Experience of patients on methadone maintenance treatment receiving take-home methadone doses during COVID-19 pandemic: A multi-site study from India.

BACKGROUND: Methadone take-home doses for opioid dependence treatment are strictly regulated due to diversion and overdose concerns, so patients must visit the clinic daily for dispensing. This was also done in India until the COVID-19 pandemic, when lockdown restriction compelled take- home dispensing of methadone. This study examined experience of patients who received take- home methadone during COVID-19 pandemic in India. METHODS: Observational, cross-sectional design. We contacted all consenting methadone centres in India during the lockdown and selected those that provided take-home doses for the study. Patients who received daily methadone before the lockdown and take-home doses after were interviewed using a study-specific questionnaire. RESULTS: The study had 210 participants. Take-home methadone was dispensed for 2.5 days on average in each dispensing. When taking methadone at home, 3.3% split their dose 25% took less than the prescribed dose to save it for a rainy days, and 3.3% reported an overdose episode. Adherence improved in 58.6% participants after take-home methadone. Participants perceived many benefits from take-home methadone such as reduced hospital visits and travel time to collect methadone, improvement in work, and financial savings. About 54.3% participants reported storing their take-home doses safely, and 1.9% reported that their family consumed methadone by mistake. CONCLUSIONS: Take-home methadone was found to be beneficial to most participants in terms of time saved and improved productivity. Preconceived concerns of providing take-home methadone in terms of its overdose, diversion, or accidental ingestion by others are not commonly seen when individuals are provided take-home doses of methadone.

Exploring the pharmacological and chemical aspects of pyrrolo-quinazoline derivatives in Adhatoda vasica.

Adhatoda or Justicia is one of the biggest and complex genera of the Acanthaceae family. Adhatoda vasica is commonly known as 'Adosa'. It is an ayurvedic medicine with a medicinal history of more than a thousand years in India. Traditionally, it is used to treat cough, asthma, phlegm, bleeding hemorrhoids, for both adults and youth. This plant possesses antiarthritis, antiseptic, antimicrobial, anti-tuberculosis, anti-inflammatory and abortifacient properties. Alkaloids are the major phytoconstituents present in the plant in the form of pyrrolo-quinazoline derivatives viz vasicine, vasicinone, vasicinol, adhatodine, adhatodinine, adhavasinone and anisotine etc. The asserted objectives are to conduct a systematic review on the phytochemistry, pharmacology and traditional uses of A. vasica, as well as highlighting the challenges found in the research. This will promote the utilization of A. vasica at extract level and further development of new drug leads based on the compounds isolated and used for treatment of various ailments. The present review covers the literature survey from 1888 to 2023. The relevant data has been collected from various peer-reviwed journals, and books via Sci-Finder, PubMed, Science Direct, Google Scholar, EBSCO, online electronic journals, SpringerLink and Wiley. This paper aims to present a systematic review of known traditional applications, pharmacological and chemical aspects in Adhatoda vasica.

Trazodone for sleep disturbance in opioid dependent patients maintained on buprenorphine: A double blind, placebo-controlled trial.

BACKGROUND: Sleep disturbances are seen even in individuals on opioid agonist treatment (OAT). Established pharmacotherapy for sleep disturbances such as benzodiazepines have misuse potential and increased mortality risk in patients with OAT. No study has explored the role of trazodone on sleep disturbance in individuals maintained on buprenorphine. We aimed to assess the efficacy of trazodone in improving sleep disturbance among individuals maintained on buprenorphine. METHODS: The study was a double-blind, placebo-controlled, parallel, randomised trial. Adult males (18-60 years) stabilised on buprenorphine with Pittsburgh Sleep Quality Index (PSQI) score of above five, without other psychiatric comorbidity were randomised to receive either trazodone (50-150mg per day) or placebo. Sleep-50 questionnaire, Epworth Sleepiness Scale (ESS), Brief Pain Inventory (BPI), Clinical Opiate Withdrawal Scale (COWS), Depression, Anxiety and Stress Scale (DASS)-21, Visual Analogue Scale (VAS) for opioid craving, and PSQI were assessed at baseline and at the end of six weeks. RESULTS: Fifty-one patients were allocated to trazodone arm and 49 to placebo arm. Side-effects of trazodone were minimal and well-tolerated with comparable discontiuation rates between both groups. Significantly greater proportion of patients on trazodone (82%, mean dose 101.9 mg) had PSQI scores five or less than those on placebo (16%) at the end of six weeks. Sleep improvement was in various components like sleep quality, latency, efficiency, and duration of sleep. CONCLUSION: Trazodone is well-tolerated and effective in improving sleep disturbances in individuals with opioid dependence maintained on buprenorphine over a six-week period.

Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication.

BACKGROUND: The balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. OBJECTIVES: The focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. METHODOLOGY: We report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). RESULTS: Final aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. CONCLUSION: The initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities.

Does ethyl glucuronide in hair correlate with alcohol consumption? A comparative study with other traditional biomarkers among individuals with alcohol dependence syndrome.

AIM: Ethyl glucuronide (EtG) in hair is a direct biomarker proven to be useful for the detection of chronic excessive alcohol use. This study investigated the association of self-reported alcohol consumption with traditional biomarkers: GGT, AST, ALT, CDT, and MCV in blood and a direct biomarker, hair EtG, in a total of 122 patients with alcohol dependence syndrome. The diagnostic accuracy of the biomarkers to differentiate heavy from non-heavy drinkers was also evaluated. METHOD: GGT, AST, and ALT in serum were measured by Automated Chemistry Analyzer, MCV in blood was measured by Haematology Analyzer, serum CDT was analyzed by ELISA, and EtG in hair was evaluated by gas chromatography-mass spectrometry. The association between the biomarkers and the amount of alcohol consumed (self-reported) was determined using Spearman's rank correlation. RESULTS: All participants showed EtG level above the cut-off (0.03 ng/mg). Hair EtG showed a statistically significant linear and positive correlation with the amounts (in grams) of alcohol consumed (r = 0.60; p < 0.001). No correlation was observed among the traditional biomarkers and the quantity of alcohol consumed. Also, EtG showed an excellent receiver operating characteristic (ROC) curve (98%) with good sensitivity (85%) and specificity (60%) to classify heavy drinkers among individuals with alcohol dependence syndrome. CONCLUSION: Hair EtG can be helpful to estimate retrospective alcohol consumption in long-term chronic alcohol consumption cases. Hair EtG also provides a reliable diagnostic test to detect heavy drinkers among individuals with alcohol dependence syndrome.

Digital Capacity and Interest in mHealth Interventions Among Individuals on Opioid Agonist Maintenance Treatment: A Cross-Sectional Community-Based Study.

Background: Integrating mobile technologies in healthcare (mHealth) is helpful to manage various medical conditions. mHealth applications can bridge the gap in the management of patients with opioid use disorder (OUD). Research evaluating the feasibility of mHealth to address OUD is limited in developing countries. We aimed to assess the digital capacity and interest in mHealth interventions in patients maintained on opioid agonist treatment (OAT). Methods: 150 patients on OAT from a community drug treatment clinic in New Delhi, India, were included. We assessed the participants on their pattern of mobile and Internet use and their willingness to use mHealth technology to access health information and services related to OUD. Results: 88% of participants (n = 132) owned a mobile phone at assessment; 2.7% (n = 4) had never used a mobile phone in their lifetime. 70% (n = 105) participants had Internet access. 80% (n = 120) of participants showed interest in receiving text messages related to the management of OUD. 60% of participants showed a willingness to download and use applications for monitoring their substance use. Conclusions: In India, there is an interest among people on OAT to use mHealth interventions to manage their substance use. This population also has access to mobile phones and the necessary knowledge to install and run applications needed for various mHealth interventions.

Effect of chronic opioid use on the hematological and inflammatory markers: A retrospective study from North India.

Background: Chronic opioid use affects biological functioning implicating the hematopoietic and immune system. It may alter various hematological parameters and inflammatory markers. This study aimed to assess the association of opioid dependence with the hematological parameters and inflammatory markers in the Indian population. Methods: A retrospective chart review was done among opioid dependent (ODS) males and healthy controls (HC) who visited the center's laboratory between Jan 2017 and Dec 2018 for hematological investigations. Clinical records reviewed for opioid use details like type, duration, and route of administration. The hematological profile presented as Mean or median. Mann-Whitney U test was used to compare the hematological parameters between the cases and controls. Results: The study included 191 ODS patients and 123 controls. Among ODS patients, a significant decrease in the levels of hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin and an increase in RBC count and lymphocytes was observed when compared to controls. The inflammatory markers, Neutrophil-Lymphocyte Ratio (NLR) and Platelet-Lymphocyte Ratio, were significantly lower among ODS. Longer duration of opioid use leads to increased NLR among ODS patients. Opioid use by injection did not alter any of the hematological parameters compared to non-injection drug use. Conclusion: Chronic opioid use has a significant effect on the hematopoietic cells. Opioid use for longer durations increases the inflammatory markers suggesting underlying infections.

Evaluation of alcohol use pattern among OST patients using alcohol biomarkers: Report from community clinics in India.

Background: Opioid-dependent patients undergoing opioid substitution therapy (OST) consume alcohol in a hazardous pattern which adversely affects their treatment outcome. This study aims to measure alcohol biomarkers to screen for secondary alcohol use in OST patients. Methods: A pilot study was planned to measure alcohol biomarkers (AST, ALT, GGT, and CDT) to assess alcohol use in OST patients from three community clinics. The biomarkers were categorized based on the reported frequency of alcohol use. The association of the biomarkers with the frequency of alcohol consumption was determined using the post hoc (Mann-Whitney) test. Results: Forty-five patients with a mean (SD) age of 37.04 (10.7) years were included in the study. Alcohol intake was reported in daily, weekly, and monthly patterns by 22, 63, and 16% of the patients, respectively. High levels of ALT, GGT, and CDT were measured in patients with daily use of alcohol. Serum CDT levels significantly differentiate daily and weekly use from monthly consumption of alcohol. Conclusions: Alcohol biomarkers significantly predict the pattern of alcohol use among OST patients. These results can be prudent in low-resource community clinics to improve the overall outcomes of OST in India.

Physical and mental health status of women whose spouses inject drugs - A cross-sectional, multisite study.

Substance use disorder impacts the lives of significant others, more especially the wives of individuals using substances. However, the physical and mental health issues among wives of people who inject drugs (PWID) are less studied. The current cross-sectional, multisite study assessed the physical and mental health of wives of 433 PWID across six sites in Delhi. The mean age of the participants was 32.7 years (standard deviation: 9.7). More than 50% of the participants reported menstrual problems, most commonly dysmenorrhea. Around 55.9% had adverse pregnancy outcomes (abortion, miscarriage, or stillbirth). Around one out of four participants reported at least one specific sexually transmitted infection symptom. Around 11% were diagnosed with tuberculosis and 35% with a major medical illness in their lifetime. More than 90% of the participants had depressive and anxiety symptoms. The study showed that there is a huge burden of physical and mental health issues among the wives of PWID.

Safety and procedural outcomes of intravascular lithotripsy in calcified coronaries in Indian patients.

OBJECTIVE: Calcified coronaries still remain a major challenge for interventional cardiologist. This study aims to evaluate safety and efficacy of intravascular lithotripsy (IVL) in management of coronary artery calcification. METHODS: This was a retrospective single centre study regarding the utility of IVL in management of calcified coronaries. Patients with hemodynamically stable acute coronary syndrome or symptomatic chronic coronary syndrome (CCS) and calcified coronaries on angiography and who underwent IVL were enrolled. Intravascular imaging was performed wherever feasible. The primary endpoint was procedural success. In addition, data regarding procedural complications were collected. RESULTS: A total of 29 patients underwent IVL with a majority being males and having comorbidities such as hypertension and diabetes. A procedural success rate of 93.1% was achieved with no patient having >50% residual stenosis. IVL catheter was successfully delivered in all patients. The mean catheter diameter was 3.3 ± 0.4 mm and mean number of delivered pulses was 70.3 ± 16.4. The arteries most commonly intervened were the left main coronary and the left anterior descending artery. Intracoronary imaging revealed a significant increase in minimum luminal cross-sectional area (MLA) post IVL (pre-MLA: 5.1 ± 2.5 mm2; post-MLA: 10.7 ± 2.9 mm2; P<0.001). Two patients had in-hospital MACE in form of peri-procedural non Q-wave MI. No patient had arrhythmias, stent thrombosis, coronary perforation, or slow flow/no-reflow. Two patients had a rupture of IVL balloon while four had coronary artery dissection. CONCLUSIONS: IVL is a safe and highly effective modality with high procedural success rate in management of calcified coronaries.

Validity of Categories Related to Gender Identity in ICD-11 and DSM-5 Among Transgender Individuals who Seek Gender-Affirming Medical Procedures.

BACKGROUND/OBJECTIVE: The most recent versions of the two main mental disorders classifications-the World Health Organization's ICD-11 and the American Psychiatric Association's DSM-5-differ substantially in their diagnostic categories related to transgender identity. ICD-11 gender incongruence (GI), in contrast to DSM-5 gender dysphoria (GD), is explicitly not a mental disorder; neither distress nor dysfunction is a required feature. The objective was compared ICD-11 and DSM-5 diagnostic requirements in terms of their sensitivity, specificity, discriminability and ability to predict the use of gender-affirming medical procedures. METHOD: A total of 649 of transgender adults in six countries completed a retrospective structured interview. RESULTS: Using ROC analysis, sensitivity of the diagnostic requirements was equivalent for both systems, but ICD-11 showed greater specificity than DSM-5. Regression analyses indicated that history of hormones and/or surgery was predicted by variables that are an intrinsic aspect of GI/GD more than by distress and dysfunction. IRT analyses showed that the ICD-11 diagnostic formulation was more parsimonious and contained more information about caseness than the DSM-5 model. CONCLUSIONS: This study supports the ICD-11 position that GI/GD is not a mental disorder; additional diagnostic requirements of distress and/or dysfunction in DSM-5 reduce the predictive power of the diagnostic model.

ANTECEDENTES/OBJETIVO: Las versiones más recientes de las clasificaciones de trastornos mentales ­CIE-11 de la Organización Mundial de la Salud y DSM­5 de la Asociación Psiquiátrica Americana­ difieren en sus categorías diagnósticas relacionadas con la identidad transgénero. La discordancia de género (DiscG) de la CIE-11, en contraste con la disforia de género (DisfG) del DSM-5, no es considerada un trastorno mental; el distrés y la disfunción no son características requeridas para el diagnóstico. El objetivo fue comparar los requisitos diagnósticos de la CIE-11 y el DSM-5 en términos de sensibilidad, especificidad y capacidad para discriminar casos y predecir el uso de procedimientos médicos de afirmación de género. MÉTODO: 649 adultos transgénero de seis países completaron una entrevista estructurada retrospectiva. RESULTADOS: De acuerdo con el análisis ROC, la sensibilidad de ambos sistemas fue equivalente, aunque la CIE-11 mostró mayor especificidad que el DSM-5. Los análisis de regresión indicaron que la historia de uso de hormonas o cirugía se predijo por variables intrínsecas a la DiscG/DisfG y no por el distrés o disfunción. Según los análisis de respuesta al ítem (TRi) la formación CIE-11 resulta más parsimoniosa y contiene mayor información sobre los casos. CONCLUSIONES: Se aporta evidencia a favor de que la DiscG/DisfG no es un trastorno mental; los criterios diagnósticos adicionales de distrés y/o disfunción del DSM-5 reducen su poder predictivo.

Improving Treatment of Substance Use Disorders through Community Drug Treatment Clinics: An Experiential Account.

India has a huge burden of substance use disorder (SUD). The national response to the problem of SUD has been to support addiction treatment centers either in government hospitals or in nongovernmental settings. The existing number of addiction treatment facilities is less compared to the burden of substance use in India. The existing models of treatment in India place undue emphasis on inpatient treatment of SUD. Community-based treatment aims to bring the treatment of SUD closer to the patients in their community. Community-based treatment of SUD utilizes existing services available in the community by establishing an integrated network of community-based services. There have been different models of community-based care for the management of SUD in India. Most of them, however, address short-term withdrawals and do not provide long-term treatment in community. National Drug Dependence Treatment Centre, AIIMS, New Delhi, has been providing community-based treatment for SUD since the 1990s. Two of the three community drug treatment clinics (CDTCs) are in operation for more than 5 years now and cater to the population residing within a defined catchment area. The CDTCs use infrastructure available in the community to operate the clinics. The clinics are run daily by a team of nursing staff, while the doctor is available only twice a week. A menu of options, ranging from short-term treatment to long-term agonist maintenance treatment is provided in the clinic. Both pharmacotherapy and psychosocial interventions are provided. Each clinic caters to hundreds of patients through these facilities. There is a need to expand CDTCs in India considering their cost-effectiveness, acceptability, and overall effectiveness, especially in urban colonies with higher substance-related problems.

Mobile methadone dispensing in Delhi, India: implementation research.

