Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660124
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Nir Lipsman, Sunnybrook Health Sciences Centre

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) 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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: Deep Brain Stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : May 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Deep Brain Stimulation Treatment Device: Deep Brain Stimulation
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 Measures :
  1. Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: 6 months ]
    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).

  2. Change in Alcohol consumption measured with the alcohol timeline followback [ Time Frame: 6 months ]
    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 :
  1. Alcohol Dependency Scale [ 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. ]
    Alcohol Dependency Scale (ADS) will be compared between preoperative baseline and at 6 month follow up.

  2. Alcohol Urge Questionnaire (AUQ) [ Time Frame: 6 months ]
    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.

  3. Alcohol Use Disorder Identification Test (AUDIT) [ Time Frame: 6 months ]
    Alcohol Use Disorder Identification Test (AUDIT) will be compared between preoperative baseline and at 6 month follow up.

  4. Hamilton Depression Scale (HAMD) [ Time Frame: 6 months ]
    Hamilton Depression Scale (HAMD) will be compared between preoperative baseline and at 6 month follow up.

  5. Beck Depression and Anxiety Inventory (BDI and BAI) [ 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. ]
    Beck Depression and Anxiety Inventory (BDI and BAI) will be compared between preoperative baseline and at 6 month follow up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660124


Contacts
Layout table for location contacts
Contact: Benjamin Davidson, MD 416-480-6100 ext 1650 benjaminandrewdavidson@gmail.com
Contact: Anusha Baskaran, PhD 416-480-6100 ext 1650 anusha.baskaran@sunnybrook.ca

Locations
Layout table for location information
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Anusha Baskaran, PhD    416-480-6100 ext 1650    anusha.baskaran@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Layout table for investigator information
Principal Investigator: Nir Lipsman, MD, PhD Sunnybrook Health Sciences Centre

Layout table for additonal information
Responsible Party: Dr. Nir Lipsman, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03660124     History of Changes
Other Study ID Numbers: 012-2018
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Alcoholism
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders