Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT06609369
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Insomnia
- Tobacco Cessation
- Tobacco Use
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Experimental health intervention — BEHAVIORALBehavioral health intervention
- Varenicline — DRUGDays 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.
Study Details
The study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.
Key Dates
- Start date
- Apr 21, 2025
- Status verified
- Jun 2026
- Primary completion
- Jun 30, 2029
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 114 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental health interventionExperimental health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
- Active Comparator: Control health interventionControl health intervention and varenicline starting 4 weeks before and continuing for 4 weeks after a target quit date for a total of 8 weeks
Primary Outcome Measure
Mean number cigarettes smoked per day [ Time Frame: Baseline, week 4, 8, 12, and 26 ]
Central Contacts
- Yu Chen, PhD347-819-2969
- Lisa Fucito, PhD203-200-1470
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | |
| Yale University | New Haven | Connecticut | 06520 |
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