Serum brain-derived neurotrophic factor level and its relation with cannabis use disorder and schizophrenia: A cross-sectional exploratory study in patients at a tertiary care hospital.

BACKGROUND: Brain-derived neurotrophic factor (BDNF) has considerable relevance in neural growth and differentiation. It has been evaluated as a biomarker for individuals with various psychiatric disorders such as substance-related disorders and psychotic disorders. OBJECTIVE: The present study explored differences in the levels of BDNF (in serum) among subjects using cannabis (with and without schizophrenia). METHODS: This cross-sectional observational study compared the serum BDNF level in male subjects aged 18-45 years. Four groups of 20 subjects each were included: individuals with tobacco use disorder only, patients having schizophrenia, patients with cannabis use disorder, and finally patients with comorbid cannabis use disorder and schizophrenia. RESULTS: The BDNF levels were found to be significantly different across the four groups. The BDNF levels in subjects with concurrent schizophrenia and cannabis use disorder were higher than each of the other three groups (cannabis use disorder, schizophrenia, and tobacco use disorder only). CONCLUSION: We find that BDNF may be higher when cannabis use disorder and schizophrenia co-occur, as compared to either of the conditions alone. The findings should be interpreted with caution due to the low sample size and potential confounders.

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.

An efficient method for simultaneous detection of Pheniramine, Pentazocine and cotinine in urine by Gas Chromatography in De-addiction program.

Background: Nonmedical use of prescription drugs for recreational purposes is a major health problem that raises high concerns for public health. Recently, several laboratory studies have reported the misuse of pentazocine, an agonist-antagonist opioid in combination with antihistamines in opioid addicts. Illicit self-administration of prescription drugs has been increasingly reported in India. Urinalysis as an adjunct to self-report plays a key role in providing additional information in the treatment of drug users. This paper aims to discuss a simple, convenient, and rapid capillary column gas-liquid chromatography method for simultaneous detection of pentazocine, pheniramine, and cotinine in urine. Methods: The sample was extracted with chloroform and isopropanol (3:1,v/v) and evaporated to dryness. After reconstitution with methanol, it was directly subjected to gas chromatography analysis. Method performance was evaluated and validated in terms of sensitivity, precision, the limit of detection (LOD), and the limit of quantification (LOQ). Findings: The linearity obtained was in the range of 50-1000 ng/ml with a correlation coefficient (r) above 0.999 for each drug. Good LOQ (50ng/ml) was obtained with each drug. Also, the developed method was effective in analyzing samples from patients with suspected abuse of these drugs. Conclusion: The technique was found to be simple, robust, sensitive, and precise in the simultaneous analysis of drugs (pentazocine, pheniramine, and cotinine). This method was proved to be useful and cost-effective in treating and monitoring patients seeking help for addiction in clinical settings.

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.

Influence of catechol-O-methyltransferase enzyme gene polymorphism on alcohol and tobacco consumption in North Indian treatment seeking population.

BACKGROUND: The co-occurrence of alcohol and tobacco dependence is frequently witnessed in treatment settings. It is a challenge for clinicians to treat such patients due to their powerful biological association. AIM: The study is aimed to assess the relationship of Catechol-O-methyltransferase (COMT) Val158Met polymorphism with substance intake among individuals who are dependent on both alcohol and tobacco. MATERIALS AND METHODS: A cross-sectional study involving patients coming to the outpatient department was planned. Brief information on their sociodemographic and substance use profile was recorded. Genotyping of COMT Val158Met was carried out using established polymerase chain reaction-restriction fragment length polymorphism method. The COMT genotyping was classified based on the presence or absence of Met allele using the dominant model. Descriptive statistics, Chi-square test, Mann-Whitney test, and Binary logistic regression analysis were performed to analyze the data. RESULTS: The study included 104 alcohol and nicotine co-dependent subjects. More than eighty percent of the participants were educated above secondary level, married, and employed. The allele frequencies of met and Val were found to be 0.23 and 0.77, respectively. Forty percent of the participants reported tobacco-related health problems. The odds of consuming alcohol and nicotine were four times high among Met allele carriers. While the Fagerström test for nicotine dependence and heaviness of smoking index scores were up to four and eight times higher among met allele (odds ratio 4.3 and 8.9, respectively). CONCLUSION: Patients carrying Met allele are reported to consume higher amounts of alcohol and tobacco and were likely to score high among measures of nicotine dependence. Thus met allele carriers needs additional attention for a successful treatment outcome.

