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NCT06609369 | NOT YET RECRUITING | Tobacco Use

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Sponsor:

Yale University

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.

Condition or disease

Tobacco Use

Tobacco Cessation

Insomnia

Intervention/treatment

Experimental health intervention

Varenicline

Phase

PHASE2

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 114 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Actual Study Start Date : 2025-02-01
Estimated Primary Completion Date : 2029-06
Estimated Study Completion Date : 2029-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * English literate
  • * report heavy tobacco use (including nicotine e-cigarettes) for \>1 year
  • * 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
Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Location Details

NCT06609369

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520