Deep Brain Stimulation for Alcoholism

Recruiting in Palo Alto (17 mi)

Overseen byNir Lipsman, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of DBS for AUD. Patients who meet inclusion and exclusion criteria will be identified and recruited from the practices of Sunnybrook psychiatrists. Five (5) to ten (10) subjects will be enrolled and study duration for each patient will be of one (1) year. Our primary objective is to establish the safety of DBS in a patient population with treatment refractory AUD. In addition to demonstrating safety, our second primary objective will be to evaluate if DBS-targeted nucleus accumbens in alcoholism is efficacious in the treatment-refractory patients with AUD. This will be measured by various outcome measures that will include validated scales to assess addiction and craving behaviours.

Research Team

Nir Lipsman, MD, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for adults aged 18-70 with a history of Alcohol Use Disorder (AUD) for at least two years, who haven't improved after trying standard treatments and medications. Participants must be able to consent to the study and attend all required sessions. They should score more than 8 on the AUDIT scale, which measures alcohol consumption behaviors.

Inclusion Criteria

I am between 18 and 70 years old.

I have struggled with alcohol use for over 2 years and treatments haven't worked.

You understand the study and can follow all the rules and appointments.

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Treatment Details

Interventions

Deep Brain Stimulation (Device)

Trial OverviewThe trial tests Deep Brain Stimulation (DBS) safety and effectiveness in treating people whose AUD hasn't gotten better with usual care. Five to ten patients will have DBS targeting a brain area linked to addiction, monitored over one year using scales that measure addiction and craving.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Deep Brain Stimulation TreatmentExperimental Treatment1 Intervention

Deep Brain Stimulation is already approved in Canada for the following indications: