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NCT Number: NCT06609369

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

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.

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Key information

Conditions

Tobacco Use Behavior Dyssomnias Health Behavior Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Tobacco Cessation Tobacco Use Cessation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Connecticut Mental Health Center, New Haven, Connecticut, United States

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About this study

The primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. The secondary objective of this study is to examine sex differences.

Investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient Tobacco Treatment Service (TTS) at Yale-New Haven Hospital.

All participants will be assigned to one of two behavioral interventions. Both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring.

Participants will have a total of five expected research visits with a scheduled target quit date for Week 4. Participants will undergo MRI at baseline and at Week 4, and attend follow-ups at week 8, 12, and 26.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean number cigarettes smoked per day

    Time frame: Baseline, week 4, 8, 12, and 26

    Mean number cigarettes smoked per day assessed by Time Line Follow Back method

  2. Smoking status

    Time frame: Baseline

    Assess expired breath carbon monoxide (CO) at baseline. CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels).

  3. Quit status

    Time frame: Week 4, 8, 12, and 26

    To inquire whether participants have refrained from tobacco use at each visit following their quit date. The quit status will also be verified by assessing expired breath carbon monoxide (CO). CO is a standard biomarker of combustible tobacco use, is sensitive to detecting cigarette substitution, and has a typical half-life of 4 hours, and is a standard biomarker for confirming recent smoking abstinence (CO <5ppm has optimal sensitivity and specificity for biochemically verifying smoking status, including at lower smoking levels)

  4. Days to smoking relapse

    Time frame: Week 4, 8, 12, and 26

    Days of resuming smoking since Week 4 schedule quit date as assessed by the Time Line Follow-back

Secondary outcomes

  1. Change in PROMIS Sleep Disturbance

    Time frame: Baseline, week 4, 8, 12, and 26

    The PROMIS Sleep Disturbance is an 8 item self-report of perceptions of sleep quality, sleep depth, and restoration associated with sleep. Each item on the measure is rated on a 5-point scale. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. High scores mean greater severity of sleep disturbance.

  2. Change in PROMIS Sleep-Related Impairment

    Time frame: Baseline, week 4, 8, 12, and 26

    The PROMIS Sleep-Related Impairment is an 8 item self-report of perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness. Each item on the measure is rated on a 4-point scale. The score range is 4 to 32. High scores mean greater severity of sleep related impairment.

  3. Change in Insomnia Severity Index

    Time frame: Baseline, week 4, 8, 12, and 26

    The Insomnia Severity Index is a 7-item brief screening tool for insomnia. Each item on the measure is rated on a 5-point scale (0-4), with a total score range 0-28. High scores mean greater severity of insomnia.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Fucito, PhD

CONTACT

[email protected]

203-200-1470

Yu Chen, PhD

CONTACT

[email protected]

347-819-2969

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 24, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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