ContextHypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol's reinforcing effects through facilitation of -aminobutyric acid function and inhibition of glutaminergic pathways in the corticomesolimbic system. While topiramate's unique pharmacodynamic profile offers a promising theoretical rationale for use across multiple substance related disorders, heterogeneity both across and within these disorders limits topiramate's broad applicability in treating substance related disorders. We assessed participants at screening (the beginning of week 1; approximately 7 days before randomization) on (1) medical eligibility to meet study inclusion criteria; (2) drinking characteristics for the previous 28 days using timeline follow-back; (3) depressed mood using the MADRS; (4) breath alcohol concentration; and (5) concomitant medications. Print Seizure Medication Can Reduce Alcohol Consumption. Those who engaged in heavy drinking noticed that combining Topamax and alcohol abuse seemed to curb their cravings, and they drank less. An independent statistical analysis was performed by Daniel O. Scharfstein, ScD (see below). 8600 Rockville Pike For both approaches, we analyzed the percentage of heavy drinking days using a repeated-measures model with treatment group, center, week, sex, baseline percentage of heavy drinking days, chronological age, age at onset of problem drinking, and treatmentweek interaction as covariates. When preparing someone for stopping the use or helping them cut back or end their alcohol dependence, Topamax is usually started at a dose of 25 mg per day, steadily increasing until a dose of 75 mg per day is reached. Bottom Line. From 278,000 From 239,000. Early pharmacogenetic studies raise the intriguing possibility of identifying patients likely to respond to topiramate using genetic testing, and initial studies show that topiramate may also be useful in treating cocaine use disorder, smoking cessation and behavioral addictions. Topiramate in the treatment of substance-related disorders: a critical review of the literature. Topiramate has also been used to treat migraines and, more recently, weight loss. Topiramate significantly reduced drinking among alcohol dependent individuals. While the mechanism of action that makes topiramate for alcoholism work is not fully understood, studies seem to indicate that it is effective. The .gov means its official. Secondary self-reported measures of drinking (ie, percentage of days abstinent and drinks per drinking day) were analyzed similarly to the primary efficacy variable. Evaluation of a Rapid Topiramate Titration Scheme for the Early Detection of Cognitive Side Effects. Alcohol, even when consumed on its own, can trigger them. Sometimes, medical professionals will use it for all four purposes, or they may opt to use different medications for different stages: for example, valium for alcohol detox and Topamax for maintenance. From weeks 14 to 16, participants were tapered off their study medication as a safety precaution. To maintain the blind, sealed envelopes containing study medication identification were provided to the investigators, who were instructed that this envelope could only be opened if specific emergency treatment would be dictated by knowing the participants' treatment assignment. Epub 2022 Jan 31. Terms of Use| Depression was measured using the MADRS every 2 weeks from weeks 0 to 14. In this framework, topiramate may represent a useful treatment option, although its use is not yet approved for AUDs. CDT, GGT, and AST as markers of alcohol use: the WHO/ISBRA collaborative project. Topiramatebrand name Topamaxis a prescription medication designed to treat seizure disorders. In a randomised, placebo-controlled clinical trial, there was a large effect size for topiramate in people homozygous for the GRIK1 rs2832407*C allele. 2023 Jan 19;20(3):1870. doi: 10.3390/ijerph20031870. Depending on the phase, different priorities . Epub 2020 Aug 18. Review of topiramate: an antiepileptic for the treatment of alcohol dependence. All analyses were conducted using both the method of imputing missing data with the baseline value (ie, the primary analytic approach) and the prespecified analysis, which did not impute missing data. This can result in pregnancy. Anyone who is struggling with alcoholism should seek help from experts. Topamax has numerous off-label uses. Nevertheless, with respect to how people fare, on average, following treatment for alcoholism in a clinical trial, a meta-analysis of recent studies has shown that, even after a single treatment event, most can show substantial reductions in drinking up to 1 year afterward.17. An official website of the United States government. To register for email alerts, access free PDF, and more, Get unlimited access and a printable PDF ($40.00), 2023 American Medical Association. ConclusionTopiramate is a promising treatment for alcohol dependence. 2022 Dec;36(12):1325-1330. doi: 10.1007/s40263-022-00969-3. In the topiramate group, one participant had myopia and another had cholelithiasis. Even though we used the inverse-weighting method to show that the differential dropout rate, which was higher in the topiramate group, had little effect on outcome for the primary outcome variable (ie, percentage of heavy drinking days), we reported an even more conservative analysis of imputing all missing data with the baseline value as the primary analytic approach. Of note, between-treatment differences on any of the above measures remained highly significant even when we applied the Hochberg step-up multiple testing procedure to control the family-wise type I error rate, with the very conservative assumption that these measures were independent. Epub 2010 Mar 9. 2022 May 2;5(5):e2213014. There was a predictable and significant relationship between the topiramate dose administered and the serum concentration achieved (r=0.71; P<.001). Medications for the Treatment of Alcohol Dependence-Current State of Knowledge and Future Perspectives from a Public Health Perspective. being able to get an erection, but not having it last long enough for sex. Accessibility Statement, Our website uses cookies to enhance your experience. These side effects include trouble concentrating or speaking, sleepiness, confusion, and dizziness. 2009 May;2(2):135-42. doi: 10.2174/1874473710902020135. This is a big reason why it is used in alcohol dependence treatment. Accessibility Dr Mann reported receiving consulting fees and clinical trial contracts from Alkermes Inc, Janssen, Sanofi-Aventis, Pfizer, Lipha Pharmaceuticals, Ortho-McNeil Janssen Scientific Affairs LLC, and Forest Pharmaceuticals. We compared the cumulative probability functions using the log-rank test. We managed data according to the International Conference on Harmonisation guidelines of good clinical practice. BohnMJ, BaborTF, KranzlerHR. 2023 American Medical Association. 65 m. being unable to get an erection at any time. Acquisition of data: Johnson, Capece, Wiegand, Beyers, McKay, Ait-Daoud, Anton, Ciraulo, Kranzler, OMalley, Swift. Table of contents What is topiramate? It would, therefore, be of clinical interest to determine whether a smaller ceiling dose of topiramate than that targeted in this study (ie, topiramate dose <300 mg/d) would be as efficacious over the length of the trial period. Take advantage of this unique opportunity to invest in new property in the heart of Strasbourg. Compared with placebo recipients, topiramate recipients experienced significant reductions not only in self-reported drinking but also on plasma GGT (P<.001 for all comparisons; Table 3). The information provided on this website is not a substitute for professional medical advice. The entirety of the first draft was prepared by Dr Johnson. Our finding in this study that topiramate is a safe and consistently efficacious medication for treating alcohol dependence is scientifically and clinically important. Alcoholism: a controlled trial of treatment and advice.. Disclaimer. Wang H, Lan L, Lan X, Chen P, Liu G, Rong X, Liu L, Kang CY, Yang J, Guan YZ, Zhu XF, Hu J, Yang M, Zheng D, Peng Y. Further, using the Kaplan-Meier method, we calculated the cumulative probability function of reaching 28 or more days of continuous abstinence and 28 or more days of continuous nonheavy drinking for the topiramate and placebo groups. trouble concentrating, remembering, or speaking. WhiteHS, BrownSD, WoodheadJH, SkeenGA, WolfHH. They tend to follow users for short-term use only or do not engage in double-blind studies. This indicates that doctors can use Topamax for alcohol withdrawal as well as alcoholism maintenance. Because people can use alcohol and Topamax at the same time, it is one of the only drugs that can help someone prepare to enter rehab. Data were managed initially and analyzed by Ortho-McNeil Janssen Scientific Affairs LLC and PharmaNet Inc, a contract research organization, and were interpreted by the study authors with input from Ortho-McNeil Janssen Scientific Affairs LLC clinical and statistical staff. official website and that any information you provide is encrypted Curr Opin Psychiatry. Based on its mechanism of action when treating other conditions, it is theorized that it comes down to how it interacts with GABA inhibitory neurotransmitters. The independent statistician also tested the null hypothesis for the primary efficacy variable (ie, percentage of heavy drinking days) using the inverse-probability weighting method15 to determine whether the repeated-measures mixed model accounted adequately for the differential attrition rate between the topiramate and placebo groups. A diary card for recording alcohol consumption also was distributed to the participants at this time. Another concern with the use of topiramate in alcoholics is that it can decrease the effectiveness of hormonal birth control, including pills, patches, shots, and the ring. Once the person stops needing topiramate for alcohol cravings, their doctor will help them steadily decrease their treatment until they can stop, monitoring for signs of relapse throughout. 1997;21(2):144-8 All Rights Reserved. Herv does research in Psychiatry and Neuropsychopharmacology . Efficacy values were validated as correct against case records. The extended-release injectable formulation is approved in USA. Clinical managementimipramine/placebo administration manual: NIMH Treatment of Depression Collaborative Research Program. The bivariate correlations of percentage of heavy drinking days and other self-reported drinking measures were estimated using baseline data. : Topiramate is a non-benzodiazepine anticonvulsant medication with multi-faceted pharmacologic action. It is also reported efficacious as an adjunct in the treatment of alcohol dependence ( 2) and in the management of binge-eating disorder ( 3 ). What are the topiramate side effects in the absence of alcohol? In this regard, the authors conducted a PubMed search of clinical human studies published in English using the following key words: topiramate alcohol dependence, topiramate alcohol withdrawal and topiramate alcoholism. Predicated upon a neuropharmacological conceptual model, there is now solid clinical evidence to support the efficacy of topiramate for the treatment of alcohol dependence. Drinking on Topamax can cause negative side effects, and these can cause long-term problems. Trial completers were participants who completed all 14 weeks of double-blind treatment. We estimated the hazard ratio (HR) of achieving 28 or more days of continuous abstinence and 28 or more days of continuous nonheavy drinking using the Cox proportional hazards model. 2014;75 Suppl 17(Suppl 17):79-88. Inferential comparisons were provided for the response averaged across the entire double-blind phase unless stated otherwise. LinkedIn is the world's largest business network, helping professionals like Abdellatif DENINE discover inside connections to recommended job candidates, industry experts, and business partners. Participants were not allowed to provide written informed consent unless they had a breath alcohol concentration of less than 0.02%. We tested between-treatment differences on a number of self-reported drinking measures and the laboratory drinking measure. In particular, topiramate shows a greater beneficial effect in subjects with a typology of craving characterised by drinking obsessions and automaticity of drinking. It is important to note that Topamax does not stop the body from absorbing alcohol; instead, it blocks the rewards it triggers, decreasing desire. The BBCET was modeled on the clinical management condition in the National Institute of Mental Health collaborative depression trial, which was used as an adjunct to the medication condition for that study.13 Also, the BBCET was used successfully as the psychosocial treatment platform in the previous efficacy trial of topiramate for treating alcohol dependence.3 Trained clinicians, including nurse practitioners, delivered manual-guided BBCET during each week of the double-blind period. Robert H. Cormier Jr, BA, and Chamindi Seneviratne, MD, provided assistance in preparing the manuscript. Topiramate for Treating Alcohol Dependence: A Randomized Controlled Trial | Substance Use and Addiction Medicine | JAMA | JAMA Network ContextHypothetically, topiramate can improve drinking outcomes among alcohol-dependent individuals by reducing alcohol's reinforcing effects through facilitati [Skip to Navigation] The participants and the investigators were blinded to the treatment assignment. An overview of medications for the treatment of alcohol withdrawal and alcohol dependence with an emphasis on the use of older and newer anticonvulsants. Amendments pertained to style and presentation, and no changes were made by the sponsor to the results or their interpretation from the initial draft or the results as presented at that meeting. and transmitted securely. Second, as with most clinical trials in the alcohol dependence field, enrolled participants have to meet criteria enabling the conduct of a safe study. Retention rates at study end among those randomized were 61.2% (112 of 183) for the topiramate group and 76.6% (144 of 188) for the placebo group (P<.001). Do not break, crush, or chew it. doi:10.1001/jama.298.14.1641. MeSH No numerical difference existed between the topiramate and placebo groups in mean breath alcohol concentration; the average reading was 0.002%. The Kaplan-Meier estimates of the cumulative probability function of achieving 28 or more days of continuous nonheavy drinking are presented in Figure 4A using imputed data and in Figure 4B using nonimputed data. Nourredine M, Jurek L, Angerville B, Longuet Y, de Ternay J, Derveaux A, Rolland B. CNS Drugs. Use of Topiramate in the Spectrum of Addictive and Eating Disorders: A Systematic Review Comparing Treatment Schemes, Efficacy, and Safety Features. Enrollment failures were those who received medication at the beginning of week 1 but did not return to the clinic for further assessment. The other problem with this medication is that it increases the suicidal risks. Participants were not allowed to complete assessments during the double-blind period unless they had a breath alcohol concentration of less than 0.04%. While it is common to use Topamax for alcohol withdrawal and abuse, not everyone agrees with this. Generally, alcohol withdrawal scores assessed on the CIWA-Ar were exceedingly low and did not differ between the topiramate and placebo groups (mean difference, 0.01 [95% CI, 0.31 to 0.33]; P=.94). Apartment - Strasbourg, Grand Est, France. resulted in greater success both during inpatient treatment and after, topiramate can be used before an individual stops drinking, follow users for short-term use only or do not engage in double-blind studies, How to Receive Alcohol Treatment That Works for You, Medications For Alcoholism Treatment: Pills To Cope With Withdrawal. Avoid drinking alcohol with Eprontia, Qudexy XR, or Topamax, or avoid for 6 hours before and 6 hours after taking the Trokendi XR capsule. Curr Drug Abuse Rev. Author Affiliations: Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville (Drs Johnson and Ait-Daoud); Ortho-McNeil Janssen Scientific Affairs LLC, Raritan, New Jersey (Drs Rosenthal, Wiegand, Mao, and McKay and Mss Capece and Beyers); Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston (Dr Anton); Division of Psychiatry, Boston University, Boston, Massachusetts (Dr Ciraulo); Department of Psychiatry, University of Connecticut, Farmington (Dr Kranzler); Department of Addictive Behavior and Addiction Medicine, University of Heidelberg, Mannheim, Germany (Dr Mann); Department of Psychiatry, Yale University, New Haven, Connecticut (Dr OMalley); and Department of Psychiatry and Human Behavior, Brown University, Providence, Rhode Island (Dr Swift). ConigraveKM, DegenhardtLJ, WhitfieldJB. Topiramate is an anti-seizure medication that has been recently investigated for the treatment of alcohol use disorder. Secondary outcome measures included other self-reported measures of drinking (percentage of days abstinent; calculated as the number of nondrinking days divided by the number of study days); drinks per drinking day (average of 14 weekly drinks per drinking day ratios; defined as the number of drinks consumed during a given week divided by the number of drinking days for that week); and the laboratory measure of alcohol consumption (plasma GGT). In contrast, in the placebo group, one participant died following a cardiac arrest associated with gastrointestinal tract bleeding and seizures. Treatment of alcohol dependence is a two-phase process, which aims at alcohol withdrawal and subsequent long-term abstinence and relapse prevention. Analysis and interpretation of data: Johnson, Rosenthal, Capece, Wiegand, Mao, Ait-Daoud, Anton, Ciraulo, Kranzler, Mann, OMalley, Swift. During the double-blind period from weeks 0 to 14, participants were assessed weekly on measures of drinking (measured by timeline follow-back using a diary card as a memory guide); vital signs (including BMI); alcohol withdrawal symptoms using the CIWA-Ar; concomitant medications; medication adherence (ie, [tablets dispensed tablets returned]/total tablets prescribed); adverse events; and breath alcohol concentration. We enrolled 371 men and women diagnosed with alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV),4 using the Structured Clinical Interview for the DSM-IV.5. First, while the pattern of adverse events was similar to that found in our previous study,3 the more rapid titration was associated with decreased study adherence with taking the medication. A, The primary analytic approach of imputing missing data with the baseline value is illustrated; the observed numbers of participants in the topiramate group meeting this criterion were 54 of 183 compared with 28 of 188 in the placebo group. Privacy Policy| -, J Addict Dis. Author Contributions: Dr Johnson had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. We present a broad narrative review of the putative mechanism of action and clinical utility of topiramate with regard to AUD and other substance use disorders. 2007 Jul-Aug;35(4):236-42. Is topiramate effective in alcoholism treatment? In addition, the profile of the alcoholic patient who may benefit more from the use of topiramate is outlined. The use of alcohol or other medicines that affect the CNS with topiramate may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Participants classified their race according to 4 choices: white, black, Asian, or other. In contrast, the topiramate dose-serum concordance level was analyzed by regression analysis, and a relationship between serum topiramate level and the percentage of heavy drinking days for those who completed week 14 was examined using a Pearson correlation. Our findings provided validation that individuals with alcohol dependence, while drinking heavily, can be treated safely and reliably with topiramate16 (ie, without establishing abstinence before initiating treatment). If there was a significant difference at week 14, this procedure would be repeated for the preceding weeks until a time point was reached at which there was no difference. Topiramate and matching placebo tablets were provided by Ortho-McNeil Janssen Scientific Affairs LLC (Raritan, New Jersey). Financial Disclosures: Dr Johnson reported being a consultant for Ortho-McNeil Janssen Scientific Affairs LLC, Organon, and TransOral Pharmaceuticals Inc. Drs Rosenthal, Wiegand, Mao, and McKay and Mss Capece and Beyers reported being employees of Ortho-McNeil Janssen Scientific Affairs LLC. Also, 3 separate individuals in the placebo group had a tibial plateau fracture, abnormally elevated serum liver enzymes, and diverticulitis. To 16, participants were not allowed to complete assessments during the double-blind unless... Users for short-term use only or do not break, crush, or other who may more! The response averaged across the entire double-blind phase unless stated otherwise an erection at time... Matching placebo tablets were provided for the treatment of substance-related disorders: a Systematic Review treatment. 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