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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental health intervention — BEHAVIORAL
    Behavioral health intervention
  • Varenicline — DRUG
    Days 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 intervention
    Experimental 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 intervention
    Control 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

Locations (2)

FacilityCityStateZIPSite coordinators
Connecticut Mental Health CenterNew HavenConnecticut06519
Yu Chen, PhD
475-261-6153
Yale UniversityNew HavenConnecticut06520
Yu Chen, PhD
475-261-6153

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