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Device

Deep Brain Stimulation for Alcoholism

N/A
Waitlist Available
Led By Nir Lipsman, MD, PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female or Male patients between age 18-70
History of AUD for at least 2 years, with evidence of repeated failure to respond to evidence-based AUD treatments (psychosocial treatments plus pharmacotherapies such as disulfiram, naltrexone and acamprosate).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months. this scale is scored out of 47, and will be administered by a psychometrist preoperatively and at 6 months postoperatively. higher scores are considered worse, so a decrease from baseline is an improvement.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if brain stimulation can help treat Alcohol Use Disorder in people who have not responded to other treatments. It will measure the safety and effectiveness of the treatment.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects are not listed here, DBS can generally cause headaches, seizure, infection at the implantation site, speech problems or mood changes. The primary goal of this phase I trial is to assess these potential risks in patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
I have struggled with alcohol use for over 2 years and treatments haven't worked.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months. this scale is scored out of 47, and will be administered by a psychometrist preoperatively and at 6 months postoperatively. higher scores are considered worse, so a decrease from baseline is an improvement.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months. this scale is scored out of 47, and will be administered by a psychometrist preoperatively and at 6 months postoperatively. higher scores are considered worse, so a decrease from baseline is an improvement. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Alcohol consumption measured with the alcohol timeline followback
Incidence of treatment-emergent adverse events (safety and tolerability)
Secondary study objectives
Alcohol Dependency Scale
Alcohol Urge Questionnaire (AUQ)
Alcohol Use Disorder Identification Test (AUDIT)
+2 more

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948
23%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Dyspepsia
5%
Back pain
5%
Skeletal injury
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Osteoarthritis
3%
Ingrowing nail
3%
Postoperative wound infection
3%
Diabetes mellitus
3%
Pain in extremity
3%
Spinal osteoarthritis
3%
Alcohol poisoning
3%
Intervertebral disc protrusion
3%
Hypoaesthesia
3%
Diplopia
3%
Contusion
3%
Productive cough
3%
Joint sprain
3%
Macular degeneration
3%
Fluid retention
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation TreatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,845 Total Patients Enrolled
Nir Lipsman, MD, PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
3 Previous Clinical Trials
24 Total Patients Enrolled
~0 spots leftby Dec 2024
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