| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Waitlist | Waitlist control | | 2 | Intervention Arm | Lifestyle | - | - | 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. |