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CTRI Number  CTRI/2022/05/042660 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 02/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Is add-on yoga effective for patients with opioid dependence 
Scientific Title of Study   Real world effectiveness of add-on yoga for patients with opiod dependence stabilized on treatment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siddharth Sarkar 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Psychiatry and NDDTC, Room no 4096, Teaching block
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  9786022145  
Fax    
Email  sidsarkar22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Siddharth Sarkar 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Psychiatry and NDDTC, Room no 4096, Teaching block
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  9786022145  
Fax    
Email  sidsarkar22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Siddharth Sarkar 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Psychiatry and NDDTC, Room no 4096, Teaching block
All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India 
Phone  9786022145  
Fax    
Email  sidsarkar22@gmail.com  
 
Source of Monetary or Material Support  
Department of Science and Technology, Government of India 
 
Primary Sponsor  
Name  Department of Science and Technology Government of India 
Address  Department of Science and Technology, Technology Bhawan, New Delhi-110016 
Type of Sponsor  Government funding agency 
 
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 Siddharth Sarkar  All India Institute of Medical Sciences, New Delhi  Department of Psychiatry and NDDTC, All India Institute of Medical Sciences, Ansari Nagar
South
DELHI 
9786022145

sidsarkar22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, New Delhi  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-WaitlistWaitlist control
2Intervention ArmLifestyle--Dinacarya: None, Ritucarya: None, Acara Rasayana:None, Other:Panchkosha Meditation: further details in procedure (Duration 8 weeks), Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient having a diagnosis of opioid dependence as per ICD 10 diagnostic criteria
2. Age more than 18 years
3. On stable treatment for opioid dependence defined by unchanged medication for last 30 days and adherence of more than 80% in last 30 days, and do not need an immediate change in medication regimen
4. Willing to do meditation at least 5 days a week for at least 1 month
 
 
ExclusionCriteria 
Details  1. Unwilling to participate in the study
2. Concurrently receiving psychotherapy or already practicing yoga (at least once a week) in last 1 month.
3. Currently in clinically significant substance intoxication or withdrawal that interferes with assessment
4. Presence of medical illness that interferes with assessment
5. Presence of psychotic illness or hypomania/ mania currently or in the past
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of add-on yoga for improvement in quality of life (as measured with WHOQOL Bref) in patients with opioid dependence  4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the acceptability and of add-on yoga programme for patients with opioid dependence  0 weeks, 4 weeks, 8 weeks 
To assess the adherence to meditation practice in patients with opioid dependence who are enrolled into add-on yoga programme  8 weeks 
To assess the reduction of substance use with yoga practice in patients with opioid dependence who are enrolled into add-on yoga programme  4 weeks, 8 weeks, 6 months and 12 months 
To assess the improvement in sleep quality with yoga practice in patients with opioid dependence who are enrolled into add-on yoga programme  4 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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 3 
Date of First Enrollment (India)   01/06/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This  study spanning eight weeks duration would be conducted at the National Drug Dependence Treatment Centre (NDDTC), Ghaziabad and Trilokpuri Community Clinic, Delhi. Adult patients with opioid dependence who are currently stabilized on medications and willing for meditation-based intervention would be recruited in the study after obtaining informed consent. They would be assessed on baseline socio-demographic and substance use parameters. Quality of life would be assessed using WHOQOL Bref. The current substance use pattern would be assessed using Maudsley Addiction Profile. Sleep quality would be assessed using Pittsburg Sleep Quality Index (PSQI). The reasons of non-inclusion would also be assessed for those who do not intend to take part in the study.

The patients would be subsequently randomized using a computer-generated sequence into dhyana meditation group and wait-list control. Both the group would also be read-out a leaflet on relaxation. The yoga group would be taught about process of yoga by a trained teacher, preferably on the same day of baseline assessment. The training would be conducted individually or in groups of up to 4 participants. The participants in the yoga group would be encouraged to practice yoga and meditation for at least 30 minutes, at least 5 days a week. The participants would be asked to keep a daily log of yoga, mentioning whether they were able to do the dhayana, how much time they spent, whether they were able to concentrate, and whether they had any problems. A booster session at 2 to 4 weeks would be conducted to reinforce the technique, and to clarify any doubts.

At 8 weeks, all the participants would be assessed for their quality of life using WHOQOL Bref. Other substance use would also be identified using Maudsley Addiction Profile. Sleep would be assessed using PSQI. Feedback would be taken from the participants at the end of 8 weeks. The participants would also be followed up at 6 months and 12 months to assess their substance intake. 

 
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