Effect of transcranial magnetic stimulation on response inhibition and craving in people with alcohol use disorder

Phase 2

• Conditions: Health Condition 1: F102- Alcohol dependence

• Registration Number: CTRI/2023/09/057196
• Lead Sponsor: Dr Jithin T Joseph

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Diagnosis of AUD according to DSM 5. Age 18-60 years, any gender. Person must have the capacity to give informed consent for the study. Right handed individuals ( Handedness will be assessed using Edinburg Handedness Inventory). Patient should have completed detoxification phase and should not be started on anti craving medications (the assements will be done before the initiation of anticraving agent, and it is feasible as the assement will only take 2-3 hours). Patient should not be taking benzodiazepines more than 2mg of lorazepam or equivalent. Patient should not have withdrawal symptoms at the time of recruitment (CIWA ar score less than or equal to 10).

Inclusion Criteria for Healthy Controls: Healthy controls will be screened using modified MINI screen to ensure that they don’t have a diagnosis of major mental illness. Any gender, Age 18-60 years (Age and gender matching will be done for healthy controls according to the patient population). Right handed. Capacity to give written informed consent. HC should be abstinent from alcohol at least a week prior to the assessments.

Exclusion Criteria

Exclusion criteria for patients: Other substance use disorders except nicotine and caffeine use disorder. Other co morbid major mental health diagnosis. (Screening will be done using MINI adult Screen)Delirium tremens/complicated withdrawal A score of 15 or below in SADQ scale (mild AUD).Pregnancy / Post-Partum.Any contra indication for TMS assessments or TMS/tDCS treatment.Co-morbid neurological/medical disease that can affect the brain structure/function.(Recent CVA, Recent MI, any structural brain lesions like tumours, or any CNS infections)

Exclusion criteria for Healthy Controls- Diagnosis of a psychiatric disorder.Family history of psychiatric disorder in any of the first-degree relatives.Current psychoactive substance dependence (except caffeine)Pregnancy / Post-Partum.Any contra indication for TMS assessments (only baseline TMS assessments will be done for healthy controls, and they will not receive single session iTBS) .Co-morbid neurological/medical disease that can affect the brain structure/function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stop Signal Reaction Time (SSRT)Timepoint: baseline & after single session of iTBS.

Secondary Outcome Measures

Name	Time	Method
alcohol cravingTimepoint: baseline & after single session of itbs.