| 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
|
|
|
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. |