Smoking CessationNCT04936594
TMS for Smoking Cessation in PLWHA Cessation in People Living With HIV/AIDS (PLWHA)
A study testing iTBS and TMS in people with Smoking Cessation and HIV, run by Gopalkumar Rakesh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, HIV, Craving
- What is being tested?
- iTBS and TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
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.
Read the 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
- Being tested
- iTBS, TMS
- Keywords
- Transcranial magnetic stimulation (TMS), Attentional bias, Conditioning
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
Also called Intermittent theta burst stimulation
1800 pulses of iTBS
TMSDevice
Also called Transcranial magnetic stimulation
MagVenture MagPro x100 device. This will be used as the comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: iTBS; Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and immediately after intervention, approximately 4 hours
Secondary outcomes (2)
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS
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.
Measured: baseline and immediately after intervention, approximately 4 hours
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham
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.
Measured: baseline and immediately after intervention, approximately 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start24 May 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single blind within participant design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gopalkumar Rakesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gopalkumar Rakesh, University of Kentucky
- Investigators
- Gopalkumar Rakesh, MD, Principal investigator, Assistant Professor, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936594
- Sponsor's protocol ID
- 64473
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2021
- Last updated
- 13 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
- ClinicalTrials.gov ID
- NCT04936594
- Acronym / sponsor ID
- 64473
- Conditions
- Smoking Cessation, HIV, Craving
- Keywords
- Transcranial magnetic stimulation (TMS), Attentional bias, Conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Gopalkumar RakeshUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Posted 13 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single blind within participant design
| Arm | Type | Receives |
|---|---|---|
| People Living with HIV/AIDS Who Smoke | Experimental | Device: iTBS, Device: TMSParticipants will be people living with HIV/AIDS who smoke. They will receive two interventions: iTBS and a sham comparator (TMS). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTBSAlso: Intermittent theta burst stimulation1800 pulses of iTBS | Device | People Living with HIV/AIDS Who Smoke |
| TMSAlso: Transcranial magnetic stimulationMagVenture MagPro x100 device. This will be used as the comparator. | Device | People Living with HIV/AIDS Who Smoke |
Primary outcome
Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) iTBS
Time frame: baseline and immediately after intervention, approximately 4 hours
Change in Tobacco Craving Questionnaire Short Form (TCQ-SF) Sham
Time frame: baseline and immediately after intervention, approximately 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopalkumar Rakesh, MD principal investigator
Assistant Professor, University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS and TMS in people with Smoking Cessation and HIV, run by Gopalkumar Rakesh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Attentional Bias iTBS (Intermittent Theta Burst Stimulation) Smoking (time frame: baseline and immediately after intervention, approximately 4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.