Health Condition 1: F112- Opioid dependence
Conditions
Interventions
Intervention1: 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).
Subj
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.
Control Intervention1: Sta
Sponsors
DBT/Wellcome Trust India Alliance (India Alliance)
Eligibility
Inclusion criteria
Inclusion criteria: Patients meeting only with following criteria will be allowed to undergo the trail. a) Diagnosis of OUD (Opioid Use Disorder) (DSM â?? V criteria) b) Score >3 on Clinical Global Impression â?? Severity (CGI-S) c) Age range: 18â??50 years d) All gender e) Written informed consent f) Access to smart phone and internet
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 15 days, 3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 15 days, 3 months, 6 months | — |
Countries
India
Contacts
Public ContactDr Hemant Bhargav
National Institute of Mental Health and Neurosciences
Outcome results
None listed