Co-administration of nalbuphine attenuates the morphine-induced anxiety and dopaminergic alterations in morphine-withdrawn rats.

INTRODUCTION: The classical effects of exogenous opioids, such as morphine, are predominantly mediated through µ-opioid receptors. The chronic use of morphine induces anxiety-like behavior causing functional changes in the mesolimbic dopaminergic system. The mixed µ/κ-agonist, nalbuphine, used either as an analgesic or as an adjuvant with morphine, produces different and opposite effects. However, whether nalbuphine can be used to antagonize morphine-induced anxiety and dopaminergic alterations is not fully known. OBJECTIVE: This study aimed to compare acute and chronic effects of nalbuphine on morphine-induced anxiety and dopaminergic alterations in rats. METHODS: Male adult Wistar albino rats were made opioid-dependent by administering increasing doses of morphine (5-25 mg/kg; i.p.; b.i.d.). Withdrawal was induced by naloxone (1 mg/kg, i.p.), 4 h after the last morphine injection. Anxiety-like behavior was measured using Activity Monitor (Coulbourn Instruments, Inc. USA). Thereafter, the animals were sacrificed and the brain dissected out and the level of cAMP and the transcriptional and translational expression of TH was measured. Nalbuphine was co-administered with morphine, acutely and chronically, at various doses (0.1, 0.3, 1.0, 3.0 mg/kg, i.p.). RESULTS: Morphine-dependent rats showed a significant higher anxiety and cAMP levels and a significant decrease in the expression of TH. Co-administration of chronic doses of nalbuphine attenuates the higher anxiety, cAMP levels, and upregulates the TH expressions; however, the acute nalbuphine treatment does not attenuate the morphine-induced side effects. CONCLUSION: Therefore, nalbuphine might have an important role in attenuating the anxiety and the effects of the dopaminergic pathway and may have potential in the treatment of opioid addiction.

Brain-derived neurotrophic factor (BDNF) levels in first-episode schizophrenia and healthy controls: A comparative study.

BACKGROUND: Abnormalities in brain development and plasticity have been associated with the pathophysiology of schizophrenia. The role of brain-derived neurotrophic factor (BDNF) in schizophrenia is the recent area of interest because it regulates neurogenesis. The current study aimed to assess and compare serum BDNF levels between first-episode schizophrenia patients and healthy controls, and evaluate its correlation with the socio-demographic and clinical variables. METHODOLOGY: It was a cross-sectional comparative study for the assessment of serum BDNF levels between patients with first-episode schizophrenia (N=50) and healthy controls (N-50) conducted in the Department of Psychiatry at a tertiary care public hospital attached to a medical school in North India. Participants were assessed for the socio-demographic parameters, nicotine dependence, and clinical details using structured scales. Serum BDNF level estimated using the sandwich ELISA technique. The comparison between the groups was done by using a Student t-test or chi-square test. Spearman correlation was performed between mean BDNF scores and demographic or illness variables in both first-episode schizophrenia and healthy control groups. RESULTS: There was a significantly lower mean score of total serum BDNF levels in first-episode schizophrenia patients as compared to controls (8.44 ± 1.54 vs 10.44 ± 2.04; t = 5.52, p < 0.001; 95% CI = 1.28-2.71). The total FTND scores for smokeless tobacco use were negatively correlated to BDNF levels among healthy controls (r=-0.30, p=0.03) as well as in the first-episode schizophrenia group (r=-0.32, p= 0.04). None of the other illness-related variables were correlated to serum BDNF values in the first episode schizophrenia group. CONCLUSION: Individuals with first-episode schizophrenia have lower serum BDNF levels than healthy controls. The illness-related factors such as duration of untreated psychosis or psychopathology were not correlated with BDNF levels. Thus abnormal signaling of BDNF can lead to abnormal brain functioning which can make an individual more susceptible to schizophrenia.

Assessment of Subjective Sleep Problems in Men With Opioid Dependence Maintained on Buprenorphine.

OBJECTIVES: To assess the rates of sleep disturbances in male patients with opioid dependence maintained on buprenorphine and to assess the factors associated with sleep disturbances in this population. METHODS: Observational, cross-sectional study. Male patients with opioid dependence aged 18 years and older, and started on buprenorphine at least 6 months before were screened. Those with history of comorbid psychiatric illnesses (except sleep disorders), on any other substance in high-risk category (based on WHO-Alcohol Smoking Substance Involvement Screening Test (ASSIST)), or on any other psychotropic medications (in addition to OAT with buprenorphine) were excluded. Sleep was assessed using the Pittsburgh Sleep Quality Index (PSQI), Sleep-50, and Epworth Sleepiness Scale (ESS). Each participant was interviewed in a single session lasting 60 minutes. RESULTS: One hundred six participants were included. Their mean age was 41.1 (SD 14.3) years. The participants had been on OAT with buprenorphine for a median duration of 60 months (IQR 17-120), with excellent adherence rate in past 1 month. The mean current dose of buprenorphine was 10.2 (SD 3.8) mg per day. The mean subjective total sleep time was 403.5 minutes (SD 94.8) and the median sleep latency was 35 minutes (IQR 18.8-62.5). The mean PSQI score was 6.6 (SD 3.4). Nearly 63% (n = 67) participants had PSQI scores more than 5 (PSQI > 5) suggesting sleep problems. Sociodemographic, substance use, and treatment variables were compared between participants who scored more than 5 and those who scored less than 5 on PSQI. No significant difference was found between the 2 groups. CONCLUSIONS: Substantial proportion of male patients with opioid dependence maintained on buprenorphine have sleep problems. The sleep problems in buprenorphine-maintained patients seem to be independent of substance use and treatment-related attributes.

Which Criteria to Use to Identify Metabolic Syndrome among Patients with Addictive Disorders?: Observations among Patients with Alcohol and Opioid Dependence Syndrome.

In spite of various psychoactive substances (including tobacco, alcohol, and opioids) being closely associated with development of metabolic syndrome (MS), little research exists on the prevalence of MS among persons with addictive disorders. The criteria used to diagnose MS varied across these studies, and part of the variation in the prevalence rate (5.1%-30.6%) could be attributable to this fact. The current study aimed to assess the prevalence of MS in patients with alcohol dependence syndrome (ADS) and opioid dependence syndrome (ODS) using revised National Cholesterol Education Programme Adult Treatment Panel (NCEP ATP-III) criteria and International Diabetes Federation (IDF) criteria. We tried to assess the impact of the choice of the diagnostic criteria on the prevalence rate of MS in the persons with ADS and ODS. This was a cross-sectional observational study. Semi-structured pro forma was used to collect information on the sociodemographic profile and clinical profile. Anthropometric measurements included waist circumference, height, weight, and body mass index (BMI). The systolic and diastolic blood pressure, fasting blood sugar (FBS), serum triglycerides, and serum high-density lipoprotein were measured. Patients were diagnosed as having MS by using revised NCEP ATP-III and IDF criteria. Statistical analysis was done by Chi-square (Fischer's exact test), independent sample Student's t-test, and Cohen's kappa. Among the individuals with ADS, the prevalence of MS was found to be 20.8% and 9.9% according to revised NCEP ATP III criteria and IDF criteria, respectively. Among individuals with ODS, the prevalence of MS was found to be 20.3% and 5.1% according to revised NCEP ATP III criteria IDF criteria, respectively. While there was a good degree of concordance between IDF and modified NCEP-ATP III criteria for MS for ADS (n = 256) (κ = 0.649, P < 0.001), the concordance was only fair for ODS (κ = 0.333, P < 0.001). The findings of our study thereby support the recommendation that revised NCEP ATP-III criteria is better choice than IDF criteria for identification of MS in individuals having addictive disorders, especially opioid dependence.

Evaluation of Dried Urine Spot Method to Screen Cotinine among Tobacco Dependents: An Exploratory Study.

