Status:
COMPLETED
A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear
Lead Sponsor:
DyAnsys, Inc.
Conditions:
Alcohol Use Disorder
Eligibility:
MALE
18-50 years
Phase:
NA
Brief Summary
Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with ...
Detailed Description
Patients will be recruited into the study after obtaining informed consent. The intervention will be started after completion of detoxification, which will be done with Lorazepam using a front-loading...
Eligibility Criteria
Inclusion
- Diagnosis of Alcohol use disorder (AUD) as per DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two psychiatrists working in the department of psychiatry NIMHANS.
- Male gender.
- Age not less than 18 years and not more than 50 years.
- At least, moderately severe AUD as ascertained by a score above 16 in Severity of Alcohol dependence questionnaire (SADQ).
- Right-handedness as assessed with Edinburgh Handedness Inventory.
- Informed consent and willingness to come for regular follow-ups (once every two weeks) for three months after recruitment in the study.
Exclusion
- Any diagnosis except alcohol dependence syndrome/ Tobacco dependence syndrome (to apply MINI(Mini International Neuropsychiatric Interview) screen).
- Contra-indications precluding device use-
- 1 patient with cardiac implants or similar biomedical implants, 2.2 during pregnancy unless medically advised, 2.3 patient with haemophilia 2.4 skin pathology 2.5 patient with diminished mental capability or physical competence about the handling of the device
- Left/ mixed handedness
- Contraindications to MRI
Key Trial Info
Start Date :
October 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04106739
Start Date
October 20 2019
End Date
December 27 2021
Last Update
March 3 2022
Active Locations (1)
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1
National Institute of Mental Health and Neuro sciences(NIMHANS)
Bengaluru, Karnataka, India, 560029