Recruiting

Deep Brain Stimulation

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06973512

Conditions

Addiction

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

deep brain stimulation and stereoelectroencephalography

Study Details

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.

Conditions

Addiction

Substance Use Disorder (SUD)

Study ID

NCT06973512

Start date

Nov 1, 2024

Status verified date

Apr, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

There will be one arm where everyone will receive DBS

Interventions

deep brain stimulation and stereoelectroencephalography

Deep brain stimulation guided by stereoelectroencephalography

Primary outcome measure

  • Number of Participants with Treatment-Related Adverse Events [ Time Frame: From enrolment to study conclusion at 12 months. ]
  • Feasibility Assessed by Recruitment Rates and Protocol Adherence [ Time Frame: Across 3 years of the anticipated study length. ]

Central Contacts and Locations

Central contacts

Victor Addiction psychiatrist and scientist, MD, MSc

416-535-8501Victor.Tang@camh.ca

Locations

Centre for Addiction and Mental Health / Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, 399 Bathurst St

Contacts

Victor M Addiction psychiatrist and scientist, MD, MSc

416-535-8501Victor.Tang@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • addiction
  • substance use disorder
  • deep brain stimulation
  • stereoelectroencephalography
  • biomarker
  • electrophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-04-29.