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

October 6, 2025 updated by: Gopalkumar Rakesh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • University of Kentucky
      • Lexington, Kentucky, United States, 40513
        • 245 Fountain Court

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Potential participants will be

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TBS (Theta burst stimulation)
Four sessions of TBS in one day
Device: TBS
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.
Placebo Comparator: Sham TMS
Four sessions of sham TMS
Device: Sham TMS
Four sessions of sham TMS delivered using MagVenture B65 A/P coil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On Day 1 of the study
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
On Day 1 of the study after intervention
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.
On day one of the study.
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.
Immediately after intervention (sessions of TBS or sham TMS) on day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Showing Functional Connectivity Changes
Time Frame: on Day 1 of study
Changes in functional connectivity on a functional MRI brain scan.
on Day 1 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gopalkumar Rakesh

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 6, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70889
  • 5P30CA177558-10 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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