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OpenTrials
Completed

NCT Number: NCT05295953

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

245 Fountain Court, Lexington, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TBS

Device

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 TMS

Device

Four sessions of sham TMS delivered using MagVenture B65 A/P coil.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. Number of Participants Showing Functional Connectivity Changes

    Time frame: on Day 1 of study

    Changes in functional connectivity on a functional MRI brain scan.

Sponsors and collaborators

Lead sponsor

Gopalkumar Rakesh

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 25, 2022
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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