Transcranial Magnetic Stimulation for Methamphetamine Use Disorder in PLWH

October 22, 2025 updated by: Gopalkumar Rakesh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.
Device: intermittent theta burst stimulation (iTBS)
iTBS is an excitatory TMS paradigm that delivers 1800 pulses to the left dlPFC. Participants will receive 2 iTBS sessions separated by 50 minutes.
Device: continuous theta burst stimulation (cTBS)
cTBS is an inhibitory TMS paradigm that delivers 1800 pulses to the frontal pole. Participants will receive 2 iTBS sessions separated by 50 minutes.
Device: Sham TMS
Sham TMS delivered with the MagVenture B65 A/P coil
Other: Group 2
Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.
Device: intermittent theta burst stimulation (iTBS)
iTBS is an excitatory TMS paradigm that delivers 1800 pulses to the left dlPFC. Participants will receive 2 iTBS sessions separated by 50 minutes.
Device: continuous theta burst stimulation (cTBS)
cTBS is an inhibitory TMS paradigm that delivers 1800 pulses to the frontal pole. Participants will receive 2 iTBS sessions separated by 50 minutes.
Device: Sham TMS
Sham TMS delivered with the MagVenture B65 A/P coil
Other: Group 3
Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.
Device: intermittent theta burst stimulation (iTBS)
iTBS is an excitatory TMS paradigm that delivers 1800 pulses to the left dlPFC. Participants will receive 2 iTBS sessions separated by 50 minutes.
Device: continuous theta burst stimulation (cTBS)
cTBS is an inhibitory TMS paradigm that delivers 1800 pulses to the frontal pole. Participants will receive 2 iTBS sessions separated by 50 minutes.
Device: Sham TMS
Sham TMS delivered with the MagVenture B65 A/P coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and before and after each TMS session up to 4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gopalkumar Rakesh

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Gopalkumar Rakesh, MD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 100353
  • UL1TR001998 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV

Clinical Trials on intermittent theta burst stimulation (iTBS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe