Trial results for a study investigating Accelerated Transcranial Magnetic Stimulation (TMS) for smoking cessation in people living with HIV/AIDS (PLWHA) were posted on ClinicalTrials.gov on 2025-10-22. The study enrolled 4 participants.
Background
People living with HIV (PLWH) often face a higher prevalence of tobacco smoking compared to the general population, which exacerbates existing health challenges and complicates HIV management. Smoking cessation is a critical health goal for PLWH, but traditional methods may have limited efficacy in this group due to various psychosocial and biological factors. Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique, has been explored as a potential intervention for addiction, including smoking cessation, by modulating neural circuits associated with craving and attentional bias towards smoking cues. Investigating such interventions is important for addressing the specific needs of PLWH who smoke.
Trial design
This completed study, designated as Phase NA, enrolled 4 participants with conditions including HIV and Tobacco Smoking. The trial aimed to demonstrate whether four sessions of Theta Burst Stimulation (TBS), a form of accelerated TMS, could improve attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. The intervention involved TBS applied to the left dorsolateral prefrontal cortex (DLPFC). The hypothesis was that TBS would significantly improve attentional bias and craving for smoking cues compared to neutral cues, relative to sham stimulation.
Key results
The trial reported several key measurements related to gaze fixation on smoking cues, craving for cigarettes, and functional connectivity changes:
- Gaze Fixation on Smoking Cues (milliseconds):
- For the TBS (Theta Burst Stimulation) group, a mean of 320.19 milliseconds (Standard Deviation 234.83) was observed.
- For the Sham TMS group, a mean of 152.60 milliseconds (Standard Deviation NA) was observed.
- Another measurement for the TBS (Theta Burst Stimulation) group showed a mean of 221.75 milliseconds (Standard Deviation 94.24).
- Another measurement for the Sham TMS group showed a mean of 120.50 milliseconds (Standard Deviation NA).
- Craving for Cigarettes (units on a scale):
- For the TBS (Theta Burst Stimulation) group, a mean of 58 units on a scale (Standard Deviation 5.66) was observed.
- For the Sham TMS group, a mean of 50 units on a scale (Standard Deviation NA) was observed.
- Another measurement for the TBS (Theta Burst Stimulation) group showed a mean of 51 units on a scale (Standard Deviation 1.41).
- Another measurement for the Sham TMS group showed a mean of 28 units on a scale (Standard Deviation NA).
- Number of Participants Showing Functional Connectivity Changes (Participants):
- For the TBS (Theta Burst Stimulation) group, 2 participants showed changes.
- For the Sham TMS group, 1 participant showed changes.
What this means
The posted results provide preliminary data on the effects of accelerated TMS on attentional bias and craving in a small cohort of HIV-positive smokers. Given the enrollment of only 4 participants, these findings are exploratory and should be interpreted with caution. The measurements offer initial insights into how TBS might influence specific markers related to smoking behavior in this vulnerable population. However, without statistical analyses or larger sample sizes, no definitive conclusions about the efficacy or comparative benefits of TBS versus sham stimulation can be drawn. These results may inform the design of future, larger-scale studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05295953, titled "Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)", were posted on 2025-10-22 on clinicaltrials.gov.