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Effect of 6-month yoga practice on addiction severity in opioid/heroin drug addicts

Not Applicable
Conditions
Health Condition 1: F112- Opioid dependence
Registration Number
CTRI/2023/03/050737
Lead Sponsor
DBT/Wellcome Trust India Alliance (India Alliance)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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), <br/ ><br>Cortisol, Buprenorphine Dosage and Side-effects(UKU), and Vedic Personality Inventory(VPI) for Gunas.Timepoint: 15 days, 3 months, 6 months
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