Baclofen in alcohol dependence; open label, Randomised, study

Not Applicable

• Conditions: Health Condition 1: H- Substance Abuse Treatment

• Registration Number: CTRI/2023/05/052725
• Lead Sponsor: Central Institute Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

Patients diagnosed with mental and behavioural disorder due to use of alcohol dependence syndrome, currently using the substance(F10.24) as per International classification of disease 10th (ICD 10) clinical description and diagnostic guidelines( WHO, 1993) who are ready to give consent and severity of alcohol dependence Questionnaire (SADQ) score > 20 that is moderate to severe alcohol dependence.

Exclusion Criteria

1.Not willing to give consent.2. Age <18 years, >50 years.3.Any other comorbid substance use except nicotine and caffeine.4.Participants having any comorbid psychiatric disorders .Participants having any contraindication for fMRI,6. Patient is receiving any anti craving medication in last 14 days.7. Patients with complicated withdrawal( Delirium Tremens, Seizure)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in craving of alcohol assessed by Alcohol Craving Questionnaire(ACQ-NOW)from baseline to the end of the study. <br/ ><br>2.Change in craving of alcohol assessed by Obsessive Compulsive Drinking Scale (OCDS)from baseline to the end of the study. <br/ ><br>3. Change in withdrawal assessed by CIWA-Ar from baseline to the end of study.Timepoint: Baseline, Day 8, Day 21

Secondary Outcome Measures

Name	Time	Method
1.Change in resting state brain connectivity of Executive Control Network among patients with alcohol dependence from baseline to the end of the study. <br/ ><br>2.Change in cue related functional brain connectivity of Executive Control Network among patients with alcohol dependence from baseline to the end of the study. <br/ ><br>3.Change in Clinical Global Index-Improvement(CGI-I) score from baseline to the end of the study. <br/ ><br>4.Total dosage of Benzodiazepines required to reach CIWA-Ar below 10 <br/ ><br>4.Number of days required to reach CIWA-Ar below 10Timepoint: Baseline, Day 8, Day 21 <br/ ><br>