rTMS for Suicidal Ideation in Opioid Users

Overseen By Taylor Ly

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Unstable medical condition, Pregnant, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests repetitive transcranial magnetic stimulation (rTMS), a non-invasive procedure using magnetic fields to stimulate nerve cells, to determine its effectiveness in reducing suicidal thoughts in individuals who use opioids. Researchers aim to discover whether this treatment can assist those struggling with opioid use and active suicidal thoughts. Participants should have a history of opioid use, depressive symptoms, and frequent suicidal thoughts. The trial includes two groups: one receiving real rTMS treatment and the other receiving a placebo (sham) treatment for comparison. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for opioid-related suicidal thoughts.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team for guidance.

What prior data suggests that rTMS is safe for treating suicidal ideation in opioid users?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally well-tolerated. Studies involving patients with opioid use disorder and major depression have tested rTMS to assess its impact on suicidal thoughts. These studies found that most patients manage the treatment well, experiencing only mild side effects like headaches or scalp discomfort. No serious side effects have been linked to rTMS in the available research. This suggests rTMS is a safe option for many people. However, individual reactions vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using repetitive Transcranial Magnetic Stimulation (rTMS) for suicidal thoughts in opioid users because it offers a non-invasive alternative to traditional treatments like medication and therapy. Unlike other treatments that can take weeks to show effects, rTMS has the potential to provide quicker relief by directly stimulating brain regions involved in mood regulation. Plus, it avoids the systemic side effects commonly associated with medications, making it a promising option for those who haven't found success with standard care.

What evidence suggests that rTMS could be an effective treatment for suicidal ideation in opioid users?

Research shows that repetitive Transcranial Magnetic Stimulation (rTMS) can significantly reduce symptoms of depression, anxiety, and suicidal thoughts. Studies have found that rTMS effectively treats major depressive disorder (MDD) and reduces cravings in individuals with opioid use disorder (OUD). In this trial, participants will receive either active rTMS or sham rTMS. For those with OUD who experience suicidal thoughts, rTMS has shown promise in improving their condition. Evidence suggests that patients tolerate rTMS well, and it can quickly help reduce suicidal thoughts. This makes rTMS a potentially effective treatment for individuals dealing with both opioid addiction and suicidal thoughts. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with active suicidal thoughts, enrolled in The Menninger Clinic, experiencing depression, and have used opioids. They must understand the study and consent to participate. Women can't be pregnant or nursing. Participants cannot have metal implants that interfere with MRI or TMS procedures.

Inclusion Criteria

You have previously participated in a trial called H-22611.

You understand the consent form, can provide your consent in writing, and agree to complete all study procedures.

You are eligible for TMS treatment, as long as you do not have any metal in your head or within 12 inches of the TMS coil.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 sessions of either active or sham rTMS targeting the OFC

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in functional connectivity and psychiatric symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)
• sham rTMS

Trial Overview The study tests if Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, affects brain connectivity related to compulsive behavior and mood control in opioid users with suicidal tendencies compared to sham (fake) treatment.

How Is the Trial Designed?

Group I: Active rTMS Experimental Treatment 1 Intervention

5 sessions of active rTMS

Group II: Sham rTMS Placebo Group 1 Intervention

5 sessions of sham rTMS

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Published Research Related to This Trial

In a pilot trial involving 22 participants with opioid use disorder undergoing methadone maintenance therapy, repetitive transcranial magnetic stimulation (rTMS) did not significantly reduce cravings or heroin use compared to a sham treatment.

However, rTMS was associated with significant improvements in depressive symptoms, impulse control, and attention, suggesting potential benefits for mental health aspects in individuals with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Add-on repetitive transcranial magnetic stimulation in patients with opioid use disorder undergoing methadone maintenance therapy. Tsai, TY., Wang, TY., Liu, YC., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) has shown effectiveness in reducing cravings for tobacco, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC), based on a review of eight studies.

