Evidence map›Paper›PMID 28019652›Full record

Trial reportAlcoholism, clinical and experimental research2017

Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels.

Katie Witkiewitz, Kevin A Hallgren, Henry R Kranzler, Karl F Mann, Deborah S Hasin, Daniel E Falk, Raye Z Litten, Stephanie S O'Malley, Raymond F Anton

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05509166 (A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking), which is not on this map. Cited by 102 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05509166 narecruitingnot on this mapstarted 2023, after this paper: background citation

A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking

TypeinterventionalSponsorYale UniversityRan2023 to 2027Enrolled274ConditionsHeavy Drinking, Mental Health IssueArmsLGBTQ-affirmative Cognitive Behavioral Therapy, LGBTQ-affirmative Treatment-As-Usual
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  11. World Health Organization (WHO) risk level reductions in inpatients with alcohol use disorder and comorbid anxiety disorders.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2023
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  13. Characterizing cannabis use reduction and change in functioning during treatment: Initial steps on the path to new clinical endpoints.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2022
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  14. Evaluating cannabis use risk reduction as an alternative clinical outcome for cannabis use disorder.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2022
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  18. Initial efficacy of a web-based alcohol and emotion regulation intervention for college women with sexual assault histories.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2021
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42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Katie WitkiewitzDepartment of Psychology, University of New Mexico, Albuquerque, New Mexico.
Kevin A HallgrenDepartment of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington.
Henry R KranzlerDepartment of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania.
Karl F MannDepartment of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, Mannheim, Germany.
Deborah S HasinDepartment of Psychiatry, Mailman School of Public Health, Department of Epidemiology, Columbia University, New York City, New York.
Daniel E FalkNational Institute on Alcohol Abuse and Alcoholism, National Insitutes of Health, Rockville, Maryland.
Raye Z LittenNational Institute on Alcohol Abuse and Alcoholism, National Insitutes of Health, Rockville, Maryland.
Stephanie S O'MalleyDepartment of Psychiatry, Substance Abuse Treatment Unit, Yale University, New Haven, Connecticut.
Raymond F AntonMedical University of South Carolina, Charleston, South Carolina.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
TREATING ETHANOL WITHDRAWAL WITH LORAZEPAM/NALTREXONEP50AA010761 · NIAAA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Patrick J. Mulholland · 1996 to 2026
$46.8M
Psychology Training in Alcohol Research (PTAR)T32AA007455 · NIAAA · UNIVERSITY OF WASHINGTON · PI MARY E. LARIMER · 1985 to 2026
$11.4M
Precision Medicine and Recovery in a Telehealth Treatment Program for Alcohol Use DisorderR01AA022328 · NIAAA · UNIVERSITY OF NEW MEXICO · PI Katie A Witkiewitz · 2013 to 2026
$3.1M
Drinking levels (binge, volume) and alcohol consequences: using national data to identify clinical trial endpoints - Administrative SupplementR01AA025309 · NIAAA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI HASIN, DEBORAH S · 2016 to 2021
$925k
NCATS NIH HHS UL1 TR001863NIAAA NIH HHS P50 AA010761NIAAA NIH HHS R01 AA022328NIAAA NIH HHS R01 AA025309NIAAA NIH HHS T32 AA007455
6 · The paper itself

Abstract

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.

Indexed as

World Health OrganizationAdultAlcohol DrinkingAlcoholismDouble-Blind MethodFemaleFollow-Up StudiesHealth SurveysHumansLongitudinal StudiesMaleMiddle AgedRisk FactorsTreatment OutcomeAlcohol DependenceAlcohol Treatment OutcomesHarm ReductionReduced Alcohol ConsumptionWorld Health Organization Risk Drinking Levels

Identifiers

PMID28019652
PMCPMC5205540

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.