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NCT07039175: MINDSET

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

Recruiting now Phase 3 Last updated 31 December 2025
What this trial tests

Phase 3 trial testing MINDSET in Tobacco Smoking in 270 participants. Currently enrolling.

Timeline
1 October 2025
Primary endpoint
31 December 2028
30 June 2029

Quick facts

Lead sponsorVA Office of Research and Development
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment270
Start date1 October 2025
Primary completion31 December 2028
Estimated completion30 June 2029
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Tobacco Smoking or Alcohol-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of MINDSET

Trials testing the same drug.

Other recruiting trials for Tobacco Smoking

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07039175.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing