Actively Recruiting
HABITS Study: Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders
Led by Centre for Addiction and Mental Health · Updated on 2026-04-29
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre for Addiction and Mental Health
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring deep brain stimulation (DBS) guided by stereoelectroencephalography (SEEG) for people with severe substance use disorder (SUD) who have not responded to other treatments. SUD is a serious condition causing many deaths and relapses, highlighting the need for new therapies. DBS has been used successfully for Parkinson's disease, depression, and obsessive-compulsive disorder, and this study aims to personalize DBS for addiction by using SEEG to identify brain areas related to craving. In this study, 10 participants will receive DBS guided by SEEG. After detoxification, patients will undergo DBS and SEEG implantation at Toronto Western Hospital, staying for 1 to 2 weeks. SEEG involves temporarily placing electrodes in the brain to monitor activity and guide the best DBS electrode placement and settings. Following this, participants will be monitored and receive standard psychiatric care for one year. Participants will attend 11 study visits including assessments of substance use, cravings, mood, anxiety, and brain activity using the implanted electrodes. Researchers will track treatment-related side effects, recruitment success, and adherence over 12 months. Urine tests, self-reports, and questionnaires will help measure outcomes. The study aims to better understand and improve personalized DBS treatment for those with treatment-resistant SUD.
CONDITIONS
Brief Title
HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 25 to 65 years
- Severe substance use disorder diagnosed by Structured Clinical Interview for DSM-5 (SCID-5)
- Treatment-resistant after trying two or more evidence-based treatments in the past 3 years
- Able to follow study visit schedule and timelines
- Have stable housing and reliable transportation
- Seeking treatment and motivated to quit (score >7 on readiness ruler)
- Able to understand and provide informed consent
You will not qualify if you...
- Medical conditions that make neurosurgery unsafe, such as uncontrolled hypertension, severe diabetes, major organ failure, active infection, or recent cancer
- Cannot have MRI due to implanted metal devices or claustrophobia
- Having a cardiac pacemaker, defibrillator, or other implanted stimulator
- History of epilepsy, stroke, or nervous system degenerative disease
- Serious problems with literacy, vision, or hearing that affect participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive deep brain stimulation guided by stereoelectroencephalography to target neural networks implicated in substance use disorder.
Multiple visits for device implantation and stimulation adjustments during the study period
Duration - Up to 12 months after implantation
Participants are monitored for treatment-related adverse events and changes in substance use and symptoms after receiving deep brain stimulation.
Regular follow-up visits throughout the 12-month study period
Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health / Toronto Western Hospital
Toronto, Ontario, Canada, 399 Bathurst St
Actively Recruiting
Research Team
V
Victor Addiction psychiatrist and scientist, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here