An interventional study of deep brain stimulation and stereoelectroencephalography in Addiction and Substance Use Disorder (SUD), sponsored by Centre for Addiction and Mental Health. Recruiting at 1 site in Canada. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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.
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.
521 studies on the registry are indexed under Behavior, Addictive; 124 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 399 interventional studies indexed under Behavior, Addictive.
Browse Behavior, Addictive studies →Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.
Compared within Behavior, Addictive, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There will be one arm where everyone will receive DBS
Device: deep brain stimulation and stereoelectroencephalography
Deep brain stimulation guided by stereoelectroencephalography
Also known as: deep brain stimulation, stereoelectroencephalography
Number of Participants with Treatment-Related Adverse Events
Adverse events associated with SEEG and DBS will be recorded.
Time frame: From enrolment to study conclusion at 12 months.
Feasibility Assessed by Recruitment Rates and Protocol Adherence
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.
Time frame: Across 3 years of the anticipated study length.
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.
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
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 (%).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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
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.
Time frame: From enrolment to 12 months.
Plan to share: Undecided — I am not familiar with the process
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