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NCT Number: NCT06830980

Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH

The purpose of this study is to learn more about how accelerated theta burst stimulation affects methamphetamine craving and brain activity. Theta burst stimulation is a unique transcranial magnetic stimulation (TMS) paradigm that is efficient and potent.

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Key information

Conditions

Methamphetamine Use Disorders HIV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The investigators will compare how two theta burst paradigms, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), compare with sham TMS in changing methamphetamine craving and brain activity. iTBS, cTBS, and sham TMS will be delivered in an accelerated fashion (two sessions daily, separated by 50 minutes). iTBS will be delivered to the left dorsolateral prefrontal cortex (left dorsolateral prefrontal cortex), and cTBS will be delivered to the frontal pole. A brain MRI scan will be done before and after the iTBS/cTBS/sham TMS sessions. The study involves four visits. Each visit will last three hours. Hence, participants will spend a total of 12 hours in the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults in the age group 18-65 years
  • Able to read and understand English
  • Able to provide informed consent
  • Diagnosed with HIV
  • History of current or previous Methamphetamine Use Disorder
  • Endorse craving for methamphetamine
  • Demonstrate an attentional bias for methamphetamine

Exclusion criteria

  • Traumatic brain injury
  • h/o seizure disorder
  • h/o or current diagnosis of schizophrenia
  • intracranial metal shrapnel
  • previous adverse effects with TMS
  • sub-threshold consistency while performing behavioral tasks
  • lack of attentional bias to methamphetamine cues
  • a positive pregnancy test for female participants
  • abnormal brain MRI

Treatment and study plan

intermittent theta burst stimulation (iTBS)

Device

iTBS is an excitatory TMS paradigm that delivers 1800 pulses to the left dlPFC. Participants will receive 2 iTBS sessions separated by 50 minutes.

Continuous theta burst stimulation (cTBS)

Device

cTBS is an inhibitory TMS paradigm that delivers 1800 pulses to the frontal pole. Participants will receive 2 iTBS sessions separated by 50 minutes.

Sham TMS

Device

Sham TMS delivered with the MagVenture B65 A/P coil

Primary outcomes

  1. Cue-induced methamphetamine craving

    Time frame: Baseline and before and after each TMS session up to 4 days

    Measured on the visual analog scale (VAS) Scored 0 to 100 with 0=no craving and 100=the most craving.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Garth, CRC

CONTACT

[email protected], [email protected]

859-382-7611

Sponsors and collaborators

Lead sponsor

Gopalkumar Rakesh

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

TMS (Transcranial Magnetic Stimulation) for Methamphetamine Use Disorder in People Living With HIV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Oct 24, 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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