Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Yale University

Status and phase: Enrolling; Phase 2

Conditions: Insomnia; Tobacco Cessation; Tobacco Use

Treatments: Drug: Varenicline; Behavioral: Experimental health intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06609369

2000037737

R01DA061285 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Experimental health intervention

Experimental group

Description:

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

Treatment:

Behavioral: Experimental health intervention

Drug: Varenicline

Control health intervention

Active Comparator group

Description:

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

Treatment:

Drug: Varenicline