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Clinical Trials/ISRCTN78042015
ISRCTN78042015
Active, not recruiting
Phase 2

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

Cambridge University Hospitals NHS Foundation Trust0 sites12 target enrollmentAugust 1, 2024
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ConditionsAlcohol and opioid use disorderMental and Behavioural Disorders

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Alcohol and opioid use disorder
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrollment
12
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2024
End Date
January 31, 2026
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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