Recruiting
Phase 2

Observational Study

Sponsor:

Yale University

Code:

NCT06609369

Conditions

Tobacco Use

Tobacco Cessation

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Experimental health intervention

Varenicline

Study Details

Brief summary:

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.

Conditions

Tobacco Use

Tobacco Cessation

Insomnia

Study ID

NCT06609369

Start date

Apr 21, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English literate
  • report heavy tobacco use (including nicotine e-cigarettes) for >6 months
  • meet biochemical cut off for recent cigarette smoking or e-cigarette use
  • optimal body mass index

Exclusion Criteria:

  • currently enrolled in other treatments
  • neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep
  • medical contraindications for fMRI, varenicline, and/or behavioral treatment
  • factors that cause deficient sleep and for which behavioral treatment has less benefit
  • women who are pregnant or nursing

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Experimental health intervention

Behavioral health intervention

Varenicline

Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.

Primary outcome measure

  • Mean number cigarettes smoked per day [ Time Frame: Baseline, week 4, 8, 12, and 26 ]
  • Smoking status [ Time Frame: Baseline ]
  • Quit status [ Time Frame: Week 4, 8, 12, and 26 ]
  • Days to smoking relapse [ Time Frame: Week 4, 8, 12, and 26 ]

Central Contacts and Locations

Central contacts

Yu Chen, PhD

347-819-2969yu.chen.yc838@yale.edu

Lisa Fucito, PhD

203-200-1470lisa.fucito@yale.edu

Locations

Connecticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Yu Chen, PhD

475-261-6153sleepstudy@yale.edu

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Yu Chen, PhD

475-261-6153sleepstudy@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-05.