Effectiveness of Interventions Based on Yogic Breathing Practices (IB-YBP) on Substance Use Disorders-A Systematic Review of the Randomized Control Trials and Quasi-Experimental Trials.

INTRODUCTION: Interventions based on Yogic Breathing Practices (IB-YBP) have shown promising results for substance use disorders (SUD). Research in this area is methodologically heterogeneous and only a few, but restricted, systematic reviews are available. The current systematic review aims to assess the effectiveness of IB-YBP for SUD. Materials and Methods: PubMed, Cochrane's Library, EBSCO-Medline, and Google Scholar databases were searched for the randomized- (RCTs) and quasi-randomized trials. Research involving participants with SUD, of either gender or any age, assessing the effectiveness of the IB-YBP either as a standalone intervention or as an adjuvant to standard treatment versus standard pharmacological/non-pharmacological treatment or no-intervention control were included. Studies having participants with co-morbid psychiatric illness and interventions not having IB-YBP as the predominant component were excluded. Results: The initial literature search yielded 396 articles and upon screening, only 14 studies were found eligible for this review. Most studies have researched IB-YBP as an adjunct to the standard treatment for SUD. Evidence for the effectiveness of IB-YBP is mostly available for tobacco and opioid use disorders, though only for short-term outcomes; however, literature is scarce for alcohol- and cocaine-use disorders. This review documented the effectiveness of the IB-YBP for substance use-related outcome parameters such as abstinence, quality of life (QoL), mood, craving, and withdrawal symptoms. Conclusion: IB-YBP may be an effective adjuvant to standard treatment for various SUD. However, more research is required to compare its effectiveness with standard treatment, and assessing its long-term efficacy, for it to be strongly recommended as a treatment strategy.

Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India.

This study examined changes in tobacco craving, withdrawal, and affect as correlates of efficacy in a phase-2 clinical trial of varenicline for smokeless tobacco dependence in India. Smokeless tobacco users (N = 237) at the All India Institute of Medical Sciences were randomized to placebo or varenicline. Abstinence was defined as cotinine-verified seven-day point prevalence cessation at end of treatment (EOT). General Linear Model repeated measures assessed the effects of treatment condition, time, abstinence state, and interaction effects on changes in craving, withdrawal, positive (PA) and negative affect (NA) from baseline to EOT. All participants showed a significant reduction in withdrawal (p < .001), total craving (p < .001), positive reinforcement (PR) craving (p < .001), and NA (p = .02), and an increase in PA (p = .04) from baseline to EOT. However, there were no differences between placebo and varenicline participants in measures of withdrawal, craving, or affect from baseline to week 3 or at EOT. Significant interactions between time and abstinence state were found for total craving (p = .008), PR craving (p < .001), and withdrawal (p = .001), indicating reductions in these processes among those abstinent vs. those still chewing smokeless tobacco. Additional research is needed concerning the effects of varenicline on craving, withdrawal, and affect among smokeless tobacco users.

Biochemical Validation of Self-Reported Smokeless Tobacco Abstinence among Smokeless Tobacco Users: Results from a Clinical Trial of Varenicline in India.

The validity of self-reported tobacco use is often questioned given the potential for underestimation of use. This study used data from a double-blind, placebo-controlled clinical trial of varenicline for smokeless tobacco dependence in India to evaluate the accuracy of self-reported smokeless tobacco cessation using biochemical validation procedures and to evaluate correlates of reporting inaccuracy. Smokeless tobacco users attending a dental clinic at AIIMS were randomized to placebo or varenicline; all participants received counseling. Detailed smokeless tobacco use was recorded and abstinence was defined as cotinine-verified 7-day point prevalence cessation (cotinine < 50 ng/ml) and breath CO > 10 ppm at the end of 12 weeks of treatment. One-half of study completers (82/165) self-reported abstinence. Biochemical verification confirmed that (65.9%) subjects provided accurate self-reports while (34.1%) participants underreported tobacco use. These data indicate poor agreement between self-reported and biochemically confirmed abstinence (κ = -0.191). Underreporters of tobacco use had significantly higher baseline cotinine (p < 0.05), total craving (p < 0.012), and negative reinforcement craving (p < 0.001) vs. those whose self-reports were correctly verified. These findings provide evidence to support the need for biochemical validation of self-reported abstinence outcomes among smokeless tobacco users in cessation programs in India and identify high levels of pretreatment cotinine and craving levels as potential correlates of false reporting.

A double-blind placebo-controlled randomized trial of varenicline for smokeless tobacco dependence in India.

INTRODUCTION: The rate of smokeless tobacco use in India is 20%; its use causes serious health problems, and no trial has assessed behavioral or pharmacological treatments for this public health concern. This trial evaluated varenicline for treating smokeless tobacco dependence in India. METHODS: This was a double-blind placebo-controlled randomized trial of varenicline (12 weeks, 1mg, twice per day) with 237 smokeless tobacco users in India. All participants received behavioral counseling. Outcomes included self-reported and biochemically verified abstinence at the end of treatment (EOT), lapse and recovery events, safety, and medication adherence. RESULTS: Self-reported EOT abstinence was significantly greater for varenicline (43%) versus placebo (31%; adjusted odds ratio [AOR] = 2.6, 95% CI = 1.2-4.2, p = .009). Biochemically confirmed EOT abstinence was greater for varenicline versus placebo (25.2% vs. 19.5%), but this was not statistically different (AOR = 1.6, 95% CI = 0.84-3.1, p = .15). Compared with placebo, varenicline did not reduce the risk for a lapse (hazard ratio [HR] = 0.86, 95% CI = 0.69-1.1, p = .14), but it did increase the likelihood of recovery to abstinence (HR = 1.2, 95% CI = 1.02-1.4, p = .02). Greater adherence increased EOT cessation rates for varenicline (39% vs. 18%, p = .003) but not for placebo (28% vs. 14%, p = .06). There were no significant differences between varenicline and placebo in rate of side effects, serious adverse events, hypertension, or stopping or reducing medication. CONCLUSIONS: Varenicline is safe for treating smokeless tobacco dependence in India, and further examination of this medication for this important public health problem is warranted.

A Review of Intervention Strategies for Areca Nut Use Cessation.

Background: Areca nut (AN) is one of the world's most widely used drugs, especially in Asia-Pacific, causing dependence and multiple adverse health impacts. The International Agency for Research on Cancer (IARC) has classified it as a type-1 carcinogen. Despite evidence of harms, its use is culturally ingrained in many regions worldwide; harm perception is low; and the availability of intervention strategies is limited. Methods: To identify the range and efficacy of interventional studies on AN use cessation, a narrative review of studies published between 1990 and 2021 was undertaken using selected electronic databases (PubMed, Embase, and Scopus). Results: Three types of interventions were identified: educational, psychological, and pharmacological. Overall, educational interventions significantly enhanced knowledge regarding harms related to AN use. Some psychological interventions reported enhancement of motivation to quit as well as helped in reduction/cessation of AN use. Two pharmacological studies on psychiatric patients with depressive disorders and AN use found that antidepressants helped in reducing/cessation of AN use. Conclusion: Overall, the number of interventional studies on AN cessation is limited, and most studies have measured the short-term effects of the intervention. The role of pharmacotherapeutic interventions needs to be evaluated for AN cessation, and evidence-based psychosocial interventions need to be developed for AN cessation. Furthermore, longitudinal research using adequate sample sizes and longer follow-up durations are needed to establish interventions in this important area.

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.

Effectiveness of smoking cessation intervention in opioid-dependent male subjects on buprenorphine maintenance treatment: An open-label trial.

Background: High prevalence (more than 80%) rates of tobacco smoking have been found both in, opioid-dependent subjects and among opioid-dependent subjects on opioid substitution treatment (OST) with buprenorphine or methadone. Aim: We aimed to explore the efficacy of combined nicotine replacement therapy (NRT) and individual counseling (IC) when compared to NRT alone in subjects on OST with buprenorphine. Methods: This study was carried out in a tertiary medical care center. It was an open-label randomized clinical trial. A total of 57 buprenorphine maintained smokers were recruited and randomized into two groups. They were assigned nicotine gum for 4 weeks plus either (1) a baseline IC session, and a second IC session after 1 week, or (2) simple advice to quit. In the first group, 31 subjects received NRT with IC and in the second group, 26 subjects received NRT plus simple advice to quit. The primary outcomes of this study were seven days point prevalence abstinence, biochemically confirmed by carbon monoxide (CO) breath analyzer, and reduction in smoking (mean no. of cigarettes or bidis/day). The smoking behavior during the 4 weeks follow-up period was assessed by the timeline follow-back (TLFB) method and confirmed by the CO breath analyzer. Results: The group of subjects who received NRT with IC showed higher rates of smoking cessation at the end of treatment (51%) as compared to the NRT and simple advice group where smoking cessation rates were around 8% (P < 0.001). Conclusion: A multi-component approach (pharmacotherapy and counseling) enhances treatment outcomes and enhances rates of abstinence from smoking.

Concordance between urinary cotinine levels and self-reported tobacco use among drug-dependent persons: a pilot study.

