Using deep brain stimulation to treat severe addiction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.