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

NCT ID: NCT06973512

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-01-01

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 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.

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 directly stimulate deep brain structures and deliver long-term electrical stimulation. DBS is minimally invasive, reversible, and non-ablative, with a minor risk of serious adverse events. DBS is well-established for movement disorders, with over 250,000 procedures performed, and has FDA breakthrough device status for major depression and OCD. A 2023 review of DBS for SUD demonstrated its tremendous promise, with an average clinical improvement of 60%. But with only approximately 50 patients with SUD receiving DBS worldwide, more studies are urgently required.

Although one of the strengths of DBS is its ability to be individualized to patients, doing so is difficult. Two critical barriers of DBS are 1) identifying optimal DBS electrode targets as many brain areas are implicated in addiction and 2) selecting the correct stimulation settings as many are possible and detecting immediate effects of settings is difficult (in contrast to movement disorders, such as immediate tremor cessation).

In the HABITS Study, we aim to address these shortcomings by using stereoelectroencephalography (SEEG), a comprehensive drug craving provocation paradigm, and a newly developed AI driven analysis pipeline. SEEG has been in use since the 1960s and is the gold standard for medication-resistant epilepsy, which involves the implantation of intracranial electrodes across the brain, providing continuous electrophysiological recordings for multiple days to identify seizure location. SEEG has been recently used to guide DBS for major depression and chronic pain.

By leveraging SEEG to elucidate an objective, predictive biomarker of addiction (e.g., craving), this can be used to better guide DBS target selection and stimulation setting to improve the effectiveness of DBS for patients with SUD.

Conditions

Addiction; Substance Use Disorder (SUD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

There will be one arm where everyone will receive DBS

Group Type: EXPERIMENTAL

deep brain stimulation and stereoelectroencephalography

Intervention Type: DEVICE

Deep brain stimulation guided by stereoelectroencephalography

Interventions

deep brain stimulation and stereoelectroencephalography

Deep brain stimulation guided by stereoelectroencephalography

Intervention Type: DEVICE

Other Intervention Names

deep brain stimulation; stereoelectroencephalography

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Victor Tang

Addiction Psychiatrist and Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre for Addiction and Mental Health / Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Victor Addiction psychiatrist and scientist, MD, MSc

Role: CONTACT

Victor.Tang@camh.ca

416-535-8501

Andrew MD (c), BHSc, MA (Philosophy)

Role: CONTACT

Facility Contacts

Victor M Addiction psychiatrist and scientist, MD, MSc

Role: primary

Victor.Tang@camh.ca

416-535-8501

Other Identifiers

CTO Project ID: 4520

Identifier Type: -

Identifier Source: org_study_id