Evidence map›Paper›PMID 29281033›Full record

Trial reportAlcohol and alcoholism (Oxford, Oxfordshire)2018

Comparing and Combining Topiramate and Aripiprazole on Alcohol-Related Outcomes in a Human Laboratory Study.

Carolina L Haass-Koffler, Kimberly Goodyear, William H Zywiak, Lorenzo Leggio, George A Kenna, Robert M Swift

Erratum issued Registry-linked trialOpen access · bronzeAbstract readComparative StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alcohol and alcoholism (Oxford, Oxfordshire), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00884884 (Aripiprazole and Topiramate on Free-Choice Alcohol Use), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% of its field
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.

NCT00884884 phase2 / phase3completednot on this map

Aripiprazole and Topiramate on Free-Choice Alcohol Use

TypeinterventionalSponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Ran2007 to 2015Enrolled90ConditionsAlcohol DependenceArmsDouble Placebo, Aripiprazole 15, placebo, Aripiprazole 7.5, Placebo, Topiramate 100, Placebo, Topiramate 200, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  13. Opioid Craving in Human Laboratory Settings: a Review of the Challenges and Limitations.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Carolina L Haass-KofflerCenter for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, 121 South Main Street, Providence, RI 02912, USA.
Kimberly GoodyearCenter for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, 121 South Main Street, Providence, RI 02912, USA.
William H ZywiakCenter for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, 121 South Main Street, Providence, RI 02912, USA.
Lorenzo LeggioCenter for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, 121 South Main Street, Providence, RI 02912, USA.
George A KennaCenter for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, 121 South Main Street, Providence, RI 02912, USA.
Robert M SwiftCenter for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, 121 South Main Street, Providence, RI 02912, USA.
National Institute on Drug Abuse · USBrown University · USProvidence College · US

Funding

Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIAAA000218 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI LEGGIO, LORENZO · 2013 to 2020
$22.8M
Mifepristone As A Pharmacological Intervention For Stress-Induced Alcohol DrinkingK01AA023867 · NIAAA · BROWN UNIVERSITY · PI HAASS-KOFFLER, CAROLINA LUISA · 2016 to 2020
$901k
NIAAA NIH HHS K01 AA023867
6 · The paper itself

Abstract

aimsThe goal of this study was to evaluate the efficacy of topiramate up to 200 mg/day and of aripiprazole up to 15 mg/day, alone and combined, in reducing alcohol-related outcomes in a human laboratory study.

methodThis was a 5 week, between-subject, double-blind, placebo-controlled human laboratory study with topiramate [0 mg/day (placebo), 100 mg/day, 200 mg/day] and aripiprazole [0 mg/day (placebo), 7.5 mg/day, 15 mg/day] in 90 non-treatment seeking, heavy drinking, alcohol-dependent individuals. Main outcomes were the efficacy of 200 mg/day topiramate and 15 mg/day aripiprazole, alone and combined, in reducing drinks consumed during an alcohol self-administration procedure (human laboratory phase) and while receiving the study medications prior to the laboratory session (naturalistic drinking phase). Other outcomes in the laboratory phase included alcohol craving, and alcohol biphasic effects.

resultsIn the human laboratory phase, topiramate 200 mg/day reduced alcohol craving [**P < 0.01] and amplified alcohol-induced stimulation [*P < 0.05], but did not reduce the number of drinks consumed. Topiramate 200 mg/day was also effective in reducing drinking days [*P < 0.05], and alcohol craving [*P < 0.05], in the naturalistic drinking phase. No significant findings were found for aripiprazole for any of the outcomes analyzed.

conclusionParticipants receiving 200 mg/day topiramate reported reduced alcohol drinking and craving, and increased alcohol-related stimulation. These findings provide further support for the role of topiramate as a pharmacological treatment for AUD. CLINICALTRIAL.GOV IDENTIFIER: NCT00884884. SHORT SUMMARY: This study tested topiramate and aripiprazole alone and in combination. The results replicate past