TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)

Gopalkumar Rakesh

Status

Completed

Conditions

Craving

HIV

Smoking Cessation

Treatments

Device: iTBS

Device: TMS

Study type

Interventional

Funder types

Other

Identifiers

NCT04936594

64473

Details and patient eligibility

About

The pilot study proposal aims to modulate craving and attentional bias towards smoking cues in 40 people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses of focused electricity. For the study, participants would perform two cognitive tasks and neuroimaging before and after the TMS and investigators would compare changes in these paradigms with TMS. The investigators will also get a point of contact urine drug screen before study initiation. The investigators will aim to recruit 20 subjects in each arm of our trial (total of 40) from the BlueGrass HIV Clinic.

Full description

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 cancer, 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. Suboptimal results with current smoking cessation strategies makes identifying new adjunct strategies an area of need. The pilot study proposal aims to modulate craving and attentional bias towards smoking cues in people living with HIV/AIDS (PLWHA) using transcranial magnetic stimulation (TMS), with functional MRI (fMRI) brain correlates. TMS is a form of noninvasive brain stimulation and modulates neural activity using tiny doses of focused electricity. The TMS paradigm we would be performing is called theta burst stimulation (TBS), which is potent, short, and efficient. It has shown to cause neuroplasticity even with a single session and was approved by the FDA for treatment of major depressive disorder in 2019.

Targeting the left dorsolateral prefrontal cortex (DLPFC) by using MNI coordinates (-44,40,29) via Brainsight Neuronavigation will modulate craving and attentional bias that is closely associated with craving. For this pilot study, 40 participants will perform the attentional bias task, craving scale and neuroimaging before and after the TBS/ sham TMS session, to compare changes in these paradigms between these interventions. Attentional bias would be measured with eye tracking, craving will be assessed with tobacco craving questionnaire (TCQ-SF). The investigators will aim to recruit 10 subjects from the BlueGrass HIV Clinic, who have an established pipeline for enrolling PLWHA patients in clinical trials. Although there is limited data on TMS in smoking, there have been no TMS studies done in PLWHA

Enrollment

9 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients enrolled in the Bluegrass Clinic
Confirmed chart diagnosis of a HIV and receiving HIV treatment at the participating HIV clinic
Age 18-60 years
Preferably right hand dominant
Currently self-report smoking 10 of more cigarettes per day or a score of > 5 on the Fagerstrom Test for Nicotine
Willing and able to abstain from all drug use
Exhaled breath on day of study Carbon Monoxide < 10 ppm
Stabilized on maintenance buprenorphine if having comorbid opioid use disorder
Able to read and speak English
Able to provide informed consent to participate.

Exclusion criteria

Pregnant, nursing, or becoming pregnant during the study
History of traumatic brain injury or seizures which are contraindications for transcranial magnetic stimulation (TMS)
Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, increased intracranial pressure, or history of significant head trauma with loss of consciousness for ≥ 5 minutes which are all contraindications for TMS
Presence of intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes), cardiac pacemakers, or vagus nerve stimulation device which are all contraindications for magnetic resonance imaging
Neurological disorder including, but not limited to: space occupying brain lesion; any history of seizures, history of cerebrovascular accident; fainting, cerebral aneurysm, major neurocognitive disorder, Huntington chorea; multiple sclerosis which are all contraindications for TMS.