Development, Validation, and Feasibility Testing of a Yoga Module for Opioid Use Disorder.

CONTEXT: Opioid use disorder (OUD) involves excessive use of opioids-such as heroin, morphine, fentanyl, codeine, oxycodone, and hydrocodone-leading to major health, social, and economic consequences. Yoga lifestyle interventions have been found to be useful as adjunct therapies in management of substance use disorders and chronic pain conditions. OBJECTIVE: The research team intended to develop, validate, and test for feasibility a yoga program for OUD patients that could reduce opiate withdrawal symptoms-such as pain, fatigue, low mood, anxiety and sleep disturbances-and cravings associated with drugs. DESIGN: The research team first performed a literature review of traditional and contemporary yoga texts, such as Hatha Yoga Pradipika and Light on Yoga, as well as modern scientific literature in the following search engines-Google Scholar, PubMed, and PsychInfo, using the keywords yoga, pranayama, hatha yoga, relaxation. meditation, substance use, addiction, impulsivity, craving, sleep quality, and fatigue. Using the information obtained, the team developed a yoga program and designed a pilot study that used the program. SETTING: The study took place in the Department of Integrative Medicine at the National Institute of Mental Health and Neurosciences (NIMHANS) in Bangalore, India. PARTICIPANTS: Participants in the pilot study were 8 inpatients, 6 males and 2 females, who were on opioid agonist treatment (buprenorphine) for OUD. INTERVENTION: The intervention was the yoga program previously validated by the research team. In the pilot study, participants were taught a one-hour, yoga-based intervention, with sessions occurring once per day, for 10 sessions. OUTCOME MEASURES: For validation, 13 experts scored the yoga program that the research team had developed and gave suggestions for each yogic practice for use during the acute phase of withdrawal and the maintenance phase respectively. A content validity ratio (CVR) was calculated from their scoring, and the research team made changes to the program base on the scoring and suggestions. For the pilot study, assessments occurred at baseline and postintervention. The participants' yoga performance was rated by the yoga trainer on a yoga performance assessment scale (YPA). Other measurements included: (1) the Clinical Opiate Withdrawal Scale (COWS), (2) the Hamilton's anxiety rating scale (HAM-A), (3) the Hamilton's depression rating scale (HAM-D), (4) buprenorphine dosage, (5) the Clinical Global Impression Severity (CGI-S) scale, (6) a visual analog scale (VAS) for pain, (7) sleep quality (latency and duration), and (8) the module's safety. RESULTS: Four practices were removed from the program due to CVR scores below the cutoff, and one practice was found not to be feasible (Kapalabhati). Two categories of yoga modules emerged: (1) for the acute symptomatic phase (40 minutes) and (2) for the maintenance phase (one hour). Practices were added or excluded based on the phase. CONCLUSIONS: The yoga module that was developed for reducing withdrawal symptoms and cravings in OUD patients was found to be safe, feasible, and potentially useful as an adjunct therapy to conventional treatment.

Opioid use disorder and role of yoga as an adjunct in management (OUDARYAM): Study protocol for a randomized controlled trial.

Background: The proposed research aims to test the effects and mechanisms of a six-month yoga-based intervention as an add-on to standard treatment in opioid use disorder (OUD) by conducting a randomized controlled study with the following primary outcome variables: 1) clinical: abstinence (opioid negative urine test), and reductions in pain and craving, and 2) mechanisms: reward circuit activation in response to opioid visual cue craving paradigm, activation in response to a cognitive control task, and resting state functional connectivity through fMRI, and plasma beta-endorphin levels. Secondary outcome variables are perceived stress, anxiety, sleep quality, cognitive performance, pain threshold, buprenorphine dosage and side effects, withdrawal symptoms, socio-occupational functioning, vedic personality traits, heart rate variability, serum cortisol, and brain GABA levels through magnetic resonance spectroscopy (MRS). Methods: In this single-blinded, randomized, controlled, parallel-group superiority trial with 1:1 allocation ratio, 164 patients with OUD availing the outpatient/ inpatient clinical services at a tertiary mental healthcare hospital in India will be enrolled after giving informed consent. Consecutive consenting patients will be randomly allotted to one of the two groups - yoga arm (standard treatment + yoga-based intervention), or waitlist group (standard treatment alone). Allocation concealment will be followed, the clinicians, outcome assessors and data analysts will remain blind to subject-group allocation. A validated and standardized yoga program for OUD will be used as an intervention. Participants in the yoga arm will receive 10 supervised in-person sessions of yoga in the initial two weeks followed by tele-yoga sessions thrice a week for the next 22 weeks. The wait-list control group will continue the standard treatment alone for 24 weeks. Assessments will be done at baseline, two weeks, 12 weeks, and 24 weeks. Data from all randomized subjects will be analysed using intent-to-treat analysis and mixed model multivariate analysis. Dissemination: Findings will be disseminated through peer-reviewed publication, conference presentations, and social media. Trial registration number: The trial has been registered under Clinical Trials Registry-India with registration number CTRI/2023/03/050737.