Alcohol Detoxification Treatment Research Articles

Predicting alcohol relapse post-detoxification: The role of cognitive impairments in alcohol use disorder patients.

Studies on early abstinence suggest that cognitive function is significantly reduced in the first year of abstinence, which raises the question of whether it is relevant to early relapse in patients with substance use disorders. This study investigates the extent to which impairments in executive function and memory predict alcohol relapse in patients with alcohol use disorder (AUD). Understanding these relationships is crucial for improving therapeutic approaches to prevent relapse in patients with AUD. We selected 116 adult patients (79 male and 37 female) diagnosed with AUD based on DSM-5 criteria, all of whom were undergoing alcohol detoxification treatment. A comprehensive array of neuropsychological tests was administered to assess global cognition, memory, and executive functions. Patients' alcohol use was monitored monthly during a 6-month follow-up period. Logistic regression and Cox regression were used to explore the relationship between cognitive function and the likelihood of alcohol relapse. Impairments in global cognition, semantic and phonemic fluency, cognitive flexibility, and learning ability during detoxification were significant predictors of relapse in AUD patients, showing similar predictive values at both 3 and 6 months post-treatment. An abnormal Montreal Cognitive Assessment (MoCA) score increased the risk of relapse by 123% (HR: 2.227), and impairments in both semantic and phonemic fluency each increased the risk by 142% (HR: 2.423). Additionally, abnormal performance on the MoCA, Trail Making Test Part B (TMT-B), and California Verbal Learning Test (CVLT) was associated with a higher number of drinking days at 3 months (IRR: 3.764; IRR: 2.237; IRR: 2.738, respectively) and abnormal MoCA and TMT-B scores at 6 months (IRR: 2.451; IRR: 1.859, respectively). The MoCA test is a valuable tool for predicting relapse risk in AUD patients undergoing detoxification treatment, with similar predictive value for relapse at 3 or 6 months. Learning ability needs to be assessed and their impairments considered in the treatment of AUD patients.Future research should explore strategies for managing patients with impairments in memory and learning ability to enhance treatment effectiveness and prevent relapse.

Ketogenic diet reduces a neurobiological craving signature in inpatients with alcohol use disorder.

Increasing evidence suggests that a ketogenic (high-fat, low-carbohydrate) diet (KD) intervention reduces alcohol withdrawal severity and alcohol craving in individuals with alcohol use disorder (AUD) by shifting brain energetics from glucose to ketones. We hypothesized that the KD would reduce a neurobiological craving signature when individuals undergoing alcohol detoxification treatment were exposed to alcohol cues. We performed a secondary analysis of functional magnetic resonance data of 33 adults with an AUD who were randomized to a KD (n = 19) or a standard American diet (SA; n = 14) and underwent 3 weeks of inpatient alcohol detoxification treatment. Once per week, participants performed an alcohol cue-reactivity paradigm with functional magnetic resonance imaging. We extracted brain responses to food and alcohol cues and quantified the degree to which each set of brain images shared a pattern of activation with a recently established 'Neurobiological Craving Signature' (NCS). We then performed a group-by-time repeated measures ANOVA to test for differences in craving signature expression between the dietary groups over the three-week treatment period. We also correlated these expression patterns with self-reported wanting ratings for alcohol cues. For alcohol relative to food cues, there was a main effect of group, such that the KD group showed lower NCS expression across all 3 weeks of treatment. The main effect of time and the group-by-time interaction were not significant. Self-reported wanting for alcohol cues reduced with KD compared to SA but did not correlate with the NCS score. A ketogenic diet reduces self-reported alcohol wanting, and induced lower NCS to alcohol cues during inpatient treatment for AUD. However, in the KD group alcohol wanting continued to decrease across the 3 weeks of abstinence while the NCS scores remained stable, suggesting that this cue-induced NCS may not fully capture ongoing, non-cue-induced alcohol desire.

Further Evidence of Relationship Between Thiamine Blood Level and Cognition in Chronic Alcohol-Dependent Adults: Prospective Pilot Study of an Inpatient Detoxification with Oral Supplementation Protocol.

The relationship between thiamine blood level (TBL) and cognition remains uncertain including amongst alcohol-dependent persons (ADP) AIM: To evaluate this relationship during protocol-driven inpatient alcohol detoxification treatment including thiamine supplementation (AD+Th) METHODS: Prospective 3-week study with 100 consecutively admitted detoxification-seeking ADP (47.7±11 years-old, 21% females) without superseding comorbidities requiring treatment. TBL and Montreal Cognitive Assessment (MoCA) were measured at admission (t1, pre-AD+Th) and discharge (t3, post-AD+Th). Frontal Assessment Battery (FAB) was performed at t1. AD+Th included abstinence, pharmacological alcohol withdrawal syndrome treatment and oral thiamine supplementation (200 mg/day for 14 days). Regression and mediation analyses assessed TBL-cognition relationships. We found no cases of Wernicke Encephalopathy (WE) and only one case of thiamine deficiency. Both MoCA and TBL significantly improved across AD+Th (with medium-to-large effect sizes). At t1, TBL significantly predicted MoCA and FAB sum scores (medium effect sizes; extreme and very strong evidence, respectively). The clear TBL-MoCA association disappeared at t3. In multivariate regression and mediation analyses exploring key influential factors of cognition (identified by LASSO regression), the TBL-MoCA interactions did not relevantly change at t1 and t3. Age, serum transaminases, vitamin D levels, drinking-years and depression score weakly modified the relationship. TBL was a robust predictor of pre-detoxification cognitive impairment, and both TBL and cognition improved significantly during AD+Th (including abstinence) in our ADP population, supporting routine thiamine supplementation for ADP, even those at low WE-risk. TBL-cognition relationship was minimally confounded by age, alcohol-toxicity proxies, mood, and vitamin D levels. https://osf.io/b54eh/.

The effect of intranasal oxytocin on processing emotional stimuli during alcohol withdrawal: A randomized placebo-controlled double-blind clinical trial

Alcohol dependence is associated with difficulties in processing emotional stimuli, which can lead to interpersonal problems. The neuropeptide oxytocin has been shown to modulate the processing of emotional stimuli, however, oxytocin treatment has not yet been examined in patients with withdrawal symptoms during alcohol detoxification. The aim of the present study was to investigate the effect of oxytocin on the reading the mind in the eyes test (RMET), which indexes theory of mind ability, during a three-day period of alcohol detoxification at an addiction treatment centre in Norway. We performed a randomized, double-blind, placebo-controlled trial in 39 patients fulfilling criteria for ICD-10 diagnosis of alcohol dependence admitted for alcohol detoxification and withdrawal treatment. Participants were randomized to receive either intranasal oxytocin (24 IU) or placebo, twice daily for three days. We evaluated RMET performance on day 2 and day 3 of detoxification and differences in RMET scores between day 2 and day 3 of detoxification. Frequentist and Bayesian statistical inference suggested that oxytocin administration during alcohol withdrawal in alcohol-dependent patients did not improve RMET performance. However, exploratory analyses provided preliminary evidence that oxytocin might improve performance on the RMET negative emotion subscale (uncorrected p value = 0.038), and that oxytocin treatment might show the most promise for those with high levels of alcohol consumption (i.e., ≥20 alcohol units per day; uncorrected p value = 0.023). Moreover, alcohol consumption levels significantly predicted RMET performance on day 2, but not on day 3, of withdrawal.

Health outcomes among detoxification patients: The role of chronic pain.

Understanding associations between chronic pain and health outcomes among detoxification patients may help improve treatment outcomes and abstinence rates. Exercise is a modifiable lifestyle factor that may reduce the effect of pain on outcomes in this population. The current study examined whether baseline pain, exercise, and their interaction were associated with psychiatric and medical severity, and abstinence self-efficacy, over six months following detoxification. Participants were veteran patients in alcohol or opioid detoxification treatment (N=298) who were followed for six months (91.1%). Psychiatric severity and abstinence self-efficacy improved over the six months after detoxification; medical severity was stable. More intense pain at baseline was associated with poorer psychiatric and medical outcomes during the post-detoxification period. Regular exercise at baseline was associated with less psychiatric severity and more abstinence self-efficacy during the post-detoxification period. A significant pain by exercise interaction at baseline indicated that regular exercise was associated with more abstinence self-efficacy during the post-detoxification period only among participants with less intense pain. Pain by exercise interactions was not significant for the outcomes of psychiatric and medical severity. Among detoxification patients, exercise may be beneficial in improving outcomes among those with less intense pain.

COVID-19 Social Restrictions: An Opportunity to Re-visit the Concept of Harm Reduction in the Treatment of Alcohol Dependence. A Position Paper.

The COVID-19 pandemic is presenting significant challenges for health and social care systems globally. The implementation of unprecedented public health measures, alongside the augmentation of the treatment capacity for those severely affected by COVID-19, are compromising and limiting the delivery of essential care to people with severe substance use problems and, in some cases, widening extreme social inequities such as poverty and homelessness. This global pandemic is severely challenging current working practices. However, these challenges can provide a unique opportunity for a flexible and innovative learning approach, bringing certain interventions into the spotlight. Harm reduction responses are well-established evidenced approaches in the management of opioid dependence but not so well-known or implemented in relation to alcohol use disorders. In this position paper, we explore the potential for expanding harm reduction approaches during the COVID-19 crisis and beyond as part of substance use treatment services. We will examine alcohol use and related vulnerabilities during COVID-19, the impact of COVID-19 on substance use services, and the potential philosophical shift in orientation to harm reduction and outline a range of alcohol harm reduction approaches. We discuss relevant aspects of the Structured Preparation for Alcohol Detoxification (SPADe) treatment model, and Managed Alcohol Programs (MAPs), as part of a continuum of harm reduction and abstinence orientated treatment for alcohol use disorders. In conclusion, while COVID-19 has dramatically reduced and limited services, the pandemic has propelled the importance of alcohol harm reduction and created new opportunities for implementation of harm reduction philosophy and approaches, including programs that incorporate the provision of alcohol as medicine as part of the substance use treatment continuum.

Brain-derived neurotrophic factor and glutathione peroxidase as state biomarkers in alcohol use disorder patients undergoing detoxification.

The pathophysiology of alcohol use disorder (AUD) is not totally clear. The aim of this study was to investigate the serum levels of brain-derived neurotrophic factor (BDNF) and oxidative stress markers in AUD patients during alcohol detoxification. Evaluation of changes in BDNF, glutathione peroxidase (GPX), catalase, superoxide dismutase, thiobarbituric acid reactive substances, 8-hydroxy 2’-deoxyguanosine, PCC and S100B were carried out.14 AUD inpatients and 20 healthy control subjects were recruited for this study. The serum BDNF, S100B and oxidative stress markers were measured with assay kits.Serum levels of catalase, GPX, PCC and 8-hydroxy 2’-deoxyguanosine were significantly higher in the AUD group subjects than in the controls (P < .05). However, BDNF levels were lower in the AUD group than in the controls (P < .05). After alcohol detoxification treatment, the GPX levels in the AUD group dropped (P < .05) and the BDNF levels rose (P < .05).The results suggest that serum BDNF and GPX levels might be state biomarkers for AUD patients undergoing alcohol detoxification.

Effectiveness of symptom-triggered regimen versus fixed-dosage regimen of benzodiazepine treatment for alcohol detoxification: a systematic review protocol.

The objective of this review is to evaluate the effectiveness of a symptom-triggered regimen versus a fixed-dosage regimen of benzodiazepine treatment for alcohol detoxification. Patients with alcohol use disorder who suddenly decrease their alcohol consumption or abstain completely may experience alcohol withdrawal syndrome. Adequate treatment of detoxification can relieve the patient's distress, prevent the development of more serious symptoms and forestall collective effects that might worsen future withdrawals. The review will consider studies that include people with alcohol withdrawal syndrome who are taking benzodiazepine treatment in an inpatient setting. Studies of people with alcohol withdrawal syndrome who are under the age of 18 will be excluded. This review will exclude studies of people with alcohol withdrawal syndrome who are non-verbal (e.g. stupor due to head injury) or have a history of seizure. Studies published in English will be included. An initial limited search of MEDLINE and CINAHL was undertaken to identify articles. The text words contained in the titles and abstracts, and index terms were used to develop a full search strategy. The search strategy, including all identified keywords and index terms, will be adapted for each included information source. Studies will be pooled for statistical meta-analysis. Effect sizes will be expressed as odds ratios (for categorical data) or weighted mean differences (for continuous data), and their 95% confidence intervals will be calculated for analysis. The heterogeneity will be assessed using the I test and chi-squared test. PROSPERO CRD42018115777.

Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial

BackgroundIn a pilot study, intranasal oxytocin was demonstrated to reduce the benzodiazepine dose needed to relieve withdrawal symptoms during alcohol detoxification. The aim of the present study was to compare the effect of oxytocin and placebo during a three-day period of alcohol detoxification at an addiction treatment center in Norway. MethodsRandomized, double-blind, placebo-controlled trial with 40 patients fulfilling criteria for ICD-10 diagnosis of alcohol dependence (F10.2), admitted for alcohol detoxification and withdrawal treatment. The benzodiazepine oxazepam was given as symptom-triggered treatment based on the scores of the Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) scale. Participants were randomized to receive either intranasal oxytocin (24 IU twice daily) or placebo. Primary outcome: Oxazepam dose required to complete a three-day course of detoxification. Secondary outcomes: Scores of the CIWA-Ar, the 10-item Hopkins Symptom Check List (HSCL-10), and self-reported total number of hours of sleep. ResultsThe mean total oxazepam dose (± standard deviation) was 56.8 ± 72.8 mg in the oxytocin group and 79.0 ± 122.9 in the placebo group (p = 0.490; difference -22.3 mg; 95% confidence interval (CI) -86.9 to +42.4 mg). The findings were inconclusive as to whether a difference in the CIWA-Ar score (5.94 ± 3.86 vs. 6.48 ± 3.92; p = 0.665) or in any of the other secondary outcomes was present. No serious adverse events were reported. ConclusionCompared to placebo, intranasal oxytocin did not significantly reduce the oxazepam dose needed to complete a 3-day course of alcohol detoxification and withdrawal treatment.

Community alcohol detoxification in primary care services

Jeff Fernandez explains how primary care services are vital to providing cost-effective and successful alcohol detoxification treatment in the community, and they should not be reduced as a result of cuts to healthcare funding The good provision of alcohol and drug services need to be protected despite budget cuts and the continual redesign of primary care services. This article will examine the alcohol detoxifications completed in one alcohol and drug service over a 2-year period and asserts that what is effective should be retained in any service redesign. An in-depth case study of a typical patient of the service will be presented to illustrate in detail the positive effects that detoxification can have. This article suggests that this valuable work should not be lost or reduced as a result of funding cuts to the health service.

Thirty- Versus Ten-Day Diazepam Treatment for Alcohol Detoxification and a Comparison of Drinking Patterns, Craving, and Anxiety for up to 12 Weeks: A "Proof-of-Concept" Open-Label Randomized Controlled Trial.

The aim of this study was to evaluate whether a prolonged detoxification treatment could decrease the relapse rate at 3 months after alcohol cessation in alcohol-dependent individuals through decreasing the levels of postdetoxification craving and anxiety. Twenty-six adult patients with alcohol dependence (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) who began an outpatient alcohol cessation program with an initial drinking goal of abstinence were enrolled in a 3-month, parallel, randomized (1:1 ratio), controlled, open-label, pilot trial. Participants were randomized to receive a detoxification treatment of diazepam with a duration of 30 (n = 12) or 10 days (n = 14). All participants received BRENDA-based psychotherapy during follow-up. No significant between-group difference in relapse to any drinking was found at 3 months (P = 0.20). However, relapse to any heavy drinking at 3 months and regular drinking or heavy drinking during follow-up were significantly lower in the 30-day diazepam group (P = 0.009, P = 0.049, and P = 0.004, respectively). These differences were corroborated by significant differences in the alcohol-specific biological marker carbohydrate deficient transferrin at 3 months. Participants in the 30-day diazepam group also displayed significantly lower scores for alcohol craving (P = 0.007), self-reported anxiety (P = 0.024), and clinician-assessed anxiety (P = 0.002) throughout the follow-up. No serious adverse event was reported during the study. This study provides an evidence-based rationale for a double-blind, randomized, placebo-controlled trial to confirm the efficacy of such a procedure on short-term and mid-/long-term drinking outcomes after alcohol cessation in alcohol-dependent individuals.

Automatic avoidance tendencies for alcohol cues predict drinking after detoxification treatment in alcohol dependence.

Alcohol dependence is characterized by conflict between approach and avoidance motivational orientations for alcohol that operate in automatic and controlled processes. This article describes the first study to investigate the predictive validity of these motivational orientations for relapse to drinking after discharge from alcohol detoxification treatment in alcohol-dependent patients. One hundred twenty alcohol-dependent patients who were nearing the end of inpatient detoxification treatment completed measures of self-reported (Approach and Avoidance of Alcohol Questionnaire; AAAQ) and automatic (modified Stimulus-Response Compatibility task) approach and avoidance motivational orientations for alcohol. Their drinking behavior was assessed via telephone follow-ups at 2, 4, and 6 months after discharge from treatment. Results indicated that, after controlling for the severity of alcohol dependence, strong automatic avoidance tendencies for alcohol cues were predictive of higher percentage of heavy drinking days (PHDD) at 4-month (β = 0.22, 95% CI [0.07, 0.43]) and 6-month (β = 0.22, 95% CI [0.01, 0.42]) follow-ups. We failed to replicate previous demonstrations of the predictive validity of approach subscales of the AAAQ for relapse to drinking, and there were no significant predictors of PHDD at 2-month follow-up. In conclusion, strong automatic avoidance tendencies predicted relapse to drinking after inpatient detoxification treatment, but automatic approach tendencies and self-reported approach and avoidance tendencies were not predictive in this study. Our results extend previous findings and help to resolve ambiguities with earlier studies that investigated the roles of automatic and controlled cognitive processes in recovery from alcohol dependence.

Investigation of pre-delirium and delirium in patients with alcohol withdraw

AbstractIntroduction: Alcohol withdraw syndrome (AWS) and delirium tremens (DTs) are part of the clinical picture of alcohol dependence (AD). The mechanisms by which these conditions develop are not entirely understood, but there are data suggesting that several factors are largely responsible for the emergence of the AWS and DTs. According to some authors, with the prolongation of the AD and increasing tolerance, the AWS aggravates, somatic and neurovegetative manifestations worsen. Russian authors accept that the degree of clinical manifestations depends on the individual characteristics of the response to ethanol. Materials and methods: The present work is a systematic study of 28 alcohol-dependent patients that developed clinical signs and symptoms of pre-delirium and delirium during alcohol detoxification treatment. Results: The relationship between sex, age, type and duration for abuse, type of alcoholic beverage, and the clinical picture has been analyzed and discussed as well as the criteria for t...

Changes in Nutrition-Related Behaviors in Alcohol-Dependent Patients After Outpatient Detoxification: The Role of Chocolate

ABSTRACTBackground: Previous studies have reported changes in nutrition-related behaviors in alcohol-dependent patients after alcohol detoxification, but prospective studies assessing the effects of these changes on maintaining abstinence are lacking. Objectives: To assess changes in craving and consumption of chocolate and other sweets over time up to six months after outpatient alcohol detoxification treatment and to detect differences in abstinent versus nonabstinent patients. Methods: One hundred and fifty alcohol-dependent patients were included in this prospective observational study. Participants completed self-report questionnaires on nutrition-related behaviors and craving before detoxification treatment (baseline, t1), one week (t2), one month (t3), and six months later (t4). Results: Significant changes in craving for and consumption of chocolate as well as in craving for other sweets were observed over time. Increases were most prominent within the first month. Patients who remained abstinent until t3 consumed three times more chocolate than nonabstainers. One quarter of the patients switched from being rare (t1) to frequent (t3) chocolate eaters, and 84% of these remained abstinent until t3. No significant correlations were found between craving for alcohol and craving for or consumption of chocolate or other sweets. Conclusions/Importance: In the first month after outpatient alcohol detoxification treatment, significant changes in nutrition-related behaviors were observed. These changes were not associated with alcohol craving. For a subgroup, increasing the frequency of chocolate consumption might be a temporary protective factor with respect to alcohol relapse.

Alcohol abuse and cigarette smoking are associated with global DNA hypermethylation: Results from the German Investigation on Neurobiology in Alcoholism (GINA)

Recent studies have shown that smoking and alcoholism may be associated with altered DNA methylation and that alcohol consumption might induce changes in DNA methylation by altering homocysteine metabolism. In this monocenter study, we included 363 consecutive patients referred for hospitalization for alcohol detoxification treatment. Blood samples were obtained on treatment days 1, 3, and 7 for measurement of global DNA methylation in leukocytes by liquid chromatography tandem mass spectrometry. Genomic DNA was used for genotyping the following seven genetic variants of homocysteine metabolism: cystathionine beta-synthase (CBS) c.844_855ins68, dihydrofolate-reductase (DHFR) c.594 + 59del19bp, methylenetetrahydrofolate-reductase (MTHFR) c.677C > T and c.1298A > C, methyltetrahydrofolate-transferase (MTR) c.2756A > G, reduced folate carrier 1 (RFC1) c.80G > A, and transcobalamin 2 c.776C > G. Multivariate linear regression showed a positive correlation of global DNA methylation with alcohol consumption and smoking on day 1 of hospitalization. DNA methylation was not correlated with homocysteine or vitamin plasma levels, nor with the tested genetic variants of homocysteine metabolism. This suggests a direct effect of alcohol consumption and smoking on DNA methylation, which is not mediated by effects of alcohol on homocysteine metabolism.

Self-reported medical co-morbidity among 400 substance using patients at an addiction unit in India

Background and aims: Medical illnesses appear to be more common in substance users than non-users. However, research on medical co-morbidities with substance use disorders is sparse from developing countries. This study aimed to study the occurrence of medical co-morbidites in a sample of patients in India.Methods: This cross-sectional observational study was carried out at the de-addiction centre in northern India which caters to patients seeking treatment for alcohol detoxification and opioid use disorders and smoking cessation. Consecutive newly registered patients with substance use disorder were recruited and information was gathered using a structured questionnaire. Charlson Co-morbidity Index (CCI) was calculated.Results: In total, 406 consecutive participants were enrolled. Of the total, 215 patients (53.0% of the sample) had co-morbid medical disorders. The organ systems affected in descending order of frequency was gastrointestinal (24.9%), neurological (12.1%), cardiovascular (6.9%), infections (5.4%), orthopaedic (4.9%), pulmonary (4.7%), endocrine (3.7%), ophthalmic (2.4%), dermatological (1.9%), renal (1.7%), ENT (1.5%) and others (2.5%). Logistic regression revealed age, alcohol use disorder and nuclear family type as independent predictors of a medical disorder.Conclusions: Medical disorders frequently co-exist with substance use disorders, and need to be systematically evaluated and addressed for better patient management.

Biochemical Predictors of Delirium Tremens in Patients in Alcohol Withdrawal

Aims: To study whether routine blood parameters in patients with alcohol syndrome predict the risk of developing delirium tremens. Methods: Biochemical parameters were collected and analysed in 212 patients attending a psychiatry department for inpatient alcohol detoxification treatment. Results: Differences between those who did, and did not, develop delirium were observed in baseline platelet count (131 ± 53 versus 270 ± 83 × 109/l, t = −10.013, P 75 U/l, and total WBC count <7 × 109/l, although not significant as independent risk factors, showed high specificity and predictive value in conjunction with low platelet count and/or previous history of delirium tremens. A normal baseline platelet count nearly rules out development of delirium tremens in patients with alcohol withdrawal in this population.

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Ibogaine related sudden death: A case report

Ibogaine is a naturally occurring alkaloid derived from the roots of the rain forest shrub Tabernanthe iboga. Deaths have occurred temporarily related to the use of ibogaine. However, although not licensed as therapeutic drug, and despite evidence that ibogaine may disturb the rhythm of the heart, this alkaloid is currently used as an anti-addiction drug in alternative medicine for detoxification purposes. We report the case of a man who died suddenly 12–24 h after ibogaine use for alcohol detoxification treatment. In the autopsy liver cirrhosis and heavy fatty infiltration was found. The concentration of ibogaine was 2 mg/l. The potential risks of ibogaine use, especially for persons with pathological medical background, are discussed.

Topiramate treatment for alcoholic outpatients recently receiving residential treatment programs: A 12-week, randomized, placebo-controlled trial

BackgroundInitiation of a relapse prevention medication is crucial at the end of alcohol detoxification. This study aimed to examine the efficacy and safety of topiramate for alcoholism in patients receiving a residential treatment program of alcohol detoxification and post-acute treatment. MethodsThis was a 12-week, randomized, double-blind, placebo-controlled trial of topiramate for alcoholism in patients receiving a residential treatment program. Individuals with DSM-IV alcohol dependence with minimal withdrawal were enrolled. Participants were randomly assigned to receive either 100–300mg/day of topiramate or placebo. Primary outcomes were given as percentages of heavy drinking days and time to first day of heavy drinking. Other drinking outcomes, craving, and health-related quality of life were evaluated. ResultsA total of 106 participants were randomized to receive topiramate (n=53) or placebo (n=53). Twenty-eight participants of the topiramate group (52.8%) and 25 participants of the placebo group (47.2%) completed the study. Averaged over the trial period, there was no significant difference between groups on the mean percentages of heavy drinking days [1.96 (−1.62 to 5.54), p=.28]. Log rank survival analysis found no difference of time to first day of heavy drinking between topiramate and placebo groups (61.8 vs. 57.5 days, respectively; χ2=0.61, d.f.=1, p=.81). Other secondary outcomes were not significantly different between groups. ConclusionsBy using a conservative model for data analysis, we could not detect the effectiveness of topiramate in this particular population. As the sensitivity analysis showed a trend of its benefit, further studies in larger sample sizes are still warranted.