FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050737 [Registered on: 15/03/2023] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of 6-month yoga practice on addiction severity in opioid/heroin drug addicts 
Scientific Title of Study   Opioid Use Disorder And Role of Yoga as an Adjunct in Management: Trial of Effectiveness And Mechanisms 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemant Bhargav 
Designation  Assistant Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  NIMHANS Yoga Centre, Department of Integrative Medicine, Near SBI NIMHANS Branch, Hosur Main Road, Near Dairy Circle, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  08026995730  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Bhargav 
Designation  Assistant Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  NIMHANS Yoga Centre, Department of Integrative Medicine, Near SBI NIMHANS Branch, Hosur Main Road, Near Dairy Circle, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  08026995730  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemant Bhargav 
Designation  Assistant Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  NIMHANS Yoga Centre, Department of Integrative Medicine, Near SBI NIMHANS Branch, Hosur Main Road, Near Dairy Circle, NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  08026995730  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Source of Monetary or Material Support  
DBT/Wellcome Trust India Alliance (India Alliance)  
 
Primary Sponsor  
Name  DBT/Wellcome Trust India Alliance (India Alliance)  
Address  Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad - 500034 
Type of Sponsor  Other [It is an independent public charity that funds research in health and biomedical sciences in India.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemant Bhargav  NIMHANS  Room No. G-13, OPD/IPD Block, Department of Integrative Medicine and Room No. 1 OPD/IPD Block, Centre for Addiction Medicine, Department of Psychiatry, NIMHANS, Hosur Road
Bangalore
KARNATAKA 		 08026995730

drbhargav.nimhans@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for Research in Ayush and Integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Care Arm  All subjects in comparator group will be continuing their routine standard care (OST and psycho-social support) till the study concludes. They will be asked to take prescribed medicine and psychosocial support only as prescribed by the psychiatrist.  
Intervention  Yoga along with Assured Standard Treatment Arm  A validated and standardized Yoga program for OUD in addition to their routine standard care (OST + standard psycho-social support). Subjects will be trained in a 45-minute validated yoga module during withdrawal phase and a 60- minute yoga module during maintenance phase by a trained yoga-instructor (MSc-Yogic Science) at the Department of Integrative Medicine, NIMHANS Bengaluru. Total duration of intervention: 24 weeks. First 10 sessions in 2 weeks would be supervised direct in-person sessions; for next 22 weeks patients will be undergoing tele-yoga (online yoga practice 5 sessions/per week). Total dose of yoga: 1 hour per session/ 5 sessions per week for 24 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients meeting only with following criteria will be allowed to undergo the trail.
a) Diagnosis of OUD (Opioid Use Disorder) (DSM – V criteria)
b) Score >3 on Clinical Global Impression – Severity (CGI-S)
c) Age range: 18–50 years
d) All gender
e) Written informed consent
f) Access to smart phone and internet
 
 
ExclusionCriteria 
Details  Patients meeting with following criteria will not be allowed to undergo the trail.
a) Prescription of OST (Opioid Substitution Therapy) other than Buprenorphine/naloxone
b) Severe withdrawal symptoms (COWS>25)
c) Other diseases causing intractable pain
d) Prescription opioids for pain related to other medical conditions
e) Co-morbid alcohol/BZD/Cannabis/Multiple substance dependence in last 6 months except nicotine
f) Impaired intellectual functioning (HMSE<24)
g) MRI contraindications such as claustrophobia, metal implants or paramagnetic objects in the body
h) Neurosurgery/loss of consciousness due to head injury in past/diseases affecting Central Nervous System
i) Severe psychiatric or medical illness preventing practice of yoga program
j) Pregnancy or post-partum
k) Harm-risk to self or others
l) Current/ recent practice of yoga/meditation (>4hr/month in last 3-months) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Abstinence (Negative urine screening for opiates at each follow-up), pain-BPI (Brief Pain Inventory), craving-OCS (Opioid Craving Scale), endorphins, fMRI-BOLD responses in represent to a craving inducing visual cue.  15 days, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of Abstinent Subjects, Maximum Consecutive Days of Abstinence, Self reported frequency of opioid-use, withdrawal symptoms-COWS (The Clinical Opiate Withdrawal Scale), severity-CGI (The Clinical Global Impressions Scale), Pain threshold-algometer, Stress-PSS (Perceived Stress Scale), Sleep-PSQI (The Pittsburgh Sleep Quality Index), Functioning-WSAS (The Work and Social Adjustment Scale), HRV (Heart Rate Variability),
Cortisol, Buprenorphine Dosage and Side-effects(UKU), and Vedic Personality Inventory(VPI) for Gunas. 		 15 days, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   01/04/2023 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The data will be published in peer - reviewed journal after obtaining consent from the subjects. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to [email ID to be provided] drbhargav.nimhans@gmail.com

  6. For how long will this data be available start date provided 30-04-2023 and end date provided 08-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The proposed research aims to test the effects and mechanisms of 6-month Yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study assessing abstinence (opiate negative urine test) at each follow-up, pain, craving, perceived stress, anxiety, quality of sleep, real-world social and work life adjustment and yoga-based mental attitude (gunas). The mechanisms of action of yoga in OUD are proposed to be investigated by assessing- reward circuit activation through fMRI, autonomic functions using Heart rate variability, Plasma Endorphin and Serum Cortisol. The wait-list control group shall continue the standard treatment alone. Hypotheses: Adding Yoga-based intervention to standard treatment will improve abstinence, pain, craving, anxiety, psychological stress, quality of sleep, real-world social and work life functioning and gunas in patients with OUD and there will be demonstrable increase in plasma endorphin levels and reduction in serum cortisol in them. There would also be demonstrable changes in activation of areas of the brain associated with craving in OUD (in response to visual cues related to opioid addiction). Adding yoga in withdrawal phase would reduce withdrawal symptoms and sympathetic arousal ( heart rate variability) with lesser requirement of buprenorphine to manage withdrawal phase than standard treatment alone. 
Close