Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental health intervention, Varenicline.
- Who it may be relevant to
- Registry conditions: Tobacco Use, Tobacco Cessation, Insomnia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Experimental health intervention
Behavioral health intervention - Drug Varenicline
Days 1-3: 0.5mg once daily, Days 4-7: 0.5mg twice daily; Days 8-56: 1.0mg twice daily.
Primary outcome measures
- Mean number cigarettes smoked per day [Time frame: Baseline, week 4, 8, 12, and 26]
- Smoking status [Time frame: Baseline]
- Quit status [Time frame: Week 4, 8, 12, and 26]
- Days to smoking relapse [Time frame: Week 4, 8, 12, and 26]
Secondary outcome measures (3)
- Change in PROMIS Sleep Disturbance [Time frame: Baseline, week 4, 8, 12, and 26]
- Change in PROMIS Sleep-Related Impairment [Time frame: Baseline, week 4, 8, 12, and 26]
- Change in Insomnia Severity Index [Time frame: Baseline, week 4, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Connecticut Mental Health Center — New Haven
- Yale University — New Haven
Identifiers
NCT: NCT06609369 · 2000037737 · R01DA061285