| CTRI Number |
CTRI/2026/04/108406 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using Virtual Reality and Simple Computer Tasks To Understand Recovery in People Struggling with Alcohol Use. |
|
Scientific Title of Study
|
Evaluating the Association of Addictions Neuroclinical Assessments based Measures with
Treatment Outcomes and their Change following Virtual Reality Cue Exposure In Individuals
with Alcohol Use Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Ananya Mishra |
| Designation |
PhD Scholar, Dept of Psychiatry, AIIMS Bhopal |
| Affiliation |
AIIMS Bhopal |
| Address |
AIIMS Campus Rd, Saket Nagar, Habib Ganj Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575057740 |
| Fax |
|
| Email |
ananya0503@icloud.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Vijender Singh |
| Designation |
Professor, Head of Dept of Psychiatry, AIIMS Bhopal |
| Affiliation |
AIIMS Bhopal |
| Address |
AIIMS Campus Rd, Saket Nagar, Habib Ganj Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9810930723 |
| Fax |
|
| Email |
vijender.psy@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Ananya Mishra |
| Designation |
PhD Scholar, Dept of Psychiatry, AIIMS Bhopal |
| Affiliation |
AIIMS Bhopal |
| Address |
AIIMS Campus Rd, Saket Nagar, Habib Ganj Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575057740 |
| Fax |
|
| Email |
ananya0503@icloud.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, AIIMS Campus Road, Saket Nagar, Habib Ganj, Bhopal, Madhya Pradesh, Pin Code: 462020 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
AIIMS Campus Rd, Saket Nagar, Habib Gang, Bhopal, Madhya Pradesh, PIN code: 462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijender Singh |
All India Institute of Medical Sciences |
Psychiatry Department, AIIMS Campus, Saket Nagar, Habib Ganj, Pin Code: 462020
Bhopal
MADHYA PRADESH |
9810930723
vijender.psy@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee-Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TAU arm |
This arm will be given Treatment as usual care of AUD patients in psychiatry ward (standard medicines and psychotherapy) |
| Intervention |
Virtual Reality Cue Exposure (VRCE) |
Multiple sessions of VRCE will be administered to experiment group where they will be exposed to alcohol related cues such as rooms with alcohol bottles present. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Diagnosis of Alcohol Use Disorder (AUD) as per DSM-5 criteria, Currently admitted to the inpatient psychiatry unit at AIIMS Bhopal, Able to understand instructions and perform computerized tasks in Hindi or English, None or mild alcohol withdrawal at the time of assessment Willing and able to provide written informed consent, Willing and eligible for disulfiram as a pharmacological treatment at the time of discharge. |
|
| ExclusionCriteria |
| Details |
1. Comorbid psychiatric disorders (e.g., schizophrenia, bipolar disorder) or other
substance use disorders, excluding nicotine
2. Comorbid neurological conditions that interfere with computerized assessment or
VR use (e.g., epilepsy, traumatic brain injury, seizure disorders)
3. Severe cognitive impairment (as determined by clinical judgment or documented
history) that prevents meaningful task engagement
4. Visual or motor impairments that limit the ability to interact with computerized
or VR-based tasks
5. Current use of medications or medical conditions that may significantly affect
cognitive functioning (e.g., delirium, heavy sedation)
6. Current use of medications or medical conditions that can affect craving (e.g.,
Naltrexone, Baclofen etc. )
7. History of severe motion sickness/vertigo, severe migraine triggered by visual
stimuli |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary treatment outcome that will be measured is Craving via the Penn Alcohol Craving Scale (PACS). |
4-week follow-up post discharge (+/- 1 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pattern of Alcohol Consumption, coping, readiness etc via TLFB, RCQ, semi structured proforma, Brief Cope Scale etc |
same as primary outcome, i.e. 4 week post discharge |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/09/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective pretest-post test control group design to examine the association of Addictions Neuroclinical Assessment (ANA) based measures with treatment outcomes in Alcohol Use Disorder (AUD) after a Virtual Reality Cue Exposure (VRCE) intervention. Fifty inpatients with AUD admitted to the Psychiatry Ward at AIIMS Bhopal will be recruited using purposive sampling and randomly allocated to either a Virtual Reality Cue Exposure (VRCE) + Treatment as usual (TAU) control group. After stabilization patients will complete baseline behavioural tasks and self report measures. VRCE intervention will be given to experiment group and TAU to control group. Follow up measures will be conducted 4 weeks post discharge. Change in results of ANA measures will be compared pre and post intervention as well as its effect on treatment outcomes. |