| CTRI Number |
CTRI/2024/05/068219 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Estimating frequency of depressive and anxiety symptoms in patients dependent on use of alcohol versus opioid |
|
Scientific Title of Study
|
Prevalence of depressive and anxiety symptoms in patients of alcohol versus opioid dependence |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ribhav Gupta |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Psychiatry, Level-5, D Block
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9501987657 |
| Fax |
|
| Email |
ribhavgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Psychiatry, Level-5, D Block
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Sidana |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Psychiatry, Level-5, D Block
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9056422679 |
| Fax |
0172-2609360 |
| Email |
ajeetsidana@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector-32, Chandigarh, India. Pin code: 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Government Medical College and Hospital, Sector 32, Chandigarh, India. Pin Code: 160030 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ribhav Gupta |
Government Medical College and Hospital |
Room No. 4212, Psychiatry OPD, Level 4, B-Block, Government Medical College and Hospital, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH |
9501987657
ribhavgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College and Hospital, Sector 32, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Not applicable |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Patients fulfilling the criteria for Alcohol Dependence or Opioid Dependence diagnosed as per ICD-11 |
|
| ExclusionCriteria |
| Details |
1.Patients with diagnosis of Organic Brain Syndrome or Intellectual Disability.
2.Patient fulfilling the criteria for both Alcohol Dependence and Opioid Dependence diagnosed as per ICD-11.
3.Patient in Moderate or Severe Alcohol Withdrawal (CIWA-Ar Score of greater than or equal to 10).
4.Patient in Moderate or Severe Opioid Withdrawal (COWS Score of greater than or equal to 13).
5.Patient in substance intoxication during presentation or interview.
6.Patient of any other substance dependence, other than nicotine or caffeine.
7.Patient on any psychotropic medication for depression or anxiety since last 2 weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of depressive and anxiety symptoms in patients of alcohol versus opioid dependence |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment & comparison of the severity of depressive & anxiety symptoms with severity of alcohol versus opioid dependence |
Baseline |
| Socio-demographic & clinical correlates of severity of alcohol versus opioid dependence, & comorbid depressive & anxiety symptoms |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
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)
|
15/06/2024 |
| 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="6"
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
|
Patients fulfilling the criteria for Alcohol
Dependence or Opioid Dependence diagnosed as per ICD-11 will be approached for
participation in the study. Two hundred and eighty-eight (288) patients meeting
the inclusion and exclusion criteria will be enrolled in the study after
obtaining informed written consent. The socio demographic and clinical details
shall be recorded on the semi-structured proforma prepared for the study. One
hundred and forty-four (144) patients diagnosed as alcohol dependence as per
ICD-11 shall be subjected to clinical scales namely Severity of Alcohol
Dependence Questionnaire (SADQ-C), Hamilton Depression Rating Scale (HDRS) and
Hamilton Anxiety Rating Scale (HAM-A). One hundred and forty-four (144) patients
diagnosed as opioid dependence as per ICD-11 shall be subjected to clinical
scales namely Severity of Opiate Dependence Questionnaire (SODQ), Hamilton
Depression Rating Scale (HDRS) and Hamilton Anxiety Rating Scale (HAM-A). After
assessment of these symptoms, the same will be communicated to the treating
psychiatrist to aid in the subsequent clinical management of the patient. If at
any point, any patient withdraws the consent, he/she will be considered dropped
out of the study. |