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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking; Hiv
• Intervention / Treatment: Device: TBS; Device: Sham TMS

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	Changes in functional connectivity on a functional MRI brain scan.	on Day 1 of study

Collaborators and Investigators

• Sponsor: Gopalkumar Rakesh
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General 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.

Study record dates

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: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Behavior; Smoking; Tobacco Use; Acquired Immunodeficiency Syndrome; Tobacco Smoking
• 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