Nicotine Addiction
Conditions
Keywords
low intensity focused ultrasound
Brief summary
This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking. Smoking is associated with cancers of the lung. Available smoking cessation methods help many to quit. However, for the many who continue to smoke despite the strong desire to quit and after exhausting existing therapeutic approaches, new treatment methods are needed. Without more effective treatment, many will continue to smoke, and our progress on cancer prevention through smoking cessation may decelerate as these associated cancer risks will remain. Brain imaging research has identified specific areas of the brain linked to severe nicotine addiction, but up to now there are no effective ways to directly target most of these deeper brain regions. LIFU is a new and safe method to modulate brain functions that can either inhibit overactive activity or restore normal activity levels. The purpose of this study is to provide a novel ultrasound-based neuromodulation strategy for smoking cessation in people who have difficulty to quit smoking despite numerous serious attempts in their lives. LIFU works by sending acoustic pressure modulating neural activity in the human brain.
Interventions
DEVICELow intensity focused ultrasound with active stimulations
Participants will receive two LIFU sessions a week for 4 weeks.
DEVICElow intensity focused ultrasound with sham stimulations
Participants will receive two LIFU sessions a week for 4 weeks.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must be a smoker for 5 or more years and within 20 to 60 years of age 2. Must not meet
Exclusion criteria
for MRI scanning (e.g., non-fixed magnetizable objects) 3. Must not have ongoing unstable medical, neurological or psychiatric illness as determined by a combination of history, medical record, and/or examination. 4. Must be a current smoker with average of 5 cigarettes or more a day for the last month or longer. 5. Report 3 or more trials of smoking cessation attempts using nicotine replacement, e-cig, TMS, varenicline or other smoking cessation drugs, psychotherapy or other means.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette per day (CPD) | Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline). | Cigarette per day (CPD) is measured to index smoking reduction and cessation. |
| Brain connectivity as indicated by resting state functional connectivity (rsFC) value as assessed by functional magnetic resonance imaging (fMRI) | session 1 (about 1-2 days after baseline) and session 8 (about 4 weeks after baseline). | The strength of rsFC from fMRI is used to represent the brain activities that are corresponding to the transcranial magnetic stimulation (TMS) effect on smoking reduction/cessation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End-expired carbon monoxide (CO) | Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline). | End-expired CO measure is an instant measure of smoking status, with higher CO level indicating more severe recent smoking behavior. |
| Urinary cotinine level | Baseline, session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline). | Urinary cotinine is an index of smoking status, with higher cotinine concentrations indicating more severe smoking behavior. |
| Quit rate (%) | Session 1 (about 1-2 days after baseline), session 8 (about 4 weeks after baseline), and 1-week follow up (about 5 weeks after baseline). | Quit rate is an index of smoking cessation effects of the treatment. |
Countries
United States
Contacts
CONTACTXiaoming Du, PhD
CONTACTAlina Siatka
PRINCIPAL_INVESTIGATORXiaoming Du, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed