Alcohol Use DisorderNCT03660124
Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
A study testing Deep Brain Stimulation in people with Alcohol Use Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2018to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation Treatment | Experimental | Not described Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (5)
Alcohol Dependency Scale
Alcohol Dependency Scale (ADS) will be compared between preoperative baseline and at 6 month follow up.
Measured: 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 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.
Measured: 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Alcohol Use Disorder Identification Test (AUDIT) will be compared between preoperative baseline and at 6 month follow up.
Measured: 6 months
Hamilton Depression Scale (HAMD)
Hamilton Depression Scale (HAMD) will be compared between preoperative baseline and at 6 month follow up.
Measured: 6 months
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start25 May 2018
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nir Lipsman, Sunnybrook Health Sciences Centre
- Investigators
- Nir Lipsman, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660124
- Sponsor's protocol ID
- 012-2018
- Status last verified
- Dec 2023
- First submitted
- 7 Aug 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35858989
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
- ClinicalTrials.gov ID
- NCT03660124
- Acronym / sponsor ID
- 012-2018
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation Treatment | Experimental | Device: Deep Brain Stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationDBS 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. | Device | Deep Brain Stimulation Treatment |
Primary outcome
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).
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.
5 secondary outcomes
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 Urge Questionnaire (AUQ)
Time frame: 6 months
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: 6 months
Hamilton Depression Scale (HAMD)
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 35858989Davidson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Lipsman, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Alcohol Use Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (safety and tolerability) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03660124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.