Buffalo VA, have diabetes, cardiovascular disease, or a cardiovascular risk factor, are current smokers and/or screen positive for hazardous drinking on two consecutive prior screens, use VA care regularly, and have a scheduled primary care appointment during the intervention period.

Probably not a fit

Patients with severe cognitive impairment, those not currently smoking or drinking hazardously, Veterans who already engage with higher-intensity cessation or alcohol treatment, or those who do not receive care at the Buffalo VA are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, phase 3 trial comparing a proactive, low-resource intervention called MINDSET to usual primary care. MINDSET delivers a mailed packet with tailored education linking smoking and drinking to the participant's chronic condition, followed by a brief motivational telephone call. The study measures changes in intention to change, substance use behaviors, and related variables over time. Outcomes will be compared between the MINDSET group and usual care to determine effectiveness for reticent Veterans.

Why it matters

Potential benefit: If successful, MINDSET could increase motivation to reduce smoking and hazardous drinking and potentially lower substance use and related chronic disease complications among Veterans.

How similar studies have gone: A prior pilot of MINDSET showed promise, and related brief motivational interventions using mailed materials and phone calls have produced modest positive effects, though large randomized trials in this specific population remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • VA Western New York Healthcare System, Buffalo, NY
    Buffalo, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Julie Christina Gass, PhD — VA Western New York Healthcare System, Buffalo, NY
  • Study coordinator: Julie C Gass, PhD
  • Email: Julie.Gass@va.gov
  • Phone: (716) 834-9200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.