Trial reportPsychiatry and clinical neurosciences2019
Nalmefene in alcohol-dependent patients with a high drinking risk: Randomized controlled trial.
Trial report in Psychiatry and clinical neurosciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled 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.
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
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.
- Translational medications development for methamphetamine use disorder: A systematic review of preclinical, human laboratory, and clinical research.Pharmacological reviews · 2026Pooled it
- Efficacy and safety of a digital therapeutic for alcohol dependence: A multicenter, open-label, randomized controlled trial.Psychiatry and clinical neurosciences · 2025Trial
- Nalmefene attenuates neural alcohol cue-reactivity in the ventral striatum and subjective alcohol craving in patients with alcohol use disorder.Psychopharmacology · 2021Trial
- Long-term safety and efficacy of nalmefene in Japanese patients with alcohol dependence.Psychiatry and clinical neurosciences · 2020Trial
- A Prospective Observational Study of AUDIT-based Risk Stratification and Drinking Guidance Provided by Hepatologists in Patients with Alcoholic Liver Disease.Internal medicine (Tokyo, Japan) · 2026Observational
- Naltrexone and Nalmefene as Modern Psychopharmacotherapy for Alcohol Use Disorder: Modulation of Opioid Receptors and Neurobiological Pathways of Alcohol Action.Biomedicines · 2026Review
- Addiction-related problems in Japan: A regional perspective.Addiction (Abingdon, England) · 2026Review
- Synergistic Effect of Combination Treatment of Brexpiprazole and Nalmefene on Ethanol Intake in Rats.Neuropsychopharmacology reports · 2026Article
- Reductions in World Health Organization Risk Drinking Levels as a Primary Efficacy End Point for Alcohol Clinical Trials: A Review.JAMA psychiatry · 2025Review
- Impact of Alcohol Intake on Body Composition in Patients with Steatotic Liver Disease.Nutrients · 2025Article
- Impact of Alcohol Intake on Skeletal Muscle: A Large Cross-Sectional Analysis in Japanese Adults.Nutrients · 2025Article
- Significance of Fib4 index as an indicator of alcoholic hepatotoxicity in health examinations among Japanese male workers: a cross-sectional and retrospectively longitudinal study.European journal of medical research · 2023Article
- Kappa Opioid Signaling at the Crossroads of Chronic Pain and Opioid Addiction.Handbook of experimental pharmacology · 2022Article
- Endogenous opioid systems alterations in pain and opioid use disorder.Frontiers in systems neuroscience · 2022Review
- Management of alcohol use disorder in patients with cirrhosis in the setting of liver transplantation.Nature reviews. Gastroenterology & hepatology · 2022Review
- Contribution of TSPO imaging in the understanding of the state of gliosis in substance use disorders.European journal of nuclear medicine and molecular imaging · 2021Review
- Alcohol-Related Liver Disease: Basic Mechanisms and Clinical Perspectives.International journal of molecular sciences · 2021Review
- [Pharmacotherapy of alcohol withdrawal: update and new developments].Der Nervenarzt · 2021Review
- Response to 'Nalmefene in alcohol-dependent patients with a high drinking risk: A limited efficacy in reducing alcohol consumption'.Psychiatry and clinical neurosciences · 2020Article
- Five Priority Areas for Improving Medications Development for Alcohol Use Disorder and Promoting Their Routine Use in Clinical Practice.Alcoholism, clinical and experimental research · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
Abstract
aimsReducing alcohol consumption is one treatment approach for alcohol-dependent patients. This study compared nalmefene 20 mg and 10 mg with placebo, combined with psychosocial support, in alcohol-dependent Japanese patients with a high or very high drinking risk level (DRL).
methodsThis was a multicenter, randomized, double-blind, phase 3 study conducted in alcohol-dependent patients with a high or very high DRL. Patients were randomized to 24 weeks of treatment with as-needed nalmefene 20 mg, 10 mg, or placebo with psychosocial support. The primary endpoint was change in heavy drinking days (HDD) from baseline to week 12. A key secondary endpoint was the change in total alcohol consumption (TAC) from baseline to week 12.
resultsAt week 12, 234, 206, and 154 patients who received placebo, nalmefene 20 mg, and 10 mg were included in the primary endpoint analysis. Compared with placebo, nalmefene was associated with significant reductions in HDD at week 12 (difference in 20 mg group, -4.34 days/month; 95% confidence interval [CI]: -6.05 to -2.62; P < 0.0001; difference in 10 mg group, -4.18 days/month; 95%CI: -6.05 to -2.32; P < 0.0001), as well as a significant reduction in TAC at week 12 (P < 0.0001). The incidence of treatment-emergent adverse events was 87.9%, 84.8%, and 79.2% in the groups receiving nalmefene 20 mg, 10 mg, and placebo, respectively. These events were mostly of mild or moderate severity.
conclusionsNalmefene 20 mg or 10 mg effectively reduced alcohol consumption and was well tolerated in alcohol-dependent patients with a high or very high DRL.
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What OpenQuestion holds
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.