HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · May 7, 2025

Keywords

ClinConnect Summary

The HABITS Study is a clinical trial designed to explore a new treatment approach for people struggling with severe substance use disorders (SUD) who have not found success with traditional therapies. The study focuses on a method called deep brain stimulation (DBS), which uses small electrical impulses to help regulate brain activity related to addiction. To make this treatment as effective as possible for each individual, the researchers will use a technique called stereoelectroencephalography (SEEG) to map brain areas involved in cravings and addiction, allowing for personalized treatment.

To participate in the HABITS Study, individuals must be between the ages of 25 and 65 and have a severe substance use disorder that hasn't responded to at least two different treatment approaches within the last three years. Participants can expect to undergo a detoxification process followed by a stay in the hospital for 1 to 2 weeks, during which they will receive DBS and SEEG. After that, they will be monitored for a year while receiving standard psychiatric care. The study aims to find new and effective ways to help those severely affected by addiction, providing hope for improved treatment options.

Gender

ALL

Eligibility 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