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Change in non-abstinent WHO drinking risk levels and alcohol dependence: a 3 year follow-up study in the US general population.

ABSTRACT: BACKGROUND:Alcohol dependence is often untreated. Although abstinence is often the aim of treatment, many drinkers prefer drinking reduction goals. Therefore, if supported by evidence of benefit, drinking reduction goals could broaden the appeal of treatment. Regulatory agencies are considering non-abstinent outcomes as efficacy indicators in clinical trials, including reduction in WHO drinking risk levels-very high, high, moderate, and low-defined in terms of mean ethanol consumption (in grams) per day. We aimed to study the relationship between reductions in WHO drinking risk levels and subsequent reduction in the risk of alcohol dependence. METHODS:In this population-based cohort study, we included data from 22?005 drinkers who were interviewed in 2001-02 (Wave 1) and re-interviewed 3 years later (2004-05; Wave 2) in the US National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol consumption (WHO drinking risk levels) and alcohol dependence (at least three of seven DSM-IV criteria in the previous 12 months) were assessed at both waves. We used logistic regression to test the relationship between change in WHO drinking risk levels between Waves 1 and 2, and alcohol dependence at Wave 2. FINDINGS:At Wave 1, 2·5% (weighted proportion) of the respondents were very-high-risk drinkers, 2·5% were high-risk drinkers, 4·8% were moderate-risk drinkers, and most (90·2%) were low-risk drinkers. Reduction in WHO drinking risk level predicted significantly lower odds of alcohol dependence at Wave 2, particularly among very-high-risk drinkers (adjusted odds ratios 0·27 [95% CI 0·18-0·41] for reduction by one level, 0·17 [0·10-0·27] for two levels, and 0·07 [0·05-0·10] for three levels) and high-risk drinkers (0·64 [0·54-0·75] for one level and 0·12 [0·09-0·15] for two levels), and among those with alcohol dependence at Wave 1 (0·29 [0·15-0·57] for one level, 0·06 [0·04-0·10] for two levels, and 0·04 [0·03-0·06] for three levels in very-high-risk drinkers). INTERPRETATION:Our results support the use of reductions in WHO drinking risk levels as an efficacy outcome in clinical trials. Because these risk levels can be readily translated into standard drink equivalents per day of different countries, the WHO risk levels could also be used internationally to guide treatment goals and clinical recommendations on drinking reduction. FUNDING:US National Institute on Alcohol Abuse and Alcoholism, New York State Psychiatric Institute, the Alcohol Clinical Trials Initiative.

SUBMITTER: Hasin DS

PROVIDER: S-EPMC5536861 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Change in non-abstinent WHO drinking risk levels and alcohol dependence: a 3 year follow-up study in the US general population.

Hasin Deborah S DS Wall Melanie M Witkiewitz Katie K Kranzler Henry R HR Falk Daniel D Litten Raye R Mann Karl K O'Malley Stephanie S SS Scodes Jennifer J Robinson Rebecca L RL Anton Raymond R

The lancet. Psychiatry 20170426 6

<h4>Background</h4>Alcohol dependence is often untreated. Although abstinence is often the aim of treatment, many drinkers prefer drinking reduction goals. Therefore, if supported by evidence of benefit, drinking reduction goals could broaden the appeal of treatment. Regulatory agencies are considering non-abstinent outcomes as efficacy indicators in clinical trials, including reduction in WHO drinking risk levels-very high, high, moderate, and low-defined in terms of mean ethanol consumption (i ...[more]

PMID: 28456501

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Project description:BACKGROUND:Abstinence is often the treatment aim for alcohol use disorders (AUD), but this may deter individuals who prefer drinking reduction goals from entering treatment, and be an overly restrictive end point in alcohol clinical trials. Nonabstinent drinking reductions that predict improvement in how individuals feel or function may be useful clinical trial outcomes, for example, reductions in the 4-category World Health Organization (WHO) drinking risk levels. To investigate the clinical relevance of these reductions, we examined their relationship with 2 outcomes of interest to medical providers: liver disease, and positive scores on an alcohol screening measure. METHODS:Current drinkers in a U.S. national survey (n = 21,925) were interviewed in 2001 to 2002 (Wave 1) and re-interviewed 3 years later (Wave 2). WHO drinking risk levels, liver disease, and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) were assessed at both waves. Adjusted odds ratios (aORs) were used to indicate the association of change in WHO drinking risk levels with Wave 2 liver disease and AUDIT-C scores. RESULTS:Wave 1 very-high-risk drinkers who reduced 1, 2, or 3 WHO drinking risk levels had significantly lower odds of Wave 2 liver disease (aORs = 0.34, 0.23, 0.17) and positive AUDIT-C scores (aORs = 0.27, 0.09, 0.03). Wave 1 high-risk drinkers who reduced 1 or 2 WHO risk levels had significantly lower odds of positive AUDIT-C scores (aORs = 0.61, 0.25). Adjusting for alcohol dependence or AUDIT-C scoring variations did not affect results. CONCLUSIONS:In the highest-risk drinkers, reductions in WHO drinking risk levels predicted lower likelihood of liver disease and positive AUDIT-C scores. Results add to findings that reductions in the 4-category WHO drinking risk levels are a meaningful indicator of how individuals feel and function, and could serve as nonabstinent end points in clinical trials. Results also connect the WHO risk drinking levels to commonly used alcohol screening questions, which may be more familiar to healthcare providers.

Project description:BackgroundAlcohol use disorder (AUD) is a highly prevalent public health problem associated with considerable individual and societal costs. Abstinence from alcohol is the most widely accepted target of treatment for AUD, but it severely limits treatment options and could deter individuals who prefer to reduce their drinking from seeking treatment. Clinical validation of reduced alcohol consumption as the primary outcome of alcohol clinical trials is critical for expanding treatment options. One potentially useful measure of alcohol treatment outcome is a reduction in the World Health Organization (WHO, International Guide for Monitoring Alcohol Consumption and Related Harm. Geneva, Switzerland, 2000) risk levels of alcohol use (very high risk, high risk, moderate risk, and low risk). For example, a 2-shift reduction in WHO risk levels (e.g., high risk to low risk) has been used by the European Medicines Agency (2010, Guideline on the Development of Medicinal Products for the Treatment of Alcohol Dependence. UK) to evaluate nalmefene as a treatment for alcohol dependence (AD; Mann et al. 2013, Biol Psychiatry 73, 706-13).MethodsThe current study was a secondary data analysis of the COMBINE study (n = 1,383; Anton et al., ) to examine the association between reductions in WHO risk levels and reductions in alcohol-related consequences and mental health symptoms during and following treatment in patients with AD.ResultsAny reduction in WHO risk drinking level during treatment was associated with significantly fewer alcohol-related consequences and improved mental health at the end of treatment and for up to 1 year posttreatment. A greater reduction in WHO risk drinking level predicted a greater reduction in consequences and greater improvements in mental health.ConclusionsChanges in WHO risk levels appear to be a valid end point for alcohol clinical trials. Based on the current findings, reductions in WHO risk drinking levels during treatment reflect meaningful reductions in alcohol-related consequences and improved functioning.

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Change in non-abstinent WHO drinking risk levels and alcohol dependence: a 3 year follow-up study in the US general population.

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Change in non-abstinent WHO drinking risk levels and alcohol dependence: a 3 year follow-up study in the US general population.

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