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CTRI Number  CTRI/2024/02/062315 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 30/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To study effect of drug addiction on memory and intelligence  
Scientific Title of Study   To study defined domains of cognitive functioning using computer based assessment system in patients of opioid dependence disorder  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrinmai Krishna Pevekar 
Designation  Senior Resident  
Affiliation  Punjab Institute of Medical Sciences, Jalandhar 
Address  Punjab Institute of Medical Sciences Room no.4021 Department of Psychiatry OPD no.5 Garha road Jalandhar Punjab

Jalandhar
PUNJAB
144006
India 
Phone  8850644386  
Fax    
Email  mrinmaipevekar@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Himanshu Sareen 
Designation  Professor 
Affiliation  Punjab Institute of Medical Sciences 
Address  Punjab Institute of Medical Sciences Department of Psychiatry Garha Road Jalandhar

Jalandhar
PUNJAB
144006
India 
Phone  9478022117  
Fax    
Email  himanshu.sareen@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Himanshu Sareen 
Designation  Professor 
Affiliation  Punjab Institute of Medical Sciences 
Address  Punjab Institute of Medical Sciences Department of Psychiatry Garha Road Jalandhar

Jalandhar
PUNJAB
144006
India 
Phone  9478022117  
Fax    
Email  himanshu.sareen@gmail.com  
 
Source of Monetary or Material Support  
Punjab Institute of Medical Sciences Garha Road Jalandhar Punjab 144006 
 
Primary Sponsor  
Name  Mrinmai Pevekar  
Address  Punjab Institute of Medical Sciences, Garha Road Jalandhar 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
Himanshu Sareen   Punjab Institute of Medical Sciences, Jalandhar 
Punjab Institute of medical Sciences Jalandhar  Garha Road, Jalandhar, Punjab 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mrinmai   Punjab Institute of Medical Sciences   Department of Psychiatry Garha road Jalandhar
Jalandhar
PUNJAB 
8850644386

mrinmaipevekar@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Punjab Institute ofMedical Sciences Garba Road,Jalandhar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Observational  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Diagnosed with Opioid dependence according to ICD-10 
 
ExclusionCriteria 
Details  1. Those having any psychiatric comorbidities ( except substance use disorder )
2. Those currently in withdrawal.
3. Those having below average intelligence
4. Those medical illness with likely central nervous system manifestation ( e.g Stroke, SLE, Porphyrias)
5. History of significant head injury.
6. Those having physical ailments which would render it difficult or impossible to perform tests e.g. blindness, hearing impairment .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess defined cognitive domains in patients of Opioid dependence disorder  At baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
To find association between socio-demographic variables & patterns of Opioid dependence disorder with various domains of Cognition .

 
At baseline

 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/02/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Participants will be recruited for the study based on inclusion and exclusion criteria. Patients will be taken from in-patient de-addiction ward and out patient  department from Department of Psychiatry, Punjab institute of Medical Science , Jalandhar. Participants will be verbally interviewed, in which the investigator will obtain a brief socio-demographic detail of the participants, followed by  detailed history of opioid and other substance use will be obtained including the current treatment details. Criteria of Opioid use disorder will be applied based on ICD-10 (International Classification of Diseases), those fulfilling the criteria will be selected for study. Participants included in the study will be then evaluated for psychiatric morbidities as it is one of the exclusion criteria using the SCAN (Schedule for clinical Assessment in Neuropsychiatry ), this will be applied by the investigator. They will be undergoing IQ assessment done by Clinical Psychologist using Ravens Progressive Matrices. Participants scoring below 90 will be excluded from the study.

Participants current stage in Opioid use disorder will be assessed with help of Clinical Opioid withdrawal scale (COWS) by the investigator.  Those scoring less than 5 will be included in the study.

Then the self-administered computer based testing of cognition will be done  using CANTAB , where the participant will be supervised by the investigator in case they have difficulty in conducting the test. Following this the scores obtained on the scales will be noted using Microsoft excel sheet and will be statistically  analyzed. Comparison based on socio-demographic and clinical parameters like dose of opioid use, duration of Opioid use will be done and results will be analyzed using appropriate statistical tests.

 
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