Deep Brain Stimulation for Addiction

(HABITS Trial)

Overseen By Victor Addiction psychiatrist and scientist, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Uncontrolled hypertension, Severe diabetes, Epilepsy, others

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

Compensation: Varies

Number of Visits: 11

Duration: 1-2 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals struggling with severe addiction to drugs or alcohol. It employs deep brain stimulation (DBS), which sends tiny electrical pulses to specific brain areas to reduce cravings and control addiction. The trial personalizes DBS using stereoelectroencephalography (SEEG) to map where the treatment should focus in the brain. It targets individuals who have tried at least two other treatments in the past three years without success and are highly motivated to quit. Participants will undergo detox, receive the treatment, and be monitored for a year. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in addiction treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since participants will undergo detoxification, it's possible that some medications might need to be adjusted or stopped. It's best to discuss this with the study team.

What prior data suggests that deep brain stimulation guided by stereoelectroencephalography is safe for treating addiction?

Research has shown that deep brain stimulation (DBS) is generally well-tolerated. Over 250,000 people, primarily with Parkinson's disease, have used it successfully, and it has also treated major depression and obsessive-compulsive disorder. DBS uses electrical signals to stimulate specific brain areas directly. When performed correctly, it carries a low risk of side effects and can be reversed if necessary.

Stereoelectroencephalography (SEEG), which guides DBS, has been in use for over 70 years. It identifies seizure areas in epilepsy patients and is now also applied to treat depression and chronic pain. SEEG is minimally invasive, requiring only small openings in the skin or body, avoiding major surgery. It aids doctors in placing DBS electrodes more accurately, enhancing safety and effectiveness.

In one study using SEEG to guide DBS, researchers found this method to be safe and practical. This suggests that combining SEEG and DBS could be a promising treatment for severe addiction, with a strong emphasis on participant safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Brain Stimulation (DBS) for addiction because it offers a completely different approach compared to traditional treatments like medication and behavioral therapy. Unlike these standard methods, DBS directly targets specific brain circuits involved in addictive behaviors by using implanted electrodes. This precise intervention has the potential to modify brain activity patterns and reduce cravings, offering hope for those who haven't found success with existing therapies. By focusing on altering brain function at its core, DBS could revolutionize the way we treat addiction.

What evidence suggests that deep brain stimulation guided by stereoelectroencephalography is effective for addiction?

Research has shown that deep brain stimulation (DBS) can greatly benefit people with substance use disorders (SUD). One study reported that participants experienced an average improvement of 59.6% in their SUD symptoms after receiving DBS treatment. DBS can reduce cravings and enhance the quality of life for those struggling with addiction. This technique uses electrical signals to stimulate specific parts of the brain and has been successfully used for other conditions like Parkinson's disease and depression. In this trial, all participants will receive DBS guided by stereoelectroencephalography (SEEG), which may enhance the treatment's effectiveness for addiction. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The HABITS Study is for individuals with severe substance use disorders who have not successfully quit using harmful substances despite trying other treatments. Participants will undergo detoxification and must be willing to stay at a hospital for 1-2 weeks, followed by a year of psychiatric care.

Inclusion Criteria

Severe DSM-5 substance use disorder (SUD) as assessed by Structured Clinical Interview for DSM-5 (SCID-5)

I am between 25 and 65 years old.

Able to comply with study visit schedule and timeline

Exclusion Criteria

Cardiac pacemaker/defibrillator, or other implanted stimulator

Serious problems with literacy, vision, or hearing

Contraindications for MRI, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Detoxification

Participants undergo detoxification with CAMH

1-2 weeks

Inpatient stay at CAMH

Treatment

Participants receive deep brain stimulation (DBS) guided by stereoelectroencephalography (SEEG) at Toronto Western Hospital

1-2 weeks

Inpatient stay at Toronto Western Hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, receiving standard psychiatric care

12 months

11 study visits

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation Guided By Stereoelectroencephalography

Trial Overview This pilot trial tests deep brain stimulation (DBS) guided by stereoelectroencephalography (SEEG) in treating addiction. DBS uses electrical impulses to stimulate the brain, while SEEG helps personalize treatment by mapping areas related to addiction.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

There will be one arm where everyone will receive DBS

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449586/

Deep brain stimulation for substance use disorder The results showed that DBS treatment resulted in a significant improvement in the clinical SUD scales of patients, with an average improvement of 59.6%.

2. nature.com nature.com/articles/s41398-024-03060-1

A systematic review of deep brain stimulation for substance ... For treatment-refractory addictions DBS use seems limited to reducing cravings with a satisfactory degree of success, yet not clinically ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X18303085

Long-term results after deep brain stimulation of nucleus ... Decreased cravings for drug use, improved quality of life and alleviated mental disorders were observed. •. Simultaneous DBS of NAc and ALIC appears to be safe, ...

4. scienceopen.com scienceopen.com/hosted-document?doi=10.15212/npt-2024-0003

Deep Brain Stimulation for Substance Use Disorder In most experimental results and data, DBS has been observed to specifically mitigate addiction without impinging on other rewarding behaviors.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6329833/

Deep brain stimulation for the treatment of drug addiction - PMC Deep brain stimulation (DBS) may be an effective treatment. The past 15 years have seen numerous animal DBS studies for addiction to various drugs of abuse.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06973512?utm_source=trialradar

Pilot Trial of Deep Brain Stimulation Guided By ... The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit ...

7. medrxiv.org medrxiv.org/content/10.1101/2025.04.17.25325961v1

Stereo-encephalography-guided multi-lead deep brain ... We anticipate that sEEG to guide selection of multi-nodal targets for DBS will be safe, feasible and result in clinically meaningful ...

8. stanfordhealthcare.org stanfordhealthcare.org/trials/s/NCT05623306.html

SEEG-Guided DBS for OCD This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06973512

NCT06973512 | HABITS Study (Helping Addiction by ... Two critical barriers of DBS are 1) identifying optimal DBS electrode targets as many brain areas are implicated in addiction and 2) selecting the correct ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10783698/

Role of deep brain stimulation (DBS) in addiction disorders DBS shows significant promise for treating addiction disorders and has the potential to transform our understanding and treatment of addiction.