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CTRI Number  CTRI/2025/07/090712 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see the effect of yoga on impulsive behavior and thinking in people with opioid addiction. 
Scientific Title of Study   Effect of a validated yoga intervention on cognitive functions in patients with opioid use disorder - a randomized controlled study. 
Trial Acronym  YOCINOUD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suddala Goutham 
Designation  PhD Student 
Affiliation  National Institute of Mental Health and Neuroscience. 
Address  New Yoga Centre Building, 2nd floor, Room no.2, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India. Bangalore KARNATAKA 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  8332924301  
Fax    
Email  gouthamreddy148@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Bhargav 
Designation  Associate Professor of Yoga 
Affiliation  National Institute of Mental Health and Neuroscience. 
Address  First floor, Room no.3, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India. Bangalore, Karnataka 560029, India. Bangalore KARNATAKA 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  8762019348  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharath Holla 
Designation  Associate Professor of Psychiatry 
Affiliation  National Institute of Mental Health and Neuroscience. 
Address  First floor, Room no.3, Department of Integrative Medicine, NIMHANS, Bangalore, Karnataka, India. Bangalore, Karnataka 560029, India. Bangalore KARNATAKA 560029 India

Bangalore
KARNATAKA
560029
India 
Phone  9844259459  
Fax    
Email  hollabharath@gmail.com  
 
Source of Monetary or Material Support  
Department of Integrative Medicine, NIMHANS and DBT/Wellcome Trust India Alliance Fellowship [grant number IA/CPHE/21/1/505978] awarded to Dr. Hemant Bhargav. 
 
Primary Sponsor  
Name  Department of Integrative Medicine NIMHANS 
Address  NIMHANS, Bangalore, Karnataka, India. Bangalore, Karnataka 560029, India. Bangalore KARNATAKA 560029 India 
Type of Sponsor  Research institution and hospital 
 
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 Suddala Goutham  NIMHANS  CENTRE FOR ADDICTION MEDICINE, In-patient ward, NIMHANS, Bangalore, Karnataka 560029, India. Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8332924301

gouthamreddy148@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for 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  Treatment as usual and Interactive Health Education with stretching exercises  The control group will continue to take the medication prescribed by the treating Psychiatrist. Instead of Yoga intervention they would be given Interactive health education and stretching exercises for a period of 24 weeks. We will do assessment at baseline, 12th week and 24th week, which include Stop signal task, Digit Span test, Corsi span test, Trail making test, Wisconsin Card Sorting Test; BART -Balloon Analogue Risk Task; YPA – Yoga performance assessment; Work and Social Adjustment Scale (WSAS), symptoms severity with COWS(Clinical opiate withdrawal scale). 
Intervention  Yoga Therapy and Treatment as usual  Yoga module for Substance use disorder during Acute withdrawal phase and Maintenance phase is given along with treatment as usual for the intervention group. The intervention is for 24 weeks. During intervention period Yoga session will be conducted for a duration of 45 min, five days a week. We will do assessment at baseline, 12th week and 24th week, which include Stop signal task, Digit Span test, Corsi span test, Trail making test, Wisconsin Card Sorting Test; BART -Balloon Analogue Risk Task; YPA – Yoga performance assessment; Work and Social Adjustment Scale (WSAS), symptoms severity with COWS(Clinical opiate withdrawal scale). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Diagnosis of Opioid use disorder.
Subjects with mild to moderate severity of withdrawal symptoms (Clinical
Opiate
Withdrawal Scale: COWS score below 24).
Subjects who got admitted into CAM, NIMHANS, and started treatment with
Buprenorphine.
Age range: 18 to 45 years.
Both genders.
Written informed consent. 
 
ExclusionCriteria 
Details  COWS score more than 25.
Patients not willing to give informed consent.
History of current medical illness that may significantly affect brain
functions.
Patients with intractable pain due to other diseases and those on
prescribed opioids for the pain of other medical conditions.
Impaired general intellectual functioning (Mini-Mental Status Exam,
MMSE below 24).
Past history of head injury or concomitant severe medical conditions.
With co-morbid (alcohol/benzodiazepine/cannabis or multiple)
substance dependence except nicotine.
Subjects who had received specific yoga practices for OUD in the
past.
Pregnant or post-partum subjects. 
 
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 
Stop signal task.
Number and Frequency of Relapsing episodes. 		 Baseline, 3 months, 6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Opiate Withdrawal Scale (COWS)
Digit Span Test (DST) - Forward and Backward
Corsi span test (CST)
Trail Making Test (TMT)
Wisconsin Card Sorting Test (WCST)
Balloon Analogue Risk Task (BART)
Stop signal task with fMRI 		 Baseline, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   20/07/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [yogaforstress.nimhans@gmail.com].

  6. For how long will this data be available start date provided 01-03-2030 and end date provided 01-01-2033?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Patients diagnosed with opioid use disorder are assessed for severity of withdrawal symptoms using Clinical Opiate Withdrawal Scale (COWS). The patients with mild to moderate severity of withdrawal symptoms and taking buprenorphine for management of symptoms are randomized into two groups that is intervention group Yoga + standard treatment group and control group Treatment as usual + Interactive health education and stretching exercises. Duration of intervention is 24 weeks. Clinical history will be done at baseline. Assessments will be done at the baseline, 3 months and 6 months. An interview will be done at the end of 1 year to assess relapse and frequency of opioid use. Safety assessments and adverse events will be monitored and appropriately documented for the duration of study period.
 
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