Self-reported drug use is a principle measure in the evaluation of treatment outcome. As there have been concerns about the accuracy of self-reporting, it is necessary to establish its validity by an objective method. The aim of the study was to examine the concordance between urinary cotinine concentrations and self-reported tobacco use among drug dependents seeking treatment at National Drug Dependence Treatment Centre, AIIMS, New Delhi, India. Eighty consecutive male drug addicts attending the OPD at National Drug Dependence Treatment Centre were interviewed by the clinician. Their tobacco as well as drug use history was recorded, and thereafter their urine sample was analyzed for drug testing. Mean age of the subjects was found to be 33 years (SD: 10). Urinalysis showed high concentration of cotinine (mean ± SD: 586.40 ± 222.15 ng/ml) in 95% of the subjects. High concordance was observed between self-report of tobacco use and urinary cotinine. The quantity of tobacco consumption and FTND scores were also correlated with the urinary cotinine levels. Urinalysis also showed misuse of opioids, benzodiazepines and antihistaminics. The treatment for tobacco use has been given low priority in the de-addiction centers. Tobacco is highly prevalent among the drug abusers. The effectiveness of the treatment program may be increased by using the combination of urine analysis along with self-report.

The Fagerström test for nicotine dependence in an Indian sample of daily smokers with poly drug use.

INTRODUCTION: The Fagerström Test for Nicotine Dependence (FTND) is a widely used six-item questionnaire, which has often been used as a measure of physical dependence on nicotine. METHODS: The performance of the FTND was explored in an Indian sample of 75 daily smokers with histories of polysubstance use attending the Tobacco Cessation Clinic at National Drug Dependence Treatment Centre. RESULTS: FTND score was found to be significantly correlated with the age of initiation but showed no correlation with duration of use. FTND had low reliability (Cronbach's alpha: .57) in the Indian setting. An exploratory factor analysis suggested that the FTND comprised 2 factors. Factor 1 was defined by questions regarding "time-to-first cigarette after waking," "difficulty refraining from smoking in forbidden places," and "amount smoked," which reflects the persistence to maintain the nicotine levels during waking hours, whereas Factor 2 was defined by questions regarding "which cigarette is most preferred" and "prominence of morning smoking and "smoking while ill," which explains the degree of urgency to restore nicotine levels to a given threshold after nighttime abstinence. A good amount of variance (56.34%) was explained by these factors. Cronbach's alpha, for each of the 2 domains was found to be .66 and .58, respectively. CONCLUSIONS: FTND was found to have low internal consistency reliability in this study. The study confirms a 2-factor structure of the FTND in a sample of polysubstance users. Thus, the FTND may assess 2 separate dimensions of nicotine addiction.

Impact of nicotine replacement therapy as an adjunct to anti-tuberculosis treatment and behaviour change counselling in newly diagnosed pulmonary tuberculosis patients: an open-label, randomised controlled trial.

We evaluated the impact of intensive smoking cessation activities as an adjunct to anti-tuberculosis treatment on patient-related treatment outcomes. In this open-label, randomised controlled trial, self-reporting smokers with pulmonary tuberculosis who initiated standard anti-tuberculosis treatment were randomised to either nicotine replacement therapy and behaviour change counselling (n = 400) or counselling alone (n = 400) provided at baseline and two follow-up visits. The primary outcomes were change in TBscore at 24-weeks and culture conversion at 8-weeks. Biochemical smoking quit rates defined as serum cotinine levels <10 ng/mL and/or exhaled carbon monoxide levels <6 ppm (47·8% vs 32·4%, p-value =< 0·001) and self-reported quit rates (69.3% vs 38·7%, p-value =< 0·001) were significantly higher in the intervention arm at 24-weeks. Though the TBscores at 24 weeks (95% CI) were lower in the intervention arm [2·07 (1·98, 2·17) versus 2.12 (2·02, 2·21)], the difference was not clinically meaningful. Patients in the control arm required treatment extension more often than intervention arm (6·4% vs 2·6%, p-value = 0·02). Combining nicotine replacement therapy with behaviour change counselling resulted in significantly higher quit rates and lower cotinine levels, however, impact on patient-related (TBscore) or microbiological outcomes (culture conversion) were not seen.

A Randomized Pilot Study of Brief Intervention versus Simple Advice for Women Tobacco Users in an Urban Community in India.

AIM: The study aimed to assess the efficacy of providing brief intervention (BI) for women tobacco users in a community-based setting. METHODS: In this open-labeled randomized study, a representative sample of women (n = 100) from a community in East Delhi were screened using Alcohol, Smoking and Substance Involvement Screening Test. Eligible women were randomized to BI or simple advice (SA) arms. At baseline, they were assessed for tobacco use characteristics and severity of nicotine dependence using Fagerstrom's test for nicotine dependence. Intervention in the form of a single session of BI or SA to quit tobacco was provided at baseline. All participants were assessed at 1 week and 3 months following intervention. The principal outcome was self-reported abstinence from tobacco use at 3 months follow-up. RESULTS: The mean age of the sample was 43 years (standard deviation = 13). Most women were married (80%), housewives (69%), illiterate (61%), socioeconomically disadvantaged and were smokeless tobacco users (94%). The subjects in the BI group were twice more likely to stop tobacco use as compared to individuals in the SA group (odds ratio = 2.2, 95% confidence interval: 0.962-5.197, P = 0.06). CONCLUSION: The study results are suggestive of beneficial effect of BI. A larger study might provide more significant results.