Repeated sessions of high-frequency rTMS over the DLPFC may be particularly beneficial for decreasing smoking and alcohol consumption, suggesting that rTMS could be a promising treatment option for drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. Barr, MS., Farzan, F., Wing, VC., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) shows promise in reducing suicidal ideation (SI) in patients with treatment-resistant depression, particularly in uncontrolled trials where a significant decrease in SI scores was observed (effect size g = 0.692).

In randomized controlled trials, while a decrease in SI scores was noted (g = 0.158), the effect was not statistically significant, indicating that more research is needed to fully understand the efficacy of rTMS for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Repetitive Transcranial Magnetic Stimulation on Suicidal Ideation in Treatment-Resistant Depression: A Meta-Analysis. Mehta, S., Konstantinou, G., Weissman, CR., et al.[2022]

In a pilot study involving 18 participants with cocaine use disorder, high-frequency rTMS (10 Hz) significantly reduced cocaine-seeking behavior compared to baseline, indicating its potential as a treatment option.

No significant effects were observed in the low-frequency (1 Hz) or sham groups, suggesting that the efficacy of rTMS may depend on the frequency of stimulation applied to the prefrontal cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Magnetic Stimulation of Medial Prefrontal and Cingulate Cortices Reduces Cocaine Self-Administration: A Pilot Study. Martinez, D., Urban, N., Grassetti, A., et al.[2022]

An intensive rTMS protocol consisting of 25 sessions significantly improved depression symptoms in treatment-resistant patients, achieving a response rate of 64.52% and a remission rate of 51.61% by day 5.

The treatment was well tolerated and showed a remarkable 100% response rate for suicidal ideation, with an 87.09% remission rate at day 5, indicating its potential as a rapid and effective intervention for both military veterans and non-military patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive rTMS for treatment-resistant depression patients with suicidal ideation: An open-label study. Wang, Q., Huang, H., Li, D., et al.[2022]

A systematic review of 11 clinical trials involving 593 participants suggests that while repetitive Transcranial Magnetic Stimulation (TMS) effectively reduces depression, its specific impact on suicidal ideation remains uncertain.

A retrospective analysis of 43 veterans receiving TMS treatment showed significant decreases in suicidal thoughts, indicating that improvements in suicidality may occur independently of changes in depressive symptoms, highlighting the need for more targeted research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation to reduce suicidality - A review and naturalistic outcomes. Bozzay, ML., Primack, J., Barredo, J., et al.[2022]

In a study of 711 patients with depressive disorders treated with repetitive transcranial magnetic stimulation (rTMS), only one patient (0.1%) committed suicide during treatment, suggesting that rTMS does not increase suicide risk.

The analysis of 332 patients showed a significant reduction in suicidal ideation, with 47% experiencing improvement, indicating that rTMS may effectively reduce suicidal thoughts in patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-Suicidal Efficacy of Repetitive Transcranial Magnetic Stimulation in Depressive Patients: A Retrospective Analysis of a Large Sample. Abdelnaim, MA., Langguth, B., Deppe, M., et al.[2020]

In a study of 30 heroin-dependent individuals receiving 10 sessions of rTMS over one week, treatment significantly reduced cravings and withdrawal symptoms, indicating its efficacy in managing addiction.

The study found that rTMS altered the coupling between brain regions in the default mode network, particularly the left inferior parietal lobe, which correlated with reduced cravings, suggesting a potential mechanism for its anti-craving effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Default mode network mechanisms of repeated transcranial magnetic stimulation in heroin addiction. Jin, L., Yuan, M., Zhang, W., et al.[2023]

Transcranial magnetic stimulation (TMS) has been explored in 19 studies involving 316 adults for its potential to reduce drug cravings and use, particularly targeting the dorsolateral prefrontal cortex with high-frequency pulses.

While some studies showed promising results, such as decreased smoking and cocaine use, the treatment is still experimental, and the exact mechanisms and optimal parameters for rTMS in addiction treatment remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in the treatment of substance addiction. Gorelick, DA., Zangen, A., George, MS.[2022]

In a study of 55 individuals with treatment-resistant depression, low-frequency rTMS applied to the right dorsolateral prefrontal cortex showed potential to improve self-referential processing, leading to a more positive self-view after treatment.

Baseline measures of anticipatory reward sensitivity and negative self-referential processing were linked to higher depressive symptoms and suicidality, suggesting these factors could help predict treatment outcomes with rTMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-affective processes and suicidality in response to repetitive transcranial magnetic stimulation for treatment resistant depression. Terpstra, AR., Vila-Rodriguez, F., LeMoult, J., et al.[2023]

In a study of 35 heroin-dependent individuals, active rTMS targeting the left dorsolateral prefrontal cortex significantly reduced both spontaneous and cue-induced cravings for heroin after just one week of treatment.

The improvement in cravings was associated with enhanced coupling between the left DLPFC and the left parahippocampal gyrus, suggesting that rTMS may help restore normal brain network interactions involved in addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation modulates coupling among large-scale brain networks in heroin-dependent individuals: A randomized resting-state functional magnetic resonance imaging study. Jin, L., Yuan, M., Zhang, W., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) shows promise as a noninvasive treatment for substance use disorders (SUDs) like cocaine and opioid use disorders by inducing neuroplastic changes in the brain, which can help reduce cravings and drug use.

The field faces several 'known unknowns' that need to be addressed to optimize rTMS for SUDs, including selecting the right cortical targets, understanding subcortical circuit engagement, and determining the best treatment sequences, highlighting the need for collaborative research efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating cocaine and opioid use disorder with transcranial magnetic stimulation: A path forward. Steele, VR., Maxwell, AM.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40040511/

a pilot feasibility randomized controlled trial We piloted a randomized, double-blind, sham-controlled trial of bilateral rTMS for patients with OUD and MDD experiencing suicidality.

2. cambridge.org cambridge.org/core/journals/european-psychiatry/article/repetitive-transcranial-magnetic-stimulation-for-the-treatment-of-suicidality-in-opioid-use-disorder-a-pilot-feasibility-randomized-controlled-trial/A7436FEF074C4B5A9CA5569CD0F2EFBA

a pilot feasibility randomized controlled trial Evidence suggests rTMS is effective in treating MDD and suicidality and in reducing opioid cravings; thus, it is well-positioned to treat those ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S138824572500793X

Rapid relief of suicidal ideation via repetitive transcranial ... Repetitive transcranial magnetic stimulation significantly improves depressive, anxiety, and suicidal ideation symptoms. · Linear mixed-effect model confirms a ...

4. scholars.mssm.edu scholars.mssm.edu/en/publications/repetitive-transcranial-magnetic-stimulation-for-the-treatment-of

Repetitive transcranial magnetic stimulation for the treatment ... T1 - Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder. T2 - A pilot feasibility ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9120615/

Efficacy and Tolerability of Repetitive Transcranial ... The study showed that rTMS was effective and well-tolerated in reducing suicidal ideation and depression severity in patients with major mental disorders.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725006871

Repetitive transcranial magnetic stimulation frequency ... This exploratory study examined the impact of 1 Hz and 10 Hz TMS treatment on suicidal ideation in adolescents with major depressive disorder.

7. medrxiv.org medrxiv.org/content/10.1101/2025.10.02.25337151v1.full-text

Repetitive Transcranial Magnetic Stimulation in Substance ... Repetitive transcranial magnetic stimulation for the treatment of suicidality in opioid use disorder: a pilot feasibility randomized controlled ...

8. psychiatrist.com psychiatrist.com/jcp/rtms-and-suicidal-ideation-in-trd/

The Effect of Repetitive Transcranial Magnetic Stimulation ... Our findings suggest that rTMS may be an effective treatment for SI in individuals with treatment-resistant depression, although further investigation is ...