Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

Study Overview
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Brief Summary
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To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.

Detailed Description
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The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general population. These extraordinary smoking rates are associated with greater AIDS-related morbidity, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and outcome of HIV disease and has been identified as the leading contributor to premature mortality in PLWHA. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.

Official Title
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Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

Conditions
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Hiv, Tobacco Smoking

Intervention / Treatment
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* Device: TBS
* Device: Sham TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential participants will be Patients enrolled in the Bluegrass Clinic 18-60 years of age Male or female gender Able to read, understand and communicate in English Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic Willing and able to abstain from drug use other than Suboxone Exhaled breath on day of study carbon monoxide (CO) < 5 ppm Stabilized on maintenance buprenorphine if having comorbid opioid use disorder. Exclusion Criteria: Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel. Previous adverse effect with TMS. Sub-threshold consistency while performing behavioral tasks. Failure to show baseline attentional bias to smoking versus neutral cues.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active group and sham group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TBS (Theta burst stimulation)<br>Four sessions of TBS in one day | Device: TBS<br>* Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.<br>|
| Placebo Comparator: Sham TMS<br>Four sessions of sham TMS | Device: Sham TMS<br>* Four sessions of sham TMS delivered using MagVenture B65 A/P coil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gaze Fixation on Smoking Cues | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome | On Day 1 of the study | 
| Gaze Fixation on Smoking Cues | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome | On Day 1 of the study after intervention | 
| Craving for cigarettes | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher. | On day one of the study. | 
| Craving for cigarettes | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher. | Immediately after intervention (sessions of TBS or sham TMS) on day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional connectivity changes | Changes in functional connectivity measured using z score on functional MRI brain scan. | on Day 1 of study | 
| Functional connectivity changes | Changes in functional connectivity measured using z score on functional MRI brain scan. | Immediately after intervention (sessions of TBS or sham TMS) on day 1 |