Factors Affecting Drug Use During Incarceration: A Cross-Sectional Study of Opioid-Dependent Persons from India.

INTRODUCTION: Substance abuse and criminality share a complex relationship. The rates of substance use among the prisoners, and that of criminal acts among substance users in community setting are high. Data from South Asian countries, including from India are inadequate. This study aimed to assess the pattern of criminal acts among opioid-dependent subjects and their substance use pattern in the month before, during and after imprisonment. METHODS: Using a cross-sectional study design and purposive sampling, opioid-dependent subjects (n=101) attending two community drug treatment clinics who have had any contact with the law were assessed using a specifically-designed tool to record criminal acts and substance use before, during and after last imprisonment. RESULTS: Most subjects (93%) had committed illegal acts in their lifetime. Physical assault was the most common illegal act, while 23% reported selling drugs and 9% reported committing serious crimes. About 95% were arrested and 92% had spent time in police lockups. About 29% were arrested for drugs possession or drug use, and 3% of injecting drug users arrested for carrying injection equipment. About 85% had been imprisoned at least once, of whom 88% used psychoactive substances in the 1-month period before their last imprisonment. Opioids were the most common substances used daily (68%), followed by cannabis (34%) and alcohol (22%). Ninety-seven percent reported the availability of substances in prisons, and 65% also used substances during their last imprisonment. Cannabis (35%) was the most common substances used in prison followed by opioids (19%). Seventy-six percent used substances soon after prison release, and 13% of opioid users experienced opioid overdose soon after prison release. Use of cannabis, injecting drugs, and opioid use before imprisonment were predictors of substance use in prison. CONCLUSION: Opioid-dependent people have various contacts with the law, including imprisonment. Many users are dependent on substances during prison-entry, which is an important reason for their continued substance use in prisons. There is a need to provide substance abuse treatment across all stages of criminal justice system.

Psychological Barriers to Tobacco Cessation in Indian Buprenorphine-Naloxone Maintained Patients: A Pilot Study.

CONTEXT: The prevalence of smoking in opioid agonist treatment programmes remains high, leading to significant tobacco related health hazards and mortality. This is the first study from India addressing tobacco cessation and related barriers among recipients of buprenorphine-naloxone maintenance treatment. AIMS: The purpose of the study was to investigate Indian buprenorphine-naloxone maintained patients' willingness to quit tobacco use, to determine its possible association with demographic, agonist maintenance treatment, tobacco use related variables and personal health and risk perceptions related to health hazards associated with tobacco use. SETTINGS AND DESIGN: The study was cross-sectional, observational. It was conducted in the out-patient department of a national level de-addiction centre in India. MATERIALS AND METHODS: Fifty-five males on buprenorphine-naloxone treatment were assessed using Tobacco Use Characteristics, Fagerstrom Test for Nicotine Dependence (FTND and FTND-ST), Readiness to Change questionnaire (RCQ), Smoker's Perceived Health Risk Evaluation (SPHERE), Importance of Intervention scale and a semi-structured questionnaire. STATISTICAL ANALYSIS: Descriptive statistics, Kruskal-Wallis Chi-square test, Spearman rank order correlation, paired-t test, ANOVA (STATA 9.2 statistical package). RESULTS: Around 65.4% of the subjects were smokers, 9% were using smokeless tobacco only whereas 25.6% were using both. Mean duration of tobacco use was 20 ± 1.5 years. Only 20% had past quit attempts. Only 24% were in action phase of change. Personal health and risk perceptions were poor and only 61.62% considered intervention tobacco smoking cessation important. CONCLUSIONS: Higher severity of nicotine dependence, low perception of harm from tobacco warrant immediate attention and need for on-site treatment opportunity.

Evidence based psychosocial interventions in substance use.

In recent years, there has been significant progress and expansion in the development of evidence-based psychosocial treatments for substance abuse and dependence. A literature review was undertaken using the several electronic databases (PubMed, Cochrane Database of systemic reviews and specific journals, which pertain to psychosocial issues in addictive disorders and guidelines on this topic). Overall psychosocial interventions have been found to be effective. Some interventions, such as cognitive behavior therapy, motivational interviewing and relapse prevention, appear to be effective across many drugs of abuse. Psychological treatment is more effective when prescribed with substitute prescribing than when medication or psychological treatment is used alone, particularly for opiate users. The evidence base for psychological treatment needs to be expanded and should also include research on optimal combinations of psychological therapies and any particular matching effects, if any. Psychological interventions are an essential part of the treatment regimen and efforts should be made to integrate evidence-based interventions in all substance use disorder treatment programs.