Research on the core version of the Alcohol Use Disorders Identification Test (AUDIT) is reviewed. Sensitivities and specificities of the AUDIT or criteria of current hazardous use and, to a slightly lesser extent, lifetime alcohol dependence are high. In general, AUDIT scores are at least moderately related to other self-report alcohol screening tests. Several studies also show them as correlated with biochemical measures of drinking. Results of the AUDIT have also been associated with more distal indicators of problematic drinking. Indices of internal consistency, including Cronbach's alpha and item-total correlations, are generally in the 0.80's. Future directions for research on the AUDIT are suggested.
Objectives
To assess the efficacy and safety of varenicline (Chantix®) for the treatment of alcohol use disorders. Varenicline is a partial α4β2 nicotinic acetylcholine agonist approved by the Food and Drug Administration for smoking cessation. It has reduced drinking in animal studies and in small studies of humans who were both heavy drinkers and smokers. This is the first multisite clinical trial of varenicline in a population of smokers and nonsmokers with alcohol use disorders.
Methods
Men and women (n=200) meeting the criteria for alcohol dependence were recruited across 5 clinical sites. Patients received double-blind varenicline or placebo and a computerized behavioral intervention. Varenicline was titrated during the first week to 2 mg/day, which was maintained during weeks 2–13.
Results
The varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference=10.4), drinks per day, drinks per drinking day, and alcohol craving compared with the placebo group (p values < 0.05). The average treatment effect on alcohol use was similar for smokers and nonsmokers. Varenicline was well-tolerated; adverse events were expected and mild.
Conclusions
Varenicline significantly reduced alcohol consumption and craving, making it a potentially viable option for the treatment of alcohol use disorders.
Research on the core version of the Alcohol Use Disorders Identification Test (AUDIT) is reviewed. Sensitivities and specificities of the AUDIT or criteria of current hazardous use and, to a slightly lesser extent, lifetime alcohol dependence are high. In general, AUDIT scores are at least moderately related to other self-report alcohol screening tests. Several studies also show them as correlated with biochemical measures of drinking. Results of the AUDIT have also been associated with more distal indicators of problematic drinking. Indices of internal consistency, including Cronbach's alpha and item-total correlations, are generally in the 0.80's. Future directions for research on the AUDIT are suggested.
More than 76 million people worldwide are estimated to have diagnosable Alcohol Use Disorders (AUDs) (alcohol abuse or dependence), making these disorders a major global health problem. Pharmacotherapy offers promising means for treating AUDs, and significant progress has been made in the past 20 years. The U.S. Food and Drug Administration approved three of the four medications for alcoholism in the last two decades. Unfortunately, these medications do not work for everyone, prompting the need for a personalized approach to optimize clinical benefit or more efficacious medications that can treat a wider range of patients, or both. To promote global health, the potential reorganization of the National Institutes of Health (NIH) must continue to support the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA’s) vision of ensuring the development and delivery of new and more efficacious medications to treat AUDs in the coming decade. To achieve this objective, the NIAAA Medications Development Team has identified three fundamental long-range goals: 1) to make the drug development process more efficient; 2) to identify more efficacious medications, personalize treatment approaches, or both, and 3) to facilitate the implementation and adaptation of medications in real-world treatment settings. These goals will be carried out through seven key objectives. This paper describes those objectives in terms of rationale and strategy. Successful implementation of these objectives will result in the development of more efficacious and safe medications, provide a greater selection of therapy options, and ultimately lessen the impact of this devastating disorder.
PSNHDD appears to be a clinically informative end point measure, especially when used with a grace period, and is as sensitive as most traditional outcome measures in detecting differences between the medication and placebo groups. Nonetheless, these findings should be replicated in other clinical data sets, particularly with medications that work via different mechanisms.
Background
Alcohol dependence often goes untreated. Although abstinence is often the aim of alcohol 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 clinical trial efficacy indicators, including reduction in the World Health Organization (WHO) drinking risk levels: very high, high, moderate and low, defined in terms of average grams of ethanol per day. Little is known about the relationship between reductions in WHO risk levels and subsequent reduction in the risk for alcohol dependence.
Methods
In a U.S. national sample, 22 005 drinkers participated in Wave 1 interviews in 2001–2002 and Wave 2 follow-ups 3 years later. Alcohol consumption and alcohol dependence were assessed at both waves. Logistic regression tested the relationship between change in WHO drinking risk levels between Waves 1 and 2, and Wave 2 alcohol dependence.
Findings
Reductions of 1, 2 or 3 WHO risk levels predicted significantly lower odds of alcohol dependence at Wave 2, particularly among very high and high risk drinkers at Wave 1, and among those with alcohol dependence at Wave 1.
Interpretation
Results support the use of reductions in WHO drinking risk levels as clinical trial efficacy indicators. Because the levels can readily be translated into average drinks per day using the standard drink equivalents of different countries, the WHO risk levels could also be used internationally to guide treatment goals and clinical recommendations on drinking reduction.
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