Status:
RECRUITING
HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Addiction
Substance Use Disorder (SUD)
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Deep brain stimulation (DBS) is a promising treatment for substance use disorder (SUD) as it can precisely target and modulate aberrant disease-implicated neural networks. It has the unique ability to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06973512
Start Date
November 1 2024
End Date
January 1 2028
Last Update
May 25 2025
Active Locations (1)
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1
Centre for Addiction and Mental Health / Toronto Western Hospital
Toronto, Ontario, Canada, 399 Bathurst St