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

NCT ID: NCT04936594

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2021-11-24

Brief Summary

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.

Detailed 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

Conditions

Smoking Cessation; HIV; Craving

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

People Living with HIV/AIDS Who Smoke

Participants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS).

Group Type: EXPERIMENTAL

iTBS

Intervention Type: DEVICE

1800 pulses of iTBS

TMS

Intervention Type: DEVICE

MagVenture MagPro x100 device. This will be used as the comparator.

Interventions

iTBS

1800 pulses of iTBS

Intervention Type: DEVICE

TMS

MagVenture MagPro x100 device. This will be used as the comparator.

Intervention Type: DEVICE

Other Intervention Names

Intermittent theta burst stimulation; Transcranial magnetic stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gopalkumar Rakesh

OTHER

Sponsor Role: lead

Responsible Party

Gopalkumar Rakesh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gopalkumar Rakesh, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, University of Kentucky

Locations

245 Fountain Court

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

64473

Identifier Type: -

Identifier Source: org_study_id