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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04936594

Enrollment

Registered

2021-06-23

Start date

2021-05-24

Completion date

2021-11-24

Last updated

2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craving, HIV, Smoking Cessation

Keywords

Transcranial magnetic stimulation (TMS), Attentional bias, Conditioning

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

Interventions

DEVICEiTBS

1800 pulses of iTBS

DEVICETMS

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

All participants received iTBS (intermittent theta burst stimulation) first and sham subsequently but were blinded regarding treatment.

Intervention model description

Single blind within participant design

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking	baseline and immediately after intervention, approximately 4 hours	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
Change in Attentional Bias Sham Smoking	baseline and immediately after intervention, approximately 4 hours	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
Change in Attentional Bias iTBS Paraphernalia	baseline and immediately after intervention, approximately 4 hours	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
Change in Attentional Bias Sham Paraphernalia	baseline and immediately after intervention, approximately 4 hours	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

Secondary

Measure	Time frame	Description
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS	baseline and immediately after intervention, approximately 4 hours	Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving.
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham	baseline and immediately after intervention, approximately 4 hours	Craving measured using TCQ-SF. The Tobacco Craving Questionnaire-short form (TCQ-SF) consists of 12 items rated on a visual analogue scale from 0 to 84 with a higher score equating to increased craving.

Other

Measure	Time frame	Description
Resting State Functional Connectiivity	Baseline	Measured in MRI scanner

Countries

United States

Participant flow

Pre-assignment details

A total of 9 participants were enrolled; however, 1 participant dropped out before the experimental sessions began.

Participants by arm

Arm	Count
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).	8
Total	8

Baseline characteristics

Characteristic	People Living With HIV/AIDS Who Smoke
Age, Continuous	42.88 years STANDARD_DEVIATION 3.45
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	5 Participants
Region of Enrollment United States	8 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	7 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 8
other Total, other adverse events	0 / 8
serious Total, serious adverse events	0 / 8

Outcome results

Primary

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