OBJECTIVE: To assess the implementation of a mobile dispensing service to improve opioid users' access to methadone maintenance therapy. METHODS: In March 2019, we started mobile methadone dispensing in an urban underprivileged locality in Delhi, India. The doctor was available only at the main community drug treatment clinic for clinical services, while the nurse dispensed methadone from a converted ambulance. We involved patients in identifying community leaders for sensitization and in deciding the location and timings for dispensing. We conducted a retrospective chart review of the programme data collected during delivery of clinical services. We compared the numbers of patients registered for methadone therapy and their retention and adherence to therapy in the 12-month periods before and after implementation of the mobile service. FINDINGS: The number of patients registered for therapy at the clinic increased from 167 in the year before implementation to 671 in the year after. A significantly higher proportion of patients were retained in therapy at 3, 6 and 9 months after enrolment; 9-month retention rates were 19% (32/167 patients) and 45% (44/97 patients) in the year before and after implementation, respectively. There was no significant difference in patients' adherence to therapy between the two periods. Challenges included providing suitable dispensing hours for patients in employment and concerns of local community near to the dispensing sites. CONCLUSION: It is feasible to dispense methadone by a mobile team in an urban setting, with better retention rates in therapy compared with dispensing through a stationary clinic.

Cognitive functioning in patients maintained on buprenorphine at peak and trough buprenorphine levels: An experimental study.

OBJECTIVES: To assess the cognitive functions in participants maintained on buprenorphine for opioid dependence at peak and trough buprenorphine levels. METHODS: This was a double-blind, randomized, experimental study. Sixty participants maintained on buprenorphine were matched for age and education and randomly allocated to "peak" group or "trough" group. The "peak" group received buprenorphine two hours before assessment, whereas the trough group received placebo. The cognitive domains of attention, learning and memory, and executive function including fluency, working memory, response inhibition and set shifting were tested. RESULTS: The two groups were comparable on socio-demographic, substance use profile and opioid agonist treatment-related characteristics. Significant differences in performance of peak and trough group were observed on Wisconsin Card Sorting Test parameters of number of correct responses (U = 289.00, p = 0.03), number of errors (t = 02.26, df = 58, p = 0.03), and perseverative errors (U = 301.50, p = 0.04). CONCLUSIONS: The time since buprenorphine dose has significant relation on specific cognitive tasks in patients maintained on buprenorphine for opioid dependence.

Left atrial high-grade rhabdomyosarcoma; an unusual location.

A 63-year-old diabetic and hypertensive lady presented in New York Heart Association class III-IV dyspnea on exertion. Echocardiography showed a large mass attached to the anterior mitral leaflet and the base of the interatrial septum. After removal of the mass and excision of the anterior and posterior mitral leaflets, a bioprosthetic valve was deployed. The postoperative course was uneventful. Histopathology showed that the tumor was a high-grade rhabdomyosarcoma. Although it is a highly lethal tumor, surgical removal was indicated to relieve dyspnea, clarify the diagnosis, and improve short-term survival. Our patient survived for 8 months after surgical excision.

Sildenafil Misuse for its Psychoactive Properties? A Case Report.

Sildenafil is a widely used drug for the treatment of erectile dysfunction in a dosage ranging from 50 to 100 mg per day. Recreational use is reported among youth for its sexual function enhancing effects. To date, however, no study has reported the use of sildenafil for its nonsexual, psychoactive effects. We report a case of a 38-year-old male with opioid and sedative use disorder who self-administered sildenafil orally in a dose of up to 2000 mg per day for its psychoactive effects (primarily) for 10 years before seeking treatment and discuss the literature relevant to the case.

Mental illnesses and related vulnerabilities in the Hijra community: A cross-sectional study from India.

PURPOSE: The Hijra community is a cultural and gender grouping in South Asia broadly similar to western transgender communities, but with literature suggesting some differences in gender experience and patterns of psychosocial adversity. The present study aims to describe patterns of mental illness and psychoactive substance use in Hijra subjects and study their association with gender experience and psychosocial adversity. METHODS: Fifty self-identified Hijras availing HIV-prevention services in New Delhi, India, were interviewed. Data on mental disorders, psychoactive substance use, quality of life, discrimination, empowerment, violence and gender identity were assessed using structured instruments. RESULTS: Subjects were mostly in their mid-twenties, and had joined the Hijra community in their mid-teens. More subjects (46%) were involved in begging than in traditional Hijra roles (38%). Sex work was reported by 28% subjects. The rates of lifetime mental illness was 38%, most commonly alcohol abuse (26%); others had anxiety or depressive disorders (8% each), somatoform disorders (6%) and bulimia nervosa (n = 1). Disempowerment was mostly experienced in domains of autonomy and community participation; 52% had experienced sexual or psychological violence. Discrimination was attributed to gender (100%), appearance (28%) or sexual orientation (28%). There were negative correlations between the physical domain of WHO-QOL and physical violence and depression scores; and between discrimination and WHO-QOL environmental, physical and psychological domains. CONCLUSIONS: This Hijra group showed high rates of mental disorder and substance involvement, related to QOL domains and experiences of discrimination and disempowerment.