Clinical trial NCT06609369: Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Official title: Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Tobacco Use
Tobacco Cessation
Insomnia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-09-24
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who smoke randomly assigned and stratified by sex and severity of tobacco dependence
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean number cigarettes smoked per day
timeFrame: Baseline, week 4, 8, 12, and 26
measure: Smoking status
timeFrame: Baseline
measure: Quit status
timeFrame: Week 4, 8, 12, and 26
measure: Days to smoking relapse
timeFrame: Week 4, 8, 12, and 26
Secondary outcomes:
measure: Change in PROMIS Sleep Disturbance
timeFrame: Baseline, week 4, 8, 12, and 26
measure: Change in PROMIS Sleep-Related Impairment
timeFrame: Baseline, week 4, 8, 12, and 26
measure: Change in Insomnia Severity Index
timeFrame: Baseline, week 4, 8, 12, and 26
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Chiang-Shan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Lisa Fucito, PhD
role: PRINCIPAL_INVESTIGATOR
References: