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New treatments in alcohol use disorders

Patients with alcohol dependence can differ in many traits with different genetic vulnerabilities and biological risk factors, and different environmental backgrounds. The “ideal” and effective drug for all types of alcoholic patients does not exist and it is essential to identify a personalized approach for individual patients. Progress in pharmacology and better understanding of the neurobiology of addiction have resulted in a broad spectrum of pharmacological treatments with drugs indicated for alcohol withdrawal and relapse prevention on one side of the spectrum, and reduction of alcohol consumption in patients with alcohol dependence on the other. In his video presentations, Wim van den Brink discusses the neurobiology of addiction and gives an overview of the current pharmacological treatments available for alcohol dependence, with a special focus on the new drug nalmefene.
Psychosocial support is an essential component in the treatment of alcohol use disorders. With the rapid rise of social media and new technology, there are new options for technology-based interventions like supportive text messaging, apps, psychoeducational websites, and computerized cognitive behavioural therapy to help patients to achieve and maintain treatment goals. Join Conor Farren’s presentations for an outlook on the future horizons of patient care using social media and new technology.

  • Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level

    Wim van den Brink, Henri-Jean Aubin, Anna Bladström, Lars Torup, Antoni Gual, Karl Mann

    Alcohol and Alcoholism 2013, Volume 48, pages 570–578

    Editor's comment:
    The authors investigated the efficacy and safety of as-needed use of nalmefene 18 mg versus placebo in reducing alcohol consumption in a subgroup of patients with at least a high drinking risk level at both screening and randomization from the two randomized controlled 6-month studies ESENSE 1 and ESENSE 2. All the patients also received a motivational and adherence-enhancing intervention. Findings from this post hoc analysis include a superior effect of nalmefene compared with placebo in reducing the number of heavy drinking days and total alcohol consumption at Month 6. Improvements in clinical status and liver parameters were greater in the nalmefene group compared with the placebo group. Adverse events and adverse events leading to dropout were more common with nalmefene than placebo. Based on this post hoc analysis, the authors conclude that nalmefene as-needed should be offered to those alcohol-dependent patients in primary care and outpatient addiction treatment services who are not able to reduce their alcohol consumption following an initial assessment or brief intervention. 

  • New pharmacological treatment strategies for relapse prevention

    Rainer Spanagel and Valentina Vengeliene

    Current Topics in Behavioral Neurosciences 2013, Volume 13, pages 583–609

    Editor's comment:
    Acknowledging the value of non-pharmacological interventions, the authors focus in their review paper on treatment strategies that are based on pharmacological interventions. No other field in psychiatric research has yielded as many promising approaches in target definition and drug development as that for alcohol addiction. Learning from other addictive substances as well as making use of new pharmacological and pharmacogenetic findings will be very helpful in the further development of treatment strategies. A combination of behavioral and pharmacological therapies might be the optimal approach, and the whole organism has to be taken into consideration to provide the best therapy.

  • Doing it by numbers: A simple approach to reducing the harms of alcohol

    David J. Nutt and Jürgen Rehm

    Journal of Psychopharmacology 2014, Volume 28, pages 3–7

    Editor's comment:
    The authors present a clear, simple and evidence-based approach to reducing the public and personal harms and costs of alcohol-attributable health damage – a new approach that focuses on numbers, not on disease of diagnosis, and which by this lacks stigmatizing issues. They present a 10-point plan, including an approach focused on quantifying grams of alcohol intake and number of alcohol-free days on the individual user’s side. Governments, for their side, should take alcohol grams as basis for pricing and require the amount of grams of alcohol to be included on bottle label information, and should impose restrictions on the number of places and hours where strong alcohol can be bought. The authors also argue for a widening of treatments and a better use of the existing effective psychosocial and pharmacological treatments. Alcohol should be a public health priority.

  • Effect of modafinil on impulsivity and relapse in alcohol dependent patients: A randomized, placebo-controlled trial

    Leen Joos, Anna E. Goudriaan, Lianne Schmaal, Erik Fransen, Wim van den Brink, Bernard G.C. Sabbe, Geert Dom

    European Neuropsychopharmacology 2013, Volume 23, pages 948–955

    Editor's comment:
    This study is the first randomized double-blind placebo-controlled trial conducted with modafinil in treatment-seeking alcohol dependent patients. The authors hypothesized that a 10-week treatment with modafinil in alcohol dependent patients would reduce relapse and relapse severity during treatment and after treatment discontinuation, and would reduce impulsivity. Overall, the use of modafinil was well tolerated and no abuse potential of modafinil was reported. The study found no significant main effects of modafinil for the primary alcohol outcome variables compared to placebo. Subgroup analysis revealed that modafinil prolonged the time to relapse and tended to increase the percentage of abstinent days in alcohol dependent patients with poor response inhibition at baseline, whereas modafinil increased the percentage of heavy drinking days and reduced the percentage of abstinent days in patients with better baseline response inhibition. Although no significant effect of modafinil was detected on the risk of relapse in alcohol dependence according to this RCT, patients with poor "response inhibition" trait might get benefit from modafinil, although a study specifically designed for this hypothesis to draw definite conclusions would be welcome.

