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CTRI Number  CTRI/2024/07/070067 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How alcohol use progress over the period over period of years 
Scientific Title of Study   Course of Alcohol Use Disorders: A Cross Sectional Hospital Based Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anshul Goyal 
Designation  Junior Resident 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of Psychiatry, Kasturba Medical College, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  8284014272  
Fax    
Email  anshul.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindra Munoli 
Designation  Additional Professor 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of Psychiatry, Kasturba Medical College, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9972028881  
Fax    
Email  ravindra.nm@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ravindra Munoli 
Designation  Additional Professor 
Affiliation  Kasturba Medical College,Manipal 
Address  Department of Psychiatry, Kasturba Medical College, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9972028881  
Fax    
Email  ravindra.nm@manipal.edu  
 
Source of Monetary or Material Support  
Department of Psychiatry, OPD No-33, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, India. Pincode-576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Department of Psychiatry,OPD No.33, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, India.Pincode-576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anshul Goyal  Kasturba Hospital,Manipal  Department of Psychiatry, Kasturba Hospital,Manipal
Udupi
KARNATAKA 		 08284014272

anshul.kmcmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital Institutional Ethics Committee-Student Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F10||Alcohol related disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The patient visiting the Psychiatry Outpatient, Inpatient for treatment and seen in other departments with history of alcohol use disorder/dependance.
Individuals who are able to give consent in English and Kannada .
3)Patient with medical and psychiatric co morbidities.
 
 
ExclusionCriteria 
Details  Patients not consenting to participate for study.
Patients not in a condition to consent for the study due to some condition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 

The course is to be studied in terms of the outcome in terms of maintaining abstinence from alcohol use, continued use of alcohol, lapses, and relapse, throughout the course of alcohol use in a patients lifetime with alcohol dependence using the timeline follow-back method.
This course will be studied cross-sectionally based on the history starting from the first use of alcohol until the cross-section of time at the interview point. 		 cross sectional study 
 
Secondary Outcome  
Outcome  TimePoints 
a) To assess the association between sociodemographic factors such as age, socioeconomic status, family history, occupation, & life stressors & their contributions to the maintenance of dependence patterns, lapses, & relapses through a comprehensive review of individual case files
b) To assess the association of pharmacological & non-pharmacological interventions in sustaining remission, managing lapses, & preventing relapses, to predict treatment outcomes.
c)To assess the correlation between psychiatric & medical comorbidities & their impact on the progression of the illness i.e. does it lead to the continuation of a dependence pattern, helps in maintaining abstinence, or leads to lapses or relapses in the course of lifetime. 		 cross sectional study 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A cross-sectional observational study will be carried out over a period of around 23 months on 126 patients from psychiatry OPD, psychiatry and other wards of Kasturba Hospital. Patients age more than 18 years of age, able to give consent in English or Kannada, with history of alcohol use will be considered. Primary data will be collected by obtaining first-hand information from the respondents themselves regarding the socio-demographic and illness details based on a semi-structured proforma followed by administration of a series of rating scales, over a period of one to two hours to fulfill the aims and objectives of the study. Additional Data will be reviewed from the medical records available in the department.Finally the data will be streamlined and statistical analysis will be carried out to assess, analyse and to determine the course of the illness. No follow-ups are required.
Tools used-
1)Timeline Followback Method
2)Drinking-related locus of control scale (DRIE)
3)Presumptive Stressful Life Events Scale(PSLES)
4)Barratt Impulsiveness Scale 11 (BIS)
5)General Self-Efficacy Scale (GSE)
6)The Perth Alexithymia Questionnaire (PAQ)

The above mentioned self report scales have been translated to Kannada by seeking permission from the author once after IEC approval.

Statistical analysis will be conducted using SPSS version 16. Sociodemographic and clinical characteristics of the sample will be reported using descriptive statistics, including mean, SD, frequency, and percentages.Logistic regression(QL) will be used to assess correlations between establishment of dependance pattern with years of substance consumption.Pearson’s coefficient to compare 2 continuous variables such as quantity of substance consumption with severity of withdrawal symptoms.Paired student T test to compare abstinence/craving before and after intervention.Pearson’s Chi square test to compare presence of substance dependance with presence of family h/o of substance use. Additional Cluster Analysis may be considered as a possibility later after data is collected.

 
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