Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

NCT06609369 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000037737R01DA061285
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Mean number cigarettes smoked per day

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

  Baseline, week 4, 8, 12, and 26

• Smoking status

  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).

  Baseline

• Quit status

  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)

  Week 4, 8, 12, and 26

• Days to smoking relapse

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

  Week 4, 8, 12, and 26

Secondary Outcomes (3)

• Change in PROMIS Sleep Disturbance

  Baseline, week 4, 8, 12, and 26

• Change in PROMIS Sleep-Related Impairment

  Baseline, week 4, 8, 12, and 26

• Change in Insomnia Severity Index

  Baseline, week 4, 8, 12, and 26

Study Arms (2)

Experimental health intervention

EXPERIMENTAL

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

Behavioral: Experimental health intervention; Drug: Varenicline

Control health intervention

ACTIVE COMPARATOR

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

Drug: Varenicline

Interventions

Experimental health intervention BEHAVIORAL

Behavioral health intervention

Experimental 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.

Control health intervention; Experimental health intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• currently enrolled in other treatments
• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation; Sleep Initiation and Maintenance Disorders

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Chiang-Shan Li

  Yale University

  PRINCIPAL INVESTIGATOR

• Lisa Fucito, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Chen, PhD

CONTACT

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

Lisa Fucito, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)