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NCT03660124
Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial
NA trial testing Deep Brain Stimulation in Alcohol Use Disorder in 10 participants. Status unknown.
25 December 2024
Quick facts
| Lead sponsor | Sunnybrook Health Sciences Centre |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 25 May 2018 |
| Primary completion | 25 December 2024 |
| Estimated completion | 25 December 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Deep Brain Stimulation
Conditions studied
- Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
Sponsor
Sunnybrook Health Sciences Centre — full company profile →
Who can join
Adults 18 to 70, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Deep brain stimulation of the nucleus accumbens in the treatment of severe alcohol use disorder: a phase I pilot trial.
Davidson B, Giacobbe P, George TP, Nestor SM, et al · · 2022 · cited 37× · PMID 35858989 · DOI 10.1038/s41380-022-01677-6 -
Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991 -
Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.
Tremblay-McGaw AG, Hamlat EJ, Becker NC, Astudillo Maya DA, et al · · 2025 · cited 1× · PMID 40309667 · DOI 10.3389/fnhum.2025.1572972
Verify or expand the search:
- PubMed search for NCT03660124
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03660124 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sunnybrook Health Sciences Centre
- Last refreshed: 5 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03660124.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing