Trial reportAlcoholism, clinical and experimental research2012
A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients.
Trial report in Alcoholism, clinical and experimental research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00498628 (A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers.), which is not on this map. Cited by 42 papers, 2 of them syntheses 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.
A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers.
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.
- Eating cognitions, emotions and behaviour under treatment with second generation antipsychotics: A systematic review and meta-analysis.Journal of psychiatric research · 2023Pooled it
- The placebo effect in clinical trials for alcohol dependence: an exploratory analysis of 51 naltrexone and acamprosate studies.Alcoholism, clinical and experimental research · 2013Pooled it
- The role of baseline insomnia in moderating the hypnotic properties of quetiapine.Addictive behaviors · 2023Trial
- A randomized pilot trial of topiramate for alcohol use disorder in veterans with traumatic brain injury: Effects on alcohol use, cognition, and post-concussive symptoms.Drug and alcohol dependence · 2020Trial
- The Relationship between Alcohol Craving and Insomnia Symptoms in Alcohol-Dependent Individuals.Alcohol and alcoholism (Oxford, Oxfordshire) · 2019Trial
- Safety Assessment of Liver Injury with Quetiapine Fumarate XR Management in Very Heavy Drinking Alcohol-Dependent Patients.Clinical drug investigation · 2016Trial
- An exploratory evaluation of Take Control: A novel computer-delivered behavioral platform for placebo-controlled pharmacotherapy trials for alcohol use disorder.Contemporary clinical trials · 2016Trial
- Dose specific effects of olanzapine in the treatment of alcohol dependence.Psychopharmacology · 2015Trial
- Topiramate treatment of alcohol use disorder in veterans with posttraumatic stress disorder: a randomized controlled pilot trial.Alcoholism, clinical and experimental research · 2014Trial
- A randomized, double-blind, placebo-controlled trial of quetiapine in patients with bipolar disorder, mixed or depressed phase, and alcohol dependence.Alcoholism, clinical and experimental research · 2014Trial
- A double-blind, placebo-controlled trial of topiramate for the treatment of comorbid cocaine and alcohol dependence.Drug and alcohol dependence · 2013Trial
- Developing and validating a human laboratory model to screen medications for smoking cessation.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2012Trial
- Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies.Alcohol and alcoholism (Oxford, Oxfordshire)Trial
- Participant Demographic and Baseline Drinking Factors Can Predict Alcohol Use Disorder Pharmacotherapy Clinical Trial Completion and Drinking Outcomes.Alcohol, clinical & experimental research · 2026Article
- Empirical Derivation and Prediction of Treatment Trajectories in Harmonized AUD Clinical Trial Datasets.Addiction biology · 2025Article
- Predicting individual treatment response in alcohol use disorders: a reverse translational proof-of-concept study.Translational psychiatry · 2025Article
- Treatment of insomnia associated with alcohol and opioid use: a narrative review.Sleep and biological rhythms · 2024Review
- Off-label and investigational drugs in the treatment of alcohol use disorder: A critical review.Frontiers in pharmacology · 2022Review
- The Impact of Exercise and Virtual Reality Executive Function Training on Cognition Among Heavy Drinking Veterans With Traumatic Brain Injury: A Pilot Feasibility Study.Frontiers in behavioral neuroscience · 2022Article
- Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery.Neuropsychopharmacology reports · 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
18 authors at 8 institutions in 1 country.
Funding
Abstract
backgroundDespite advances in developing medications to treat alcohol dependence, few such medications have been approved by the Food and Drug Administration. Identified molecular targets are encouraging and can lead to the development and testing of new compounds. Atypical antipsychotic medications have been explored with varying results. Prior research suggests that the antipsychotic quetiapine may be beneficial in an alcohol-dependent population of very heavy drinkers.
methodsIn this double-blind, placebo-controlled trial, 224 alcohol-dependent patients who reported very heavy drinking were recruited across 5 clinical sites. Patients received either quetiapine or placebo and Medical Management behavioral intervention. Patients were stratified on gender, clinical site, and reduction in drinking prior to randomization.
resultsNo differences between the quetiapine and placebo groups were detected in the primary outcome, percentage heavy-drinking days, or other drinking outcomes. Quetiapine significantly reduced depressive symptoms and improved sleep but had no effect on other nondrinking outcomes. Results from a subgroup analysis suggest that patients who reduced their drinking prior to randomization had significantly better drinking outcomes during the maintenance phase (p < 0.0001). No significant interactions, however, were observed between reducer status and treatment group. Finally, quetiapine was generally well tolerated. Statistically significant adverse events that were more common with quetiapine versus placebo include dizziness (14 vs. 4%), dry mouth (32 vs. 9%), dyspepsia (13 vs. 2%), increased appetite (11 vs. 1%), sedation (15 vs. 3%), and somnolence (34 vs. 9%).
conclusionsThis multisite clinical trial showed no efficacy for quetiapine compared with placebo at reducing alcohol consumption in heavy-drinking alcohol-dependent patients.
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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.