AddictionHABITSNCT06973512
HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders
A study testing deep brain stimulation and stereoelectroencephalography in people with Addiction and Substance Use Disorder (SUD), run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Addiction, Substance Use Disorder (SUD)
- What is being tested?
- deep brain stimulation and stereoelectroencephalography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health / Toronto Western Hospital
Toronto, Ontario, 399 Bathurst St
Victor M Addiction psychiatrist and scientist, MD, MSc, 416-535-8501, Victor.Tang@camh.ca
About this study
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.
Read more
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.
Read the 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)
- Being tested
- deep brain stimulation and stereoelectroencephalography
- Keywords
- addiction, substance use disorder, deep brain stimulation, stereoelectroencephalography, biomarker, electrophysiology
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulation and stereoelectroencephalographyDevice
Also called deep brain stimulation, stereoelectroencephalography
Deep brain stimulation guided by stereoelectroencephalography
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | There will be one arm where everyone will receive DBS Receives: Device: deep brain stimulation and stereoelectroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events
Adverse events associated with SEEG and DBS will be recorded.
Measured: From enrolment to study conclusion at 12 months.
Feasibility Assessed by Recruitment Rates and Protocol Adherence
Feasibility will be evaluated through the following metrics:
- Recruitment Rates: yearly and total number of participants recruited.
- Protocol Adherence: percentage of completed study visits.
Measured: Across 3 years of the anticipated study length.
Secondary outcomes (6)
Proportion of Negative Urine Toxicology for Primary Substance (%) Assed by Urinalysis
Supervised urine specimens are collected and screened with a point-of-care immunoassay, followed by GC-MS confirmation. Negative is defined as analyte concentration below the laboratory cut-off for the participant's primary substance of use (e.g., < 300 ng/mL benzoylecgonine for cocaine). This outcome is the percentage of participants whose sample is negative at the Month 12 endpoint.
Measured: From enrolment to study conclusion at 12 months.
Change From Baseline in Days of Primary Substance Use Assessed by Timeline Follow-Back Self-Report
Timeline Follow-Back (TLFB) is a validated calendar interview conducted by trained staff. At enrollment, participants report their substance use for the past 90 days, and then, post-intervention, they report the number of days they used their primary substance between each study visit until study conclusion at 12 months. The proportion of days of substance use compared to not using during the 90 days before enrolment is compared to the proportion of days used versus not post-operatively, where the metric is in percentage (%).
Measured: From enrolment to study conclusion at 12 months.
Self-Reported Substance Craving Assessed Using a 0-10 Visual Analog Scale
Craving is assessed with a 0-10 Visual Analog Substance Craving Scale administered by trained research staff. Participants mark their current urge to use on RedCAP, where 0 = "no craving at all" and 10 = "strongest craving imaginable." This outcome is the change in score from baseline (Week 0) to the Month 12 endpoint (Week 52 ± 2 weeks). Scores range 0-10; lower values indicate reduced craving (better outcome).
Measured: From enrolment to study conclusion at 12 months.
Depressive Symptom Severity Assessed by Patient Health Questionnaire (PHQ-9)
The 9-item Patient Health Questionnaire (PHQ-9) is a self-administered scale that rates the frequency of depressive symptoms over the past two weeks on a 4-point scale (0 = "Not at all" to 3 = "Nearly every day"). Total scores range 0-27; higher scores indicate more severe depression (cut-offs: 5 = mild, 10 = moderate, 15 = moderately severe, 20 = severe). The outcome is change in total score from baseline (Week 0) to the Month 12 endpoint (Week 52 ± 2 weeks). Negative values reflect clinical improvement.
Measured: From enrolment to study conclusion at 12 months.
Anxiety Symptom Severity Asssed by General Anxiety Disorder (GAD-7)
The 7-item Generalized Anxiety Disorder Scale (GAD-7) is a self-administered questionnaire that rates the frequency of anxiety symptoms over the past two weeks on a 4-point scale (0 = "Not at all" to 3 = "Nearly every day"). Total scores range 0-21; higher scores indicate more severe anxiety (cut-offs: 5 = mild, 10 = moderate, 15 = severe). This outcome is the change in total score from baseline (Week 0) to the Month 12 endpoint (Week 52 ± 2 weeks). Negative values reflect clinical improvement.
Measured: From enrolment to study conclusion at 12 months.
Electrophysiology Activity Correlating with Craving Assed by Brain Recordings Using Deep Brain Stimulation Electrodes and Stereoelectroencephalography
Stereoelectroencephalography and deep brain stimulation electrodes will be used to record electrophysiological signals from the brain, also known as local field potentials (LFP), during low and high craving periods post-operatively, to the end of the study. The electrophysiology correlate of craving will be assessed by selecting the LFP spectral feature that best discriminates high- vs low-craving states, which will be assessed by the feature with the highest area under the ROC curve (AUC) of a logistic-regression model.
Measured: From enrolment to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Nov 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Victor Tang, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973512
- Sponsor's protocol ID
- CTO Project ID: 4520
- Acronym
- HABITS
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: I am not familiar with the process
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06973512
- Acronym / sponsor ID
- HABITS / CTO Project ID: 4520
- Conditions
- Addiction, Substance Use Disorder (SUD)
- Keywords
- addiction, substance use disorder, deep brain stimulation, stereoelectroencephalography, biomarker, electrophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: deep brain stimulation and stereoelectroencephalographyThere will be one arm where everyone will receive DBS |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulation and stereoelectroencephalographyAlso: deep brain stimulation, stereoelectroencephalographyDeep brain stimulation guided by stereoelectroencephalography | Device | Treatment |
Primary outcome
Number of Participants with Treatment-Related Adverse Events
Time frame: From enrolment to study conclusion at 12 months.
Adverse events associated with SEEG and DBS will be recorded.
Feasibility Assessed by Recruitment Rates and Protocol Adherence
Time frame: Across 3 years of the anticipated study length.
Feasibility will be evaluated through the following metrics: 1. Recruitment Rates: yearly and total number of participants recruited. 2. Protocol Adherence: percentage of completed study visits.
6 secondary outcomes
Proportion of Negative Urine Toxicology for Primary Substance (%) Assed by Urinalysis
Time frame: From enrolment to study conclusion at 12 months.
Change From Baseline in Days of Primary Substance Use Assessed by Timeline Follow-Back Self-Report
Time frame: From enrolment to study conclusion at 12 months.
Self-Reported Substance Craving Assessed Using a 0-10 Visual Analog Scale
Time frame: From enrolment to study conclusion at 12 months.
Depressive Symptom Severity Assessed by Patient Health Questionnaire (PHQ-9)
Time frame: From enrolment to study conclusion at 12 months.
Anxiety Symptom Severity Asssed by General Anxiety Disorder (GAD-7)
Time frame: From enrolment to study conclusion at 12 months.
Electrophysiology Activity Correlating with Craving Assed by Brain Recordings Using Deep Brain Stimulation Electrodes and Stereoelectroencephalography
Time frame: From enrolment to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. I am not familiar with the process
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation and stereoelectroencephalography in people with Addiction and Substance Use Disorder (SUD), run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Addiction psychiatrist and scientist, MD, MSc (416-535-8501, Victor.Tang@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events (time frame: From enrolment to study conclusion at 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.