Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
2 other identifiers
interventional
4
1 country
2
Brief 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 subjects who are smokers with HIV/AIDS compared to sham stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Apr 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedResults Posted
Study results publicly available
October 22, 2025
CompletedOctober 22, 2025
October 1, 2025
2.3 years
February 10, 2022
August 1, 2025
October 6, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Number of Participants Showing Functional Connectivity Changes
on Day 1 of study
Study Arms (2)
TBS (Theta burst stimulation)
ACTIVE COMPARATORFour sessions of TBS in one day
Sham TMS
PLACEBO COMPARATORFour sessions of sham TMS
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients enrolled in the Bluegrass Clinic
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gopalkumar Rakeshlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
245 Fountain Court
Lexington, Kentucky, 40513, United States
University of Kentucky
Lexington, Kentucky, 40513, United States
Related Publications (1)
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.
PMID: 37693107DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gopalkumar Rakesh MD
- Organization
- University of Kentucky, Lexington
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Participant will not know whether they receive active or sham TMS
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 25, 2022
Study Start
April 1, 2022
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
October 22, 2025
Results First Posted
October 22, 2025
Record last verified: 2025-10