Transcranial Magnetic Stimulation for Meth Addiction

Recruiting at 1 trial location

Overseen By Natalya Means, CRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gopalkumar Rakesh

Disqualifiers: Traumatic brain injury, Seizure disorder, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how theta burst stimulation, a type of transcranial magnetic stimulation (TMS), affects cravings and brain activity in people who use methamphetamine. TMS is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain. Participants will be divided into groups to receive either real or sham (placebo) TMS on different days for comparison. The trial seeks individuals who have used methamphetamine, experience cravings, and are living with HIV. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could lead to new treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this transcranial magnetic stimulation is safe for meth addiction?

Research has shown that theta burst stimulation, a type of brain stimulation, has been tested in people with methamphetamine addiction. Studies found it to be generally well-tolerated. Most participants experienced only mild side effects, such as headaches or slight discomfort at the stimulation site. These effects were temporary and resolved on their own.

In these studies, no serious side effects were linked to the treatment. This suggests that theta burst stimulation is relatively safe for humans, at least in the short term. However, since this information comes from earlier research, anyone considering joining a trial should discuss potential risks with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for meth addiction because it offers a unique, non-invasive way to potentially alter brain activity patterns associated with addiction. Unlike standard treatments like behavioral therapy or medication-assisted therapy, TMS targets specific brain areas using magnetic fields, which may help reduce cravings more directly. Specifically, the use of Theta Burst Stimulation (TBS) is promising because it can deliver results quickly, potentially in just a few sessions, compared to the longer timeframes needed for traditional therapies. This innovative approach could provide a new avenue for treating meth addiction with fewer side effects and a more targeted mechanism of action.

What evidence suggests that theta burst stimulation is effective for meth addiction?

Research has shown that theta burst stimulation (TBS), a type of brain stimulation, can help reduce cravings for methamphetamine. In this trial, participants will be divided into groups to receive either actual TBS or sham TMS on various days. One study found that TBS reduced cravings triggered by certain cues more effectively than a fake treatment. Another study demonstrated that TBS improved thinking skills and sleep quality in people with severe methamphetamine addiction. Additional research found that more frequent use of TBS led to a significant reduction in cravings. Overall, these findings suggest TBS could effectively manage methamphetamine addiction. ^{1 2 3 4 6}

Who Is on the Research Team?

Gopalkumar Rakesh, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-65 with HIV who crave methamphetamine and have a history of Meth Use Disorder. It's not for those with seizure disorders, schizophrenia, brain injuries, intracranial metal, past bad reactions to TMS, or inconsistent task performance.

Inclusion Criteria

Able to read and understand English

Able to provide informed consent

I have been diagnosed with HIV.

Exclusion Criteria

I have a history of seizures.

Positive pregnancy test for female participants

History of or current diagnosis of schizophrenia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive TMS sessions, including iTBS and cTBS, over 4 days with two sessions daily

1 week

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Theta Burst Stimulation

Trial Overview The study tests how different types of theta burst stimulation (TMS), including intermittent (iTBS) and continuous (cTBS), affect meth cravings and brain activity in people living with HIV compared to a sham TMS procedure.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 3 Interventions

Group 3 will receive sham TMS on day 2 and actual TMS (iTBS and cTBS) on days 3 and 4.

Group II: Group 2 Experimental Treatment 3 Interventions

Group 2 will receive actual TMS (iTBS and cTBS) on days 2 and 4 and sham TMS on day 3.

Group III: Group 1 Experimental Treatment 3 Interventions

Group 1 will receive actual TMS (iTBS and cTBS) on days 2 and 3 and sham TMS on day 4.

Who Is Running the Clinical Trial?

Gopalkumar Rakesh

Lead Sponsor

Trials

6

Recruited

110+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Intermittent theta burst stimulation (iTBS) applied over the dorsolateral prefrontal cortex (DLPFC) significantly reduced craving for methamphetamine and improved cognitive function and sleep quality in 126 participants with severe methamphetamine use disorder over a four-week period.

The study suggests that rTMS is a promising and safe treatment option for methamphetamine use disorder, indicating the need for further large-scale trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial. Su, H., Chen, T., Jiang, H., et al.[2021]

A proof-of-concept study involving 19 individuals with cocaine use disorder showed that administering intermittent theta-burst stimulation (iTBS) to the left dorsolateral prefrontal cortex was well-tolerated and safe, even in participants actively using cocaine.

Participants who completed at least 26 of the 30 iTBS sessions reduced their weekly cocaine use by 78% in spending and 70% in frequency, indicating that iTBS may effectively modulate addiction-related circuits and reduce substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study. Steele, VR., Maxwell, AM., Ross, TJ., et al.[2020]

Intermittent theta-burst stimulation (iTBS) significantly improved working memory accuracy, reaction time, and discrimination ability in 40 individuals with methamphetamine use disorder compared to sham treatment over 10 days.

The study also found that iTBS reduced resting-state delta power in the left prefrontal region, suggesting a potential biological mechanism linked to cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent theta burst stimulation to the left dorsolateral prefrontal cortex improves working memory of subjects with methamphetamine use disorder. Zhang, Y., Ku, Y., Sun, J., et al.[2023]

Intermittent theta burst stimulation (iTBS) of the prefrontal cortex has shown effects on reducing cocaine craving and consumption that are comparable to traditional high-frequency rTMS (15 Hz) in a study of 25 treatment-seeking cocaine addicts.

Both iTBS and 15 Hz rTMS demonstrated similar safety and tolerability profiles, with low dropout rates, suggesting that iTBS could be a more efficient treatment option due to its shorter duration (3 minutes) compared to the 15-minute standard protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Cocaine Use Disorder: A Pilot Study. Sanna, A., Fattore, L., Badas, P., et al.[2020]

In a study involving 12 nicotine-dependent individuals, theta burst stimulation (TBS) applied to the right inferior frontal gyrus (r.IFG) significantly improved inhibitory control during tasks requiring self-control, indicating its potential as a treatment for nicotine addiction.

The study found that excitatory TBS (iTBS) enhanced inhibitory control, while inhibitory TBS (cTBS) impaired it, suggesting that non-invasive brain stimulation can modulate cognitive functions related to substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissociable Effects of Theta-Burst Repeated Transcranial Magnetic Stimulation to the Inferior Frontal Gyrus on Inhibitory Control in Nicotine Addiction. Newman-Norlund, RD., Gibson, M., McConnell, PA., et al.[2020]

Intermittent theta burst stimulation (iTBS) over the left DLPFC and continuous theta burst stimulation (cTBS) over the right DLPFC significantly reduced cue-induced craving in abstinent methamphetamine-dependent subjects, indicating their potential efficacy as treatments for addiction.

The study involved 83 participants and showed that while iTBS had higher self-reported adverse effects initially, both stimulation methods were feasible and tolerable, suggesting a promising approach to reduce craving with shorter treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. Zhao, D., Li, Y., Liu, T., et al.[2023]

Intermittent theta burst stimulation (iTBS) and conventional 10 Hz repetitive transcranial magnetic stimulation (rTMS) showed similar effectiveness in reducing drug cravings and improving withdrawal symptoms in 20 male patients with methamphetamine use disorder (MAUD) after 12 treatments.

Both treatment methods were effective, suggesting that iTBS could be a viable alternative to 10 Hz rTMS, potentially enhancing the accessibility and cost-effectiveness of treatment for MAUD, although further large-scale studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation vs. High-Frequency Repetitive Transcranial Magnetic Stimulation in the Treatment of Methamphetamine Patients. Liu, Q., Sun, H., Hu, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11974796/

Theta Burst Stimulation in Patients With Methamphetamine ... The results of the random effects meta-analysis suggest iTBS was more effective in reducing cue-induced methamphetamine cravings than sham iTBS ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0924977X19318887

Intermittent theta burst transcranial magnetic stimulation for ... iTBS improved cognitive function in patients with severe methamphetamine use disorder. •. iTBS improved sleep quality in patients with severe methamphetamine ...

3. tandfonline.com tandfonline.com/doi/abs/10.1080/10550887.2025.2541165

Theta burst stimulation (TBS) in methamphetamine use ... Two additional RCTs without sham control arms were reviewed, and one demonstrated a significant reduction in craving following accelerated iTBS.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06372288

Theta Burst TMS for Treatment of Methamphetamine Use ... This study will test whether a specific type of TMS (intermittent theta burst) over the forehead can produce a reduction in things that may prompt you to want ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.842947/full

Intermittent Theta Burst Stimulation vs. High-Frequency ... Results: The results showed that iTBS and 10 Hz treatment had similar effectiveness in reducing cue-induced craving in male addicts for MA. Both ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11080215/

Pilot study with randomised control of dual site theta burst ... ... safety and preliminary efficacy data ... stimulation, Theta burst stimulation, Dorsolateral prefrontal cortex, Orbitofrontal cortex, Addiction ...