Actively Recruiting
HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): 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
165 weeks
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
Substance use disorder (SUD) or addiction to drugs/alcohol is a devastating disease. Over 40,000 overdose deaths have happened in Canada since 2016, 1 in 5 Canadians will have a SUD, and 70% of those with SUD continue to relapse, showing that we urgently need new treatments. The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit harmful substances. Over 250,000 people have received DBS, which is well-established for Parkinson's disease and has evidence of success in major depression and obsessive-compulsive disorder. DBS uses electricity to directly stimulate areas of the brain. However, for DBS to work effectively, it needs to be personalized to each individual, which will be pursued through stereoelectroencephalography (SEEG). DBS and SEEG are minimally invasive and reversible, with a low risk of side effects. SEEG started over 70 years ago to find seizure location in the brain of children and adults with epilepsy. It now has been used for major depression and chronic pain to guide DBS. It involves inserting electrodes temporarily across critical brain areas and monitoring patients for several days. SEEG can provide an understanding of where addiction and craving are in the brain to guide the placement of DBS electrodes and device settings that are optimal for a person. In the HABITS Study, 10 participants will receive DBS guided by SEEG and undergo 11 study visits. Individuals will first undergo detoxification with CAMH. Then, they will receive DBS and SEEG at Toronto Western Hospital, where they will stay for 1 to 2 weeks. Finally, they will be followed for a year, where they will receive standard psychiatric care. SUD causes heavy burdens on individuals, families, healthcare systems, and society. The HABITS Study promises to personalize DBS to treat those who are struggling with severe addiction.
CONDITIONS
Official 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 DSM-5 criteria using SCID-5
- Treatment resistant with failure to respond to at least two evidence-based treatments in the last 3 years
- Able to follow the study visit schedule and timeline
- Have stable housing and reliable transportation
- Seeking treatment with readiness score above 7 on a 0-10 scale and open to abstinence as a goal
- Able to understand and provide informed consent
You will not qualify if you...
- Major medical conditions that prevent neurosurgery, including uncontrolled high blood pressure, bleeding disorders, severe diabetes, major organ failure, active or past implant-related infections, weakened immune system, or cancer with less than 5 years expected survival
- Contraindications to MRI such as having implanted metal devices (e.g., pacemaker, neurostimulator, metal joints, clips) or severe claustrophobia
- Having a cardiac pacemaker, defibrillator, or other implanted stimulators
- History of epilepsy, stroke, or progressive nervous system disorders
- Serious difficulties with reading, vision, or hearing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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