  • Long-term efficacy, tolerability and safety of nalmefene as-needed in patients with alcohol dependence: A 1-year, randomised controlled study

    Wim van den Brink, Per Sørensen, Lars Torup, Karl Mann, Antoni Gual, for the SENSE Study Group

    Journal of Psychopharmacology 2014, Volume 28, pages 733–744

    In this study conducted in 10 European countries to assess long-term efficacy, tolerability and safety of nalmefene, 675 alcohol-dependent patients were randomized to nalmefene-as-needed or placebo. 62% of the nalmefene-treated patients in the total population completed the 1-year study, indicating that the drug was well tolerated. In a subgroup of patients with high/very high drinking risk levels, there was a significant effect in favour of nalmefene on the reduction of total alcohol consumption at month 6, and on the number of heavy drinking days and total alcohol consumption at month 13. These findings further support that nalmefene as-needed is effective in patients with high/very high drinking risk levels at the start of treatment, and has the potential to engage alcohol-dependent patients in a treatment aimed at reducing their alcohol consumption.

  • Baclofen for alcohol dependence in France: Incidence of treated patients and prescription patterns—A cohort study

    Julie Dupouy, Jean-Pascal Fournier, Émilie Jouanjus, Aurore Palmaro, Jean-Christophe Poutrain, Stéphane Oustric, Maryse Lapeyre-Mestre

    European Neuropsychopharmacology 2014, Volume 24, pages 192–199

    Editor's comment:
    This pharmacoepidemiological retrospective cohort study aims to describe the incidence of patients newly treated with baclofen for alcohol dependence in France from 2007 to 2011. Secondary aim of the study was to describe prescription patterns and prescribers. The study has found a rapid spread of baclofen use in France for alcohol dependence – an increase by a factor of 2.9 between 2007 and 2011. Median duration of baclofen treatment for alcohol dependence was 143.5 days and, in the majority of cases, with low doses (median daily dose 24.4 mg). In the majority of cases, the first prescriber was a non-hospital physician whose specialty was general medicine. In France, baclofen has received in 2014 a special authorization (Temporary Recommendation of Use) as prescription for alcohol dependence. In some other European countries, the drug is used off-label for the treatment of alcohol dependence.

  • The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model

    Philippe Laramée, Thor-Henrik Brodtkorb, Nora Rahhali, Chris Knight, Carolina Barbosa, Clément François, Mondher Toumi, Jean-Bernard Daeppen, Jürgen Rehm

    BMJ Open 2014;4:e005376 doi:10.1136/bmjopen-2014-005376

    Most dose–response curves for alcohol consumption on disease and injury outcomes are exponential, and heavy drinking, both episodic and chronic, has a major impact on the burden of alcohol related disease. High levels of alcohol consumption can also prove economically costly through costs related to treatment, to productivity losses and to losses due to alcohol-related crime and accidents. This study reports on a Markov model used to evaluate, as a primary objective, whether nalmefene used in combination with psychosocial support was cost-effective compared with psychosocial support alone in alcohol dependent patients with a high/very high drinking risk level, in line with the indication for nalmefene. A secondary objective was to evaluate the public health benefit of patients entering treatment for alcohol dependence. Analysis based on 1-year clinical data projected on a 5-year horizon, indicated a considerable benefit from nalmefene plus psychosocial support versus psychosocial support alone, consisting in the avoidance of 7179 alcohol-attributable diseases or injuries and 309 deaths per 100,000 patients, and an incremental cost-effectiveness ratio of GBP 5204 per quality-adjusted life year gained. Simplifications of certain modelling features when extrapolating patients’ trajectories after the trial time horizon represent limitations of the decision model in this study.

  • Efficacy of automated telephone continuing care following outpatient therapy for alcohol dependence

    Gail L. Rose, Joan M. Skelly, Gary J. Badger, Tonya A. Ferraro, John E. Helzer

    Addictive Behaviors 2015, Volume 41, pages 223–231

    Editor's comment:
    This controlled trial shows how novel automated continuing care programs, like in this study the fully automated telephone continuing care program ATIVR (Alcohol Therapeutic Interactive Voice Response) have the potential to help alcohol dependent patients achieving or maintaining goals. While this trial demonstrated a null effect of ATIVR for maintaining cognitive behavioral therapy outcomes in the 12-months following treatment completion, among the target population for continuing care, i.e., those few in the study sample who achieved abstinence with cognitive behavioral therapy, an ATIVR effect was suggested. A statistically significant difference at follow-up on measures of abstinence and excessive drinking, despite the small sample size and low power of this trial, suggests a possible relapse prevention effect. The study results argue for the continued development and refinement of automated methods of support for individuals post-discharge from specialty alcohol treatment. Future automated programs could incorporate more precise algorithms to recognize when “stepping up” of care is warranted, and more active engagement by clinicians when return to professional treatment is indicated. Automated tools that are scalable to large populations, if found to be clinically effective, could substantially save provider time and reduce expenses.