How Yoga can help in Opium addiction recovery: A study on holistic well being

Efficacy of Integrated Yoga Therapy in Opium Abuse Recovery: A longitudinal randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/089999

Enrollment

Registered

2025-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Integrated Yoga Therapy based module for opium addiction recovery: The study employs a six-phase Panchakosha-based Yoga Module, where each phase comprises of 15 days that unfolds progre

Eligibility

Inclusion criteria

Inclusion criteria: a) Diagnosis of OUD (DSM 5 criteria) b) Score greater than 3 on Clinical Global Impression Severity (CGIS) c) Age range 18 to 60 years d) Male e) Written informed consent f) Geographical Location Residents of rural western Rajasthan

Exclusion criteria

Exclusion criteria: a) Severe withdrawal symptoms (COWS greater than 25) b) other diseases causing intractable pain. c) Prescription opioids for pain related to her medical conditions d) Comorbid alcohol, benzodiazepine, cannabis, etc., multiple substance dependence in last six months except for nicotine e) Impaired intellectual functioning (HMSE more than 24) f) Severe psychiatric or medical illness preventing practice of the yoga program g) Risk of harm to self or others h) Current or recent practice of yoga (more than 4hr per month in last three months)

Design outcomes

Primary

Measure	Time frame
Abstinence: Proportion of participants with opioid-negative urine tests at 3 months and 6 months post-intervention. Craving: Change in scores on the Craving Questionnaire (CCQ) from baseline to 3 months and 6 months.Timepoint: Baseline - 3 Months and 6 Months	—

Secondary

Measure	Time frame
Psychological Well-being: Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Perceived Stress Scale (PSS), Depression Anxiety Stress Scales - Short Form (DASS-21), World Health Organization Quality of Life - BREF(WHOQOL-BREF), Beck Hopelessness Scale (BHS), Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2).Timepoint: Baseline - 3 Months and 6 Months;Physiological Health: Heart Rate Variability (HRV), spirometry, Gut Dysmotility Questionnaire (GDQ), Constipation Scoring System (CSS), Bristol Stool Form Scale (BSFS), o Patient Assessment of Constipation-Symptoms (PAC-SYM), o Bowel Function Index (BFI)Timepoint: Baseline - 3 Months and 6 Months;Biochemical markers: cortisol, beta-endorphins, osteocalcin, prolactin, luteinizing hormone (LH), testosterone, dopamine, serotonin, adrenocorticotropic hormone (ACTH), and routine serum markers.Timepoint: Baseline - 3 Months and 6 Months;Sensory Function Recovery: Tinnitus Handicap Inventory, Taste Strips Test, Chemosensory Questionnaire (CPQ), Quality of Vision (QoV) Questionnaire. Timepoint: Baseline - 3 Months and 6 Months;Withdrawal Symptoms and Adverse Effects: Clinical Opiate Withdrawal Scale (COWS), Udvalg for Kliniske Undersogeleser (UKU) Side Effects Rating Scale.Timepoint: Baseline - 3 Months and 6 Months;Behavioral and Cognitive Enhancement: Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index, Buss-Perry Aggression Scale (BPAQ), cognitive tests (Five-Point Test, Digit Span, Spatial Span, Stroop Color-Word Interference Test, Game of Dice Task), Social Occupational Functioning Scale (SOFS).Timepoint: Baseline - 3 Months and 6 Months;Sustainability of Therapeutic Benefits: : Relapse rates defined as return to opioid use, confirmed by urine drug screens or self-reported via Time-Line Follow Back (TLFB).Timepoint: Baseline - 3 Months and 6 Months	—

Measure

Time frame

Psychological Well-being: Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Perceived Stress Scale (PSS), Depression Anxiety Stress Scales - Short Form (DASS-21), World Health Organization Quality of Life - BREF(WHOQOL-BREF), Beck Hopelessness Scale (BHS), Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2).Timepoint: Baseline - 3 Months and 6 Months;Physiological Health: Heart Rate Variability (HRV), spirometry, Gut Dysmotility Questionnaire (GDQ), Constipation Scoring System (CSS), Bristol Stool Form Scale (BSFS), o Patient Assessment of Constipation-Symptoms (PAC-SYM), o Bowel Function Index (BFI)Timepoint: Baseline - 3 Months and 6 Months;Biochemical markers: cortisol, beta-endorphins, osteocalcin, prolactin, luteinizing hormone (LH), testosterone, dopamine, serotonin, adrenocorticotropic hormone (ACTH), and routine serum markers.Timepoint: Baseline - 3 Months and 6 Months;Sensory Function Recovery: Tinnitus Handicap Inventory, Taste Strips Test, Chemosensory Questionnaire (CPQ), Quality of Vision (QoV) Questionnaire. Timepoint: Baseline - 3 Months and 6 Months;Withdrawal Symptoms and Adverse Effects: Clinical Opiate Withdrawal Scale (COWS), Udvalg for Kliniske Undersogeleser (UKU) Side Effects Rating Scale.Timepoint: Baseline - 3 Months and 6 Months;Behavioral and Cognitive Enhancement: Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index, Buss-Perry Aggression Scale (BPAQ), cognitive tests (Five-Point Test, Digit Span, Spatial Span, Stroop Color-Word Interference Test, Game of Dice Task), Social Occupational Functioning Scale (SOFS).Timepoint: Baseline - 3 Months and 6 Months;Sustainability of Therapeutic Benefits: : Relapse rates defined as return to opioid use, confirmed by urine drug screens or self-reported via Time-Line Follow Back (TLFB).Timepoint: Baseline - 3 Months and 6 Months

—

Countries

India

Contacts

Public ContactArjun Ram Roj

Central University of Rajasthan, Bandarsindri, Rajasthan

2023phdyg001@curaj.ac.in08302291438

Outcome results