Deep brain stimulation for addictio

Phase 2

• Conditions: Alcohol and opioid use disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN78042015
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Last Update Posted: 12 August 2024
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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