Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2029-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Tobacco Use Tobacco Cessation Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants who smoke randomly assigned and stratified by sex and severity of tobacco dependence

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Experimental health intervention

Intervention Type BEHAVIORAL

Behavioral health intervention

Varenicline

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

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

Interventions

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Experimental health intervention

Behavioral health intervention

Intervention Type BEHAVIORAL

Varenicline

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No