NCT07039175 Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease
| NCT ID | NCT07039175 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | Tobacco Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 270 participants in total. It began in 2025-10-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Julie Christina Gass, PhD
PRINCIPAL INVESTIGATOR
VA Western New York Healthcare System, Buffalo, NY
Frequently Asked Questions
Who can join the NCT07039175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tobacco Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07039175 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 270 participants.
Is NCT07039175 currently recruiting?
Yes, NCT07039175 is actively recruiting participants. Contact the research team at Julie.Gass@va.gov for enrollment information.
Where is the NCT07039175 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT07039175 clinical trial?
NCT07039175 is sponsored by VA Office of Research and Development. The principal investigator is Julie Christina Gass, PhD at VA Western New York Healthcare System, Buffalo, NY. The trial plans to enroll 270 participants.