| CTRI Number |
CTRI/2026/02/103282 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of social and family support in the patient suffering from opioid and alcohol use in preventing there relapse and in the establishment of the healthy substance free life |
|
Scientific Title of Study
|
Association of perceived social support on the quality of life and clinical profile among patients suffering from opioid use disorder and alcohol use disorder respectively |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRSANJIBANI PANIGRAHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
shri mahant indiresh hospital |
| Address |
Department of psychiatry shri mahant indiresh hospital, patelnagar Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9033543780 |
| Fax |
|
| Email |
Sanjibanipanigrahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSANJIBANI PANIGRAHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
shri mahant indiresh hospital |
| Address |
Department of psychiatry shri mahant indiresh hospital patelnagar Dehradun Uttarakhand
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9033543780 |
| Fax |
|
| Email |
Sanjibanipanigrahi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR.VIVEK PANT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
shri mahant indiresh hospital |
| Address |
Department of psychiatry
shri mahant indiresh hospital patelnagar Dehradun Uttarakhan
Almora
UTTARANCHAL
248001
India |
| Phone |
9557734969 |
| Fax |
|
| Email |
vivekpant_000@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Shri guru ram rai institute of medical and health sciences |
|
|
Primary Sponsor
|
| Name |
Shri guru ram rai institute of medical and health sciences |
| Address |
Patel nagar,dehradun,uttarakhand
248001 |
| Type of Sponsor |
Private 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 |
| archna tiwari |
SHRI MAHANT INDIRESH HOSPITAL |
Department of psychiatry,shri mahant indiresh hospital patelnagar dehradun uttarakhand
Dehradun
UTTARANCHAL |
8076602576
anamikatiwari004@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SHRIGURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES PATELNAGAR DEHRADUN 248001 |
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 |
| Comparator Agent |
Nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
patient with diagnosis of opiate alcohol and cannabis use disorder based on criteria of diagnostic and statistical manual of mental disorder DSM 5
patient age 118-59 years
patient giving written consent to participate in protocol
both male and female |
|
| ExclusionCriteria |
| Details |
polysubstance use
severe cognitive impairment or intellectual disability
serious medical condition such as terminal illness major organ failure
currently intoxicated or experiencing severe withdrawal symptoms at the time of assessment(to ensure valid response |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the impact of perceived social support in patient of opioid use disorder and its outcome in preventing relapse and its correlation with variables |
to assess the impact of perceived social support in patient of opioid use disorder and its outcome in preventing relapse and its correlation with variables |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
02/03/2026 |
| 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="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
|
this study aims to examine the relationship between percieved social support and quality of life among the patients with opioid use disorder and alcohol use disorder. substance use disorders are frequently associated with impaired functioning ,psychiatric comorbidity, and reduced socialsupport all of which affect recovery and overall well being .percieved social support has been shown to influence coping, relapse risk ,and treatment outcomes ,but limited indian data compare this relationship across specific substance use groups .this cross sectional study will recruit clinically stable adults(18-59) diagnosed with OUD and AUD after informed consent .sociodemographic and clinical details will be recorded, followed by administration of standardised instrument using includes MSPSS,HOQOL-BREF,BECK DEPRESSION INVENTORY,BECKS ANXIETY INVENTORY,AND ADDICTION PROFILE INDEX
the primary objective are to assess the association between social support and quality of life within each group to compare outcomes between OUD and AUD while adusting for depression ,anxiety, and addiction severity. data will be analysed using appropriate descriptive statistics t-test or non parametric test, correlation and multivariable regression models,. the findings may help identify psychosocial factors relevent for clinical intervention and rehabilitation planning in substance use disorder |