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Deep brain stimulation for addiction

Deep brain stimulation for disorders of addiction: mechanisms and a pilot blinded randomized cross-over placebo-controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78042015
Enrollment
12
Registered
2024-08-01
Start date
2023-08-31
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol and opioid use disorder Mental and Behavioural Disorders

Interventions

Following neurosurgical implantation, deep brain stimulation (DBS) will be delivered at chronic high frequency (~130 hz
2-4 V) in the nucleus accumbens and ventral internal capsule. The stimulation protocol parameters will be optimized over the 6-month open-label stimulation optimization period. At postoperative month

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
University of Cambridge
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of treatment-refractory opioid use disorder (OUD) or alcohol use disorder (AUD) (DSM-5 diagnosis) 2. Comorbid nicotine dependence, other psychoactive use disorder permissible as long as OUD or AUD is the primary diagnosis 3. At least 5 years duration 4. 3+ failed abstinence attempts 5. Failed psychotherapy and standard pharmacotherapy 6. Age 18 to 60 years old 7. MRI compatible 8. Capable of informed consent

Exclusion criteria

Exclusion criteria: 1. Deep brain stimulation or neurosurgical contraindication (e.g. unable to tolerate general anaesthesia, risk of bleeding) 2. History of repeated falls 3. Other major psychiatric (e.g. schizophrenia, bipolar disorder or severe major depression) or neurologic disorder 4. Major head injury 5. Marked cognitive impairment or cortical atrophy

Design outcomes

Primary

MeasureTime frame
Alcohol and opioid use is measured using Timeline Followback during randomised control cross-over trial at baseline and months 1, 2, 3 and 4

Secondary

MeasureTime frame
Alcohol and opioid use is measured using Timeline Followback during open-label stimulation optimisation at baseline and months 1, 2, 3, 4, 5, 6

Countries

England, United Kingdom

Contacts

Public ContactValerie;Samantha Voon;Sallie

;

vv247@cam.ac.uk;sns36@cam.ac.uk+44 (0)1223 761 327;+44 (0)1223761327

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 30, 2026