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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Theta Burst Stimulation for meth addiction?

Research suggests that Theta Burst Stimulation (TBS) can reduce drug cravings in methamphetamine users, similar to its effects in reducing cravings for cocaine and nicotine. Studies have shown that TBS is as effective as other forms of brain stimulation, like repetitive transcranial magnetic stimulation (rTMS), in reducing cravings and drug use. ^{1 2 3 4 5}

Is transcranial magnetic stimulation (TMS) safe for humans?

Research shows that transcranial magnetic stimulation (TMS), including theta burst stimulation (TBS), is generally safe for humans. Some participants experienced mild side effects like headaches, and one person had a temporary neurological event, but overall, it was well-tolerated in studies involving people with methamphetamine and cocaine use disorders. ^{1 2 5 6 7}

How does the treatment Theta Burst Stimulation differ from other treatments for meth addiction?

Theta Burst Stimulation (TBS) is a unique form of transcranial magnetic stimulation that uses rapid bursts of magnetic pulses to target specific brain areas, potentially reducing cravings and improving cognitive function in methamphetamine users. Unlike traditional treatments, TBS is non-invasive and can be administered in shorter sessions, which may improve patient compliance. ^{1 2 5 6 7}

Research Team

Gopalkumar Rakesh, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

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 am between 18 and 65 years old.

Exclusion Criteria

I have a history of seizures.

Positive pregnancy test for female participants

History of or current diagnosis of schizophrenia

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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) 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Twice-Daily Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex Reduces Methamphetamine Craving: A Pilot Study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Intermittent Theta-Burst Stimulation as a Treatment for Cocaine Use Disorder: A Proof-of-Concept Study. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation of the Prefrontal Cortex in Cocaine Use Disorder: A Pilot Study. [2020]

4. Switzerland 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. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intermittent Theta Burst Stimulation vs. High-Frequency Repetitive Transcranial Magnetic Stimulation in the Treatment of Methamphetamine Patients. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Intermittent theta burst transcranial magnetic stimulation for methamphetamine addiction: A randomized clinical trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Intermittent theta burst stimulation to the left dorsolateral prefrontal cortex improves working memory of subjects with methamphetamine use disorder. [2023]