BACKGROUND AND OBJECTIVES: Assessment of cotinine, a metabolite of nicotine in body fluids, is an important approach for validating the self-report among tobacco users. Adaptation of assays on dried urine spots (DUSs) has advantages of ease of collection, transportation, minimal invasiveness, and requirement of small volume. The aim of the present study was to develop an efficient method for testing cotinine in DUSs and evaluating its clinical applicability. METHODS: This involved optimization of conditions for detection, recovery, and stability of cotinine from dried urine, spotted on filter paper. Enzyme-linked immunosorbent assay was used for screening, whereas confirmation was done by gas chromatography. For clinical applicability, urine samples of tobacco users were tested. RESULTS AND INTERPRETATION: Water was found to be a suitable extracting solvent as compared to carbonate-bicarbonate buffer (pH 9.2) and saline. Screening was achieved by two punches taken from a 20 µl (diameter 1.3 cm) spotted urine samples, and confirmation was achieved by five complete circles each of 20 µl sample volume. The recovery was found to be 97% in water. Limit of detection for the method was found to be 100 ng/ml. No signs of significant degradation were found under all storage conditions. All the urine samples of tobacco users were found to be positive by a conventional method as well as DUSs, and the method proved to be efficient. CONCLUSIONS: DUS samples are a useful alternative for biological monitoring of recent nicotine use, especially in developing countries where sample logistics could be an important concern.

Association of ankyrin repeats & kinase domain containing 1 (ANKK1) gene polymorphism with co-morbid alcohol & nicotine dependence: A pilot study from a tertiary care treatment centre in north India.

BACKGROUND & OBJECTIVES: The frequently encountered co-morbidity of alcohol dependence (AD) with nicotine dependence (ND) increases the risk for various diseases. Ankyrin repeats and kinase domain containing 1 (ANKK1) gene polymorphism is reported to be associated with both ND and AD. This study was undertaken to investigate the possible association of alcohol and tobacco use variables with ANKK1 polymorphism in co-morbid alcohol- and nicotine-dependent treatment seekers visiting a tertiary care centre in north India. METHODS: Seventy nine male participants (18-65 yr old) fulfilling diagnostic criteria for ND and AD were included in the study. The socio-demographic data, along with alcohol and tobacco use profile, was recorded and ANKK1 profiling was carried out. Both the allele groups, A1 and A2, were compared with respect to demographic and substance dependence profile. Univariate binary logistic regression analysis was performed to determine the risk of high nicotine and alcohol consumption with genotype. RESULTS: The A1 carrier group (n=33) reported a significantly higher amount of alcohol and tobacco consumed per day. The scores on parameters of ND were found to be significantly higher in this group. The logistic regression analysis revealed that participants with A1 genotype were 2.5 times more likely to report higher amount of alcohol and nicotine consumption than A2 carriers. INTERPRETATION & CONCLUSIONS: The study provides an indication for the association of ANKK1 polymorphism in the form of higher substance consumption among alcohol dependent smokers, who are A1 carriers and thus may require higher attention of the treatment provider.

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.

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.

Profile of nicotine use among alcohol dependent patients visiting a tertiary care center in north India.

BACKGROUND: Use of tobacco among alcohol dependent population is quite frequent. This co-morbidity increases the risk for various diseases. Understanding the pattern of tobacco use with co-morbid alcohol use may help in planning appropriate prevention/treatment strategies. The study aimed at examining the profile and pattern of nicotine use among alcohol dependent patients visiting a tertiary care treatment center in North India. MATERIALS AND METHODS: Male patients fulfilling diagnostics and statistical manual of mental disorder fourth edition, criteria for nicotine and alcohol diagnostics and statistical dependence, attending the out-patient department of the tertiary care treatment center were recruited after obtaining informed consent. The socio-demographic profile, drug use history, nicotine associated health problems and general health problem were recorded. Motivation to stop tobacco use was assessed qualitatively using the direct questions about their interest and intentions to quit. RESULTS: A total of 150 subjects were included in the study. The mean age of the study sample was 37.6 ± 10.44 years. Tobacco was reported as the gateway drug in 90% of the cases. Exclusive bidi use reported in 42% of the subjects. Mean duration of bidi and co-morbid alcohol use was higher than cigarette or smokeless tobacco use. Self-reported health problems associated with nicotine use and general health was reported by 41% and 39% of the subjects. Unsuccessful past quit attempts was present in 85% cases. More than 90% of subjects remained interested in quitting the tobacco use. An increased liver enzyme (aspartate transaminase, alanine transaminase and gamma-glutamyl transferase) were observed in 43, 32 and 47% of the cases. CONCLUSION: The results suggest the nicotine and alcohol dependent patients represent a separate population requiring higher attention from the treating physician.

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.

Comparison of efficacy between buprenorphine and tramadol in the detoxification of opioid (heroin)-dependent subjects.

AIM/BACKGROUND: Tramadol is a synthetic opiate and a centrally acting weak m-opioid receptor agonist. The potential advantages of tramadol include ease of administration, low abuse potential, and being nonscheduled. This study compared tramadol and buprenorphine for controlling withdrawal symptoms in patients with opioid dependence syndrome. METHODS: Consenting male subjects between 20 and 45 years of age who fulfilled the ICD-10-DCR criteria for opiate dependence syndrome were randomly assigned in a double-blind, double-dummy placebo-controlled trial for detoxification. Those with multiple drug dependence, abnormal cardiac, renal and hepatic functions, psychosis, or organic mental illness were excluded. Assessments included Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), Visual Analog Scale (VAS), and Side Effect Check List. Subjects were evaluated daily and study duration was 10 days. RESULTS: Sixty two subjects were enrolled. The mean SOWS and OOWS and VAS were significantly lower in the buprenorphine group on second and third day of detoxification as compared to the tramadol group. Although the retention rate was higher for buprenorphine group throughout the study, when compared with tramadol the difference was not significant on any day. Three subjects in the tramadol group had seizures. CONCLUSIONS: Tramadol was found to have limited detoxification efficacy in moderate to severe opioid withdrawal and substantial risk of seizures as compared to buprenorphine. Further studies are warranted to examine its efficacy in mild opioid withdrawal symptoms and its potential use in outpatient settings where its administration advantages may be valuable.

A receiver operated curve-based evaluation of change in sensitivity and specificity of cotinine urinalysis for detecting active tobacco use.

BACKGROUND: Tobacco use has been associated with various carcinomas including lung, esophagus, larynx, mouth, throat, kidney, bladder, pancreas, stomach, and cervix. Biomarkers such as concentration of cotinine in the blood, urine, or saliva have been used as objective measures to distinguish nonusers and users of tobacco products. A change in the cut-off value of urinary cotinine to detect active tobacco use is associated with a change in sensitivity and sensitivity of detection. AIM: The current study aimed at assessing the impact of using different cut-off thresholds of urinary cotinine on sensitivity and specificity of detection of smoking and smokeless tobacco product use among psychiatric patients. SETTINGS AND DESIGN: All the male subjects attending the psychiatry out-patient department of the tertiary care multispecialty teaching hospital constituted the sample frame for the current study in a cross-sectionally. MATERIALS AND METHODS: Quantitative urinary cotinine assay was done by using ELISA kits of Calbiotech. Inc., USA. We used the receiver operating characteristic (ROC) curve to assess the sensitivity and specificity of various cut-off values of urinary cotinine to identify active smokers and users of smokeless tobacco products. RESULTS: ROC analysis of urinary cotinine levels in detection of self-reported smoking provided the area under curve (AUC) of 0.434. Similarly, the ROC analysis of urinary cotinine levels in detection of self-reported smoking revealed AUC of 0.44. The highest sensitivity and specificity of 100% for smoking were detected at the urinary cut-off value greater than or equal to 2.47 ng/ml. CONCLUSIONS: The choice of cut-off value of urinary cotinine used to distinguish nonusers form active users of tobacco products impacts the sensitivity as well as specificity of detection.

Pharmacological intervention of nicotine dependence.

Nicotine dependence is a major cause of mortality and morbidity all over the world. Various medications have been tried to treat nicotine dependence including nicotine replacement therapy, bupropion, and varenicline. A newer venture to nicotine dependence treatment is a nicotine vaccine which is yet to get footsteps in common practice. The present review assimilates various pharmacotherapeutic measures to address nicotine dependence. However, it is to be noted that psychological interventions, when combined with pharmacotherapy, offer the greatest benefits to the patients.