NCT06973512 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre for Addiction and Mental Health |
| Condition | Addiction |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-11-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06973512 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 65 Years, studying Addiction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06973512 currently recruiting?
Yes, NCT06973512 is actively recruiting participants. Contact the research team at Victor.Tang@camh.ca for enrollment information.
Where is the NCT06973512 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06973512 clinical trial?
NCT06973512 is sponsored by Centre for Addiction and Mental Health. The trial plans to enroll 10 participants.
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