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MoVIe: Varenicline + PSF-M for Tobacco Cessation in HIV
NCT05786547Phase 3
Key facts
- Status
- Recruiting
- Start
- Jan 2024
- Primary completion
- Jul 2026
- Countries
- 2
- Sponsor
- University of Colorado Denver
- Modality
- Small Molecules
- Drugs
- varenicline
- Conditions
- Tobacco Use Disorder (TUD)
01
Overview
Phase 3, randomised, open-label trial of varenicline in Tobacco Use Disorder (TUD) (2 arms), sponsored by University of Colorado Denver. Primary endpoint: 7-Day Point Prevalent Abstinence Rate at 24 weeks. Started Jan 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Varenicline + PSF-M
Varenicline (0.5mg QD days 1-3, 0.5mg BID days 4-7, 1.0mg BID days 8-84) + Positively Smoke Free Mobile App.
Standard Care
Brief tobacco cessation advice and referral to national quitline.
03
Who it enrols
Adults with HIV (VL < 1000, CD4 > 200) who smoke (CO >= 7 ppm) and are ready to quit. Excludes pregnant/breastfeeding women, recent MI/unstable angina, liver/kidney failure, history of suicide attempt/psychosis, or unstable depression.
04
Endpoints
Primary
7-Day Point Prevalent Abstinence Rate
Secondary
7-Day Self-Reported Point Prevalent Abstinence Rate
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