| CTRI Number |
CTRI/2025/07/090541 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the Role of Memory and Thinking Abilities in Predicting Relapse in People Recovering from Alcohol Dependence |
|
Scientific Title of Study
|
Cognitive Functioning As Predictor Of Relapse In Subjects With Alcohol Dependence |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankur Singh |
| Designation |
PG Student |
| Affiliation |
SN Medical College Agra |
| Address |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH
282003
India
Agra
UTTAR PRADESH
282003
India |
| Phone |
09929550855 |
| Fax |
|
| Email |
ankursingh1414143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Kumar |
| Designation |
Associate Prof. |
| Affiliation |
SN Medical College Agra |
| Address |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH
282003
India
Agra
UTTAR PRADESH
282003
India |
| Phone |
9837092520 |
| Fax |
|
| Email |
drashutoshkg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Kumar |
| Designation |
Associate Prof. |
| Affiliation |
SN Medical College Agra |
| Address |
Psychiatry Department SN Medical College Agra
Agra
UTTAR PRADESH
282003
India
Agra
UTTAR PRADESH
282003
India |
| Phone |
9837092520 |
| Fax |
|
| Email |
drashutoshkg@gmail.com |
|
|
Source of Monetary or Material Support
|
| SN Medical College, Agra, Uttar Pradesh, India 282003 |
|
|
Primary Sponsor
|
| Name |
SN Medical College |
| Address |
Department of Psychiatry S N Medical College Agra, 282003
|
| 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 Ankur Singh |
SN Medical College, Agra |
2nd floor, Psychiatry Department SN Medical College Agra
UTTAR PRADESH
Agra
UTTAR PRADESH |
09198261931
ankursingh1414143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SN MEDICAL COLLEGE, AGRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All the patients aged between 18-60 years.
2.Patients diagnosed with confirm alcohol dependance according to DSM-5TR(9).
3.Recently initiated alcohol abstinence.
4.Expresses willingness to participate in the study by giving written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients having concurrent dependance on substances other than alcohol and Tobacco.
2. Other severe psychiatric comorbidities.
3. Patient with diagnosed neurological disorder impacting cognitive functioning.
4. Patient with Unstable or severe medical conditions
5. Patient with pre-existing cognitive impairment unrelated to alcohol dependence
6. Patient unable to provide informed consent
7. Pregnant and lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PATIENT RELAPSED OR NOT |
ASSESSMENT OF COGNITION IN 8 WEEK |
|
|
Secondary Outcome
|
|
|
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)
|
06/08/2025 |
| 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
|
This study aims to evaluate the predictive role of cognitive functioning in determining the risk of relapse among individuals with alcohol dependence. Participants will be recruited from the Psychiatry OPD and inpatient services at SNMC, Agra. After informed consent and detoxification, participants will undergo a comprehensive cognitive assessment using the ACE-III (Hindi version), focusing on memory, attention, executive function, visuospatial ability, and language. Participants will be supported in maintaining abstinence and monitored for relapse over 8 weeks. Relapse classification will follow the criteria defined by Feuerlein and Küfner (1989), categorizing outcomes as abstinent, improved, or relapsed. The study will analyze correlations between baseline cognitive performance and relapse risk, aiming to identify cognitive markers that may help predict relapse in early abstinence. |