Using deep brain stimulation to treat severe addiction
HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders
NA · Centre for Addiction and Mental Health · NCT06973512
This study is testing if deep brain stimulation can help people with severe addiction who haven't found success with other treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06973512 on ClinicalTrials.gov |
What this trial studies
The HABITS Study aims to explore the effectiveness of deep brain stimulation (DBS) for individuals suffering from treatment-refractory substance use disorders (SUD). This innovative approach utilizes stereoelectroencephalography (SEEG) to personalize the stimulation targets and settings for each patient, addressing the unique neural networks involved in addiction. By combining DBS with a comprehensive drug craving provocation paradigm and advanced AI analysis, the study seeks to improve treatment outcomes for those who have not responded to traditional therapies. The study is designed to be minimally invasive and reversible, with a focus on enhancing the precision of treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25-65 with severe substance use disorders who have not responded to at least two evidence-based treatment modalities.
Not a fit: Patients with major medical co-morbidities or contraindications to neurosurgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for individuals struggling with severe substance use disorders.
How similar studies have performed: Other studies have shown promise for deep brain stimulation in treating various conditions, but this specific application for substance use disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult, Age 25-65 * Severe DSM-5 substance use disorder (SUD) as assessed by Structured Clinical Interview for DSM-5 (SCID-5) * Treatment refractory as evidenced by non-response to an adequate trial of ≥2 evidence-based treatment modalities for their substance use disorder in the most recent 3 years of illness, as determined by the study clinical team * Able to comply with study visit schedule and timeline * Stable housing and reliable transportation * Treatment-seeking (\>7 on a 0-10 readiness ruler and open to the end-of-treatment outcome of abstinence) * Capable of understanding and providing informed consent Exclusion Criteria: * Contraindications to neurosurgical interventions such as major medical co-morbidities, including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system failure, active infection or history of implant-related infections, immunocompromised state, or malignancy with \<5 years life expectancy * 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 * Cardiac pacemaker/defibrillator, or other implanted stimulator * Presence of epilepsy, stroke, or degenerative disorder of the nervous system * Serious problems with literacy, vision, or hearing
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health / Toronto Western Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Victor Addiction psychiatrist and scientist, MD, MSc
- Email: Victor.Tang@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Addiction, Substance Use Disorder, addiction, substance use disorder, deep brain stimulation, stereoelectroencephalography, biomarker, electrophysiology