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Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial

Primary Purpose

Alcohol Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Female or Male patients between age 18-70
  2. Diagnosis of alcohol use disorder (AUD) as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
  3. 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).
  4. Alcohol Use Disorders Identification Test (AUDIT) Scale Score >8
  5. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion criteria

  1. Any past or current evidence of psychosis or mania
  2. Current suicidal or homicidal ideation
  3. Active neurologic disease, such as epilepsy
  4. Visible brain damage or atrophy in CT or MRI scan
  5. Any contraindication to MRI or positron emission tomography (PET) scanning
  6. Likely to relocate or move during the study's one year duration
  7. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
  8. Patients with renal dysfunction (GFR<60)
  9. Pregnant or lactating

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep Brain Stimulation Treatment

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (safety and tolerability)
Our primary objective is to establish the safety of deep brain stimulation in a patient population with treatment refractory alcohol use disorder. This is an exploratory pilot study. safety will be reported in the form of adverse event collection, and reported for each patient recruited into the study. Infection, hemorrhage, seizure, sensorymotor disturbance, oculomotor disturbance, or worsening on any adjunctive measure scales used will be reported. These will all be reported on a case-by-case basis, and presented descriptively in the publication. (no specific scale will be used).
Change in Alcohol consumption measured with the alcohol timeline followback
The amount of alcohol consumption preoperatively will be compared with the amount of alcohol consumption postoperatively using the alcohol timeline followback method at 6 months (compared to the preoperative baseline). This will be administered by a psychometrist, and reported as average number of standard drinks consumed daily and weekly during the 6 month postoperative period. An increase from preoperative values is considered a worse outcome, and a decrease in number is an improvement.

Secondary Outcome Measures

Alcohol Dependency Scale
Alcohol Dependency Scale (ADS) will be compared between preoperative baseline and at 6 month follow up.
Alcohol Urge Questionnaire (AUQ)
Alcohol Urge Questionnaire (AUQ) will be compared between preoperative baseline and at 6 month follow up. This scale is scored out of 84, 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.
Alcohol Use Disorder Identification Test (AUDIT)
Alcohol Use Disorder Identification Test (AUDIT) will be compared between preoperative baseline and at 6 month follow up.
Hamilton Depression Scale (HAMD)
Hamilton Depression Scale (HAMD) will be compared between preoperative baseline and at 6 month follow up.
Beck Depression and Anxiety Inventory (BDI and BAI)
Beck Depression and Anxiety Inventory (BDI and BAI) will be compared between preoperative baseline and at 6 month follow up.

Full Information

First Posted
August 7, 2018
Last Updated
September 14, 2020
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03660124
Brief Title
Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
Official Title
Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2018 (Actual)
Primary Completion Date
May 25, 2021 (Anticipated)
Study Completion Date
May 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
DBS is a neurosurgical procedure that involves the administration of small amounts of electricity to disrupt abnormal activity of brain structures associated with disease symptoms. It involves inserting thin electrodes into deep brain structures and electrically stimulating them in a controllable and ultimately reversible manner. The electrodes are connected to an internal pulse generator that is implanted in the upper chest region, below the collarbone.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (safety and tolerability)
Description
Our primary objective is to establish the safety of deep brain stimulation in a patient population with treatment refractory alcohol use disorder. This is an exploratory pilot study. safety will be reported in the form of adverse event collection, and reported for each patient recruited into the study. Infection, hemorrhage, seizure, sensorymotor disturbance, oculomotor disturbance, or worsening on any adjunctive measure scales used will be reported. These will all be reported on a case-by-case basis, and presented descriptively in the publication. (no specific scale will be used).
Time Frame
6 months
Title
Change in Alcohol consumption measured with the alcohol timeline followback
Description
The amount of alcohol consumption preoperatively will be compared with the amount of alcohol consumption postoperatively using the alcohol timeline followback method at 6 months (compared to the preoperative baseline). This will be administered by a psychometrist, and reported as average number of standard drinks consumed daily and weekly during the 6 month postoperative period. An increase from preoperative values is considered a worse outcome, and a decrease in number is an improvement.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alcohol Dependency Scale
Description
Alcohol Dependency Scale (ADS) will be compared between preoperative baseline and at 6 month follow up.
Time Frame
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.
Title
Alcohol Urge Questionnaire (AUQ)
Description
Alcohol Urge Questionnaire (AUQ) will be compared between preoperative baseline and at 6 month follow up. This scale is scored out of 84, 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.
Time Frame
6 months
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
Alcohol Use Disorder Identification Test (AUDIT) will be compared between preoperative baseline and at 6 month follow up.
Time Frame
6 months
Title
Hamilton Depression Scale (HAMD)
Description
Hamilton Depression Scale (HAMD) will be compared between preoperative baseline and at 6 month follow up.
Time Frame
6 months
Title
Beck Depression and Anxiety Inventory (BDI and BAI)
Description
Beck Depression and Anxiety Inventory (BDI and BAI) will be compared between preoperative baseline and at 6 month follow up.
Time Frame
6 months. Both the BDI and BAI are scored out of 63, with higher scores indicating a worse outcome. They will be administered by a psychometrist.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Female or Male patients between age 18-70 Diagnosis of alcohol use disorder (AUD) as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5). 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). Alcohol Use Disorders Identification Test (AUDIT) Scale Score >8 Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols Exclusion criteria Any past or current evidence of psychosis or mania Current suicidal or homicidal ideation Active neurologic disease, such as epilepsy Visible brain damage or atrophy in CT or MRI scan Any contraindication to MRI or positron emission tomography (PET) scanning Likely to relocate or move during the study's one year duration Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure. Patients with renal dysfunction (GFR<60) Pregnant or lactating
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anusha Baskaran, PhD
Phone
416-480-6100
Ext
1650
Email
anusha.baskaran@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Lipsman, MD, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anusha Baskaran, PhD
Phone
416-480-6100
Ext
1650
Email
anusha.baskaran@sunnybrook.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
35858989
Citation
Davidson B, Giacobbe P, George TP, Nestor SM, Rabin JS, Goubran M, Nyman AJ, Baskaran A, Meng Y, Pople CB, Graham SJ, Tam F, Hamani C, Lipsman N. Deep brain stimulation of the nucleus accumbens in the treatment of severe alcohol use disorder: a phase I pilot trial. Mol Psychiatry. 2022 Oct;27(10):3992-4000. doi: 10.1038/s41380-022-01677-6. Epub 2022 Jul 21.
Results Reference
derived

Learn more about this trial

Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial

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