HivNCT05295953
Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
A study testing TBS in people with Hiv and Tobacco Smoking, run by Gopalkumar Rakesh at 2 sites in United States.
Trial summary
To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hiv, Tobacco Smoking
- What is being tested?
- TBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2022to 31 Jul 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients enrolled in the Bluegrass Clinic
- 18-60 years of age
- Male or female gender
- Able to read, understand and communicate in English
- Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic
- Willing and able to abstain from drug use other than Suboxone
- Exhaled breath on day of study carbon monoxide (CO) < 5 ppm
- Stabilized on maintenance buprenorphine if having comorbid opioid use disorder.
Who cannot join
- Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel.
- Previous adverse effect with TMS.
- Sub-threshold consistency while performing behavioral tasks.
- Failure to show baseline attentional bias to smoking versus neutral cues.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
245 Fountain Court
Lexington, Kentucky, 40513
University of Kentucky
Lexington, Kentucky, 40513
About this study
To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.
Read the detailed description
The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. 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 morbidity, 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. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.
- Conditions
- Hiv, Tobacco Smoking
- Being tested
- TBS, Sham TMS
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBSDevice
Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.
Sham TMSDevice
Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
| Study group | Role | What they receive |
|---|---|---|
| TBS (Theta burst stimulation) | Active comparator | Four sessions of TBS in one day Receives: Device: TBS |
| Sham TMS | Placebo comparator | Four sessions of sham TMS Receives: Device: Sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaze Fixation on Smoking Cues
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Measured: On Day 1 of the study
Gaze Fixation on Smoking Cues
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Measured: On Day 1 of the study after intervention
Craving for Cigarettes
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.
Measured: On day one of the study.
Craving for Cigarettes
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.
Measured: Immediately after intervention (sessions of TBS or sham TMS) on day 1
Secondary outcomes (1)
Number of Participants Showing Functional Connectivity Changes
Changes in functional connectivity on a functional MRI brain scan.
Measured: on Day 1 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active group and sham group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gopalkumar Rakesh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Gopalkumar Rakesh, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295953
- Sponsor's protocol ID
- 70889
- Other IDs
- 5P30CA177558-10
- Status last verified
- Oct 2025
- First submitted
- 10 Feb 2022
- Last updated
- 22 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rakesh G, Alcorn JL 3rd, Khanal R, Himelhoch SS, Rush CR. Comparing cigarette-cue attentional bias between people with HIV/AIDS and people with opioid use disorder who smoke. Health Psychol Behav Med. 2023 Sep 7;11(1):2255028. doi: 10.1080/21642850.2023.2255028. eCollection 2023.
PubMed 37693107
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
- ClinicalTrials.gov ID
- NCT05295953
- Acronym / sponsor ID
- 70889
- Conditions
- Hiv, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Gopalkumar RakeshUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Posted 22 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.
Detailed description
The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. 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 morbidity, 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. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Active group and sham group
| Arm | Type | Receives |
|---|---|---|
| TBS (Theta burst stimulation) | Active comparator | Device: TBSFour sessions of TBS in one day |
| Sham TMS | Placebo comparator | Device: Sham TMSFour sessions of sham TMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients enrolled in the Bluegrass Clinic
- 18-60 years of age
- Male or female gender
- Able to read, understand and communicate in English
- Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic
Key exclusion criteria (4 listed)
- Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel.
- Previous adverse effect with TMS.
- Sub-threshold consistency while performing behavioral tasks.
- Failure to show baseline attentional bias to smoking versus neutral cues.
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 |
|---|---|---|
| TBSFour sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan. | Device | TBS (Theta burst stimulation) |
| Sham TMSFour sessions of sham TMS delivered using MagVenture B65 A/P coil. | Device | Sham TMS |
Primary outcome
Gaze Fixation on Smoking Cues
Time frame: On Day 1 of the study
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Gaze Fixation on Smoking Cues
Time frame: On Day 1 of the study after intervention
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Craving for Cigarettes
Time frame: On day one of the study.
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.
Craving for Cigarettes
Time frame: Immediately after intervention (sessions of TBS or sham TMS) on day 1
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.
1 secondary outcome
Number of Participants Showing Functional Connectivity Changes
Time frame: on Day 1 of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37693107Rakesh G, Alcorn JL 3rd, Khanal R, Himelhoch SS, Rush CR. Comparing cigarette-cue attentional bias between people with HIV/AIDS and people with opioid use disorder who smoke. Health Psychol Behav Med. 2023 Sep 7;11(1):2255028. doi: 10.1080/21642850.2023.2255028. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TBS in people with Hiv and Tobacco Smoking, run by Gopalkumar Rakesh at 2 sites 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 8 inclusion and 4 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 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 22 Oct 2025). 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?
Gaze Fixation on Smoking Cues (time frame: On Day 1 of the study). 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?
On the ClinicalTrials.gov record for NCT05295953, which also lists 1 linked publication.
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 22 Oct 2025.