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

NCT04936594 | Completed Results FDA Device

• 1 other identifier: 64473
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; HIV; Craving

Keywords

Transcranial magnetic stimulation (TMS); Attentional bias; Conditioning

Outcome Measures

Primary Outcomes (4)

• Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking

  Cues Encompassing People Smoking Cigarettes. Measured after iTBS using visual probe task administered (adapted for smoking images) on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

  baseline and immediately after intervention, approximately 4 hours

• Change in Attentional Bias Sham Smoking

  Cues Encompassing People Smoking Cigarettes. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of smoking and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

  baseline and immediately after intervention, approximately 4 hours

• Change in Attentional Bias iTBS Paraphernalia

  Cues Encompassing Cigarette Paraphernalia. Measured after iTBS using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

  baseline and immediately after intervention, approximately 4 hours

• Change in Attentional Bias Sham Paraphernalia

  Cues Encompassing Cigarette Paraphernalia. Measured after sham using visual probe task (adapted for smoking images) administered on a computer and eye tracker. Images of cigarette paraphernalia and a matched neutral cue were presented on a laptop screen, 3 cm apart. Upon offset of the image pairs, a visual probe (X) appeared on either the left side or right side of the screen, in the same location as one of the previously presented images. Attentional bias is quantified using fixation time on cigarette and neutral cues, via an eye tracker in milliseconds

  baseline and immediately after intervention, approximately 4 hours

Secondary Outcomes (2)

• Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS

  baseline and immediately after intervention, approximately 4 hours

• Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham

  baseline and immediately after intervention, approximately 4 hours

Other Outcomes (2)

• Resting State Functional Connectiivity

  Baseline

• Resting State Functional Connectiivity

  Four hours from baseline

Study Arms (1)

People Living with HIV/AIDS Who Smoke

EXPERIMENTAL

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

Device: iTBS; Device: TMS

Interventions

iTBS DEVICE

1800 pulses of iTBS

Also known as: Intermittent theta burst stimulation

People Living with HIV/AIDS Who Smoke

TMS DEVICE

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

Also known as: Transcranial magnetic stimulation

People Living with HIV/AIDS Who Smoke

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gopalkumar Rakesh: lead

Study Sites (1)

245 Fountain Court

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Gopalkumar Rakesh
• Organization: University of Kentucky

gopalkumar.rakesh@uky.edu

859-562-2348

Study Officials

• Gopalkumar Rakesh, MD

  Assistant Professor, University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants received iTBS (intermittent theta burst stimulation) first and sham subsequently but were blinded regarding treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single blind within participant design

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 23, 2021
• Study Start: May 24, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: July 13, 2023
• Results First Posted: July 13, 2023

Record last verified: 2023-06

Locations

US (1)