10 Participants Needed

Deep Brain Stimulation for Addiction

(HABITS Trial)

VA
Overseen ByVictor Addiction psychiatrist and scientist, MD, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre for Addiction and Mental Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

The HABITS Study is for individuals with severe substance use disorders who have not successfully quit using harmful substances despite trying other treatments. Participants will undergo detoxification and must be willing to stay at a hospital for 1-2 weeks, followed by a year of psychiatric care.

Inclusion Criteria

Severe DSM-5 substance use disorder (SUD) as assessed by Structured Clinical Interview for DSM-5 (SCID-5)
I am between 25 and 65 years old.
Able to comply with study visit schedule and timeline
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Exclusion Criteria

Cardiac pacemaker/defibrillator, or other implanted stimulator
Serious problems with literacy, vision, or hearing
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
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Detoxification

Participants undergo detoxification with CAMH

1-2 weeks
Inpatient stay at CAMH

Treatment

Participants receive deep brain stimulation (DBS) guided by stereoelectroencephalography (SEEG) at Toronto Western Hospital

1-2 weeks
Inpatient stay at Toronto Western Hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment, receiving standard psychiatric care

12 months
11 study visits

Treatment Details

Interventions

  • Deep Brain Stimulation Guided By Stereoelectroencephalography
Trial Overview This pilot trial tests deep brain stimulation (DBS) guided by stereoelectroencephalography (SEEG) in treating addiction. DBS uses electrical impulses to stimulate the brain, while SEEG helps personalize treatment by mapping areas related to addiction.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
There will be one arm where everyone will receive DBS

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+
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