Trial reportAlcoholism, clinical and experimental research2017
Temporal Stability of Heavy Drinking Days and Drinking Reductions Among Heavy Drinkers in the COMBINE Study.
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. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Examining the Impact of Trial Length on Detecting Medication Effects for Alcohol Use Disorder: A Meta-Regression Study.Alcohol, clinical & experimental research · 2026Pooled it
- Engagement in alcohol-free activities, community-level economic disadvantage, and heavy drinking following alcohol treatment.Journal of the experimental analysis of behavior · 2026Trial
- Potential predictors affecting outcomes in a randomized controlled trial of support programs for parents of young adults with hazardous substance use.Addiction science & clinical practice · 2025Trial
- Predictors of treatment outcome for individuals with alcohol use disorder with a goal of controlled drinking.Addiction science & clinical practice · 2024Trial
- Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial.The American journal of psychiatry · 2024Trial
- Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study.Journal of substance use and addiction treatment · 2023Trial
- Effectiveness of Varenicline and Cytisine for Alcohol Use Reduction Among People With HIV and Substance Use: A Randomized Clinical Trial.JAMA network open · 2022Trial
- Maintenance of World Health Organization Risk Drinking Level Reductions and Posttreatment Functioning Following a Large Alcohol Use Disorder Clinical Trial.Alcoholism, clinical and experimental research · 2019Trial
- Manifestation of Drinking Profiles in Daily Life: Associations With Momentary Negative Affect, Impulsivity, and Drinking.Alcohol, clinical & experimental research · 2026Article
- Neural, Motivational, and Psychological Measures of Pain Avoidance Predict Future Alcohol Use in Adult Drinkers.Addiction biology · 2025Article
- Neural Correlates of Stress and Alcohol Cue-Induced Alcohol Craving and of Future Heavy Drinking: Evidence of Sex Differences.The American journal of psychiatry · 2024Article
- Transcutaneous electrical acupoint stimulation in adult patients receiving gastrectomy/colorectal resection: A randomized controlled trial.World journal of gastrointestinal surgery · 2023Article
- The relationship of frequency of cocaine use to substance and psychiatric disorders in the U.S. general population.Drug and alcohol dependence · 2021Article
- Reduction in World Health Organization Risk Drinking Levels and Cardiovascular Disease.Alcoholism, clinical and experimental research · 2020Article
- Capturing habitualness of drinking and smoking behavior in humans.Drug and alcohol dependence · 2020Article
- Prevention, screening, and treatment for heavy drinking and alcohol use disorder.The lancet. Psychiatry · 2019Review
- Reduction in non-abstinent World Health Organization (WHO) drinking risk levels and drug use disorders: 3-year follow-up results in the US general population.Drug and alcohol dependence · 2019Article
- Article
- Reduction in non-abstinent WHO drinking risk levels and depression/anxiety disorders: 3-year follow-up results in the US general population.Drug and alcohol dependence · 2019Article
- Reduction in Nonabstinent WHO Drinking Risk Levels and Change in Risk for Liver Disease and Positive AUDIT-C Scores: Prospective 3-Year Follow-Up Results in the U.S. General Population.Alcoholism, clinical and experimental research · 2018Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
backgroundRecently, the Food and Drug Administration (FDA) proposed to expand the options for primary end points in the development of medications for alcohol use disorder to include either abstinence from alcohol or a nonabstinent outcome: no heavy drinking days (with a heavy drinking day defined as more than 3 drinks per day for women and more than 4 drinks per day for men [>3/>4 cutoff]). The FDA also suggested that 6 months would be the most appropriate length for a clinical trial to demonstrate the stability of this nonabstinent drinking outcome. However, few alcohol clinical trials have examined the stability of nonheavy drinking during and after treatment.
methodsIn a secondary analysis of the COMBINE study data (n = 1,383), we examined transitions in heavy drinking days during the course of treatment (months 1 through 4), during the transition out of treatment (months 4 through 7), and up to 12 months afterward (months 13 through 16) using latent variable mixture models.
resultsHeavy drinking and nonheavy drinking were relatively stable in consecutive months (minimum agreement [kappa] = 0.64 for months 1 to 2). Most individuals were stable low-risk drinkers/abstainers or heavy drinkers by the end of treatment, as characterized by a 10% probability (or less) of transitioning out of either a no heavy drinking state or a heavy drinking state. More than two-thirds of the heavy drinkers who exceeded the heavy drinking threshold during treatment reported, on average, a 64% reduction in drinking frequency and a 38% reduction in drinking intensity from pretreatment drinking levels.
conclusionsThe results show stability of no heavy drinking as an outcome within the first 4 months of treatment and that the >3/>4 drink cutoff may mask substantial reductions in alcohol consumption among some patients. Future studies should explore the clinical utility of reduction end points.
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