TBS (Theta burst stimulation) for Tobacco

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tobacco+3 More
TBS - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Hiv
  • Tobacco

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: On Day 1 of the study after intervention

Day 1
Craving for cigarettes
Functional connectivity changes
Day 1
Gaze Fixation on Smoking Cues

Trial Safety

Trial Design

2 Treatment Groups

TBS (Theta burst stimulation)
1 of 2
Sham TMS
1 of 2
Active Control
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: TBS (Theta burst stimulation) · Has Placebo Group · N/A

TBS (Theta burst stimulation)
Device
ActiveComparator Group · 1 Intervention: TBS · Intervention Types: Device
Sham TMS
Device
PlaceboComparator Group · 1 Intervention: Sham TMS · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: on day 1 of the study after intervention

Who is running the clinical trial?

Gopalkumar RakeshLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to follow the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic.
You are willing and able to abstain from drug use other than Suboxone.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.