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.
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
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
Single group
deep brain stimulation and stereoelectroencephalography
DeviceDeep brain stimulation guided by stereoelectroencephalography
Number of Participants with Treatment-Related Adverse Events
Adverse events associated with SEEG and DBS will be recorded.
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.
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.
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 (%).
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).
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.
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Centre for Addiction and Mental Health
Lead sponsor
University Health Network, Toronto
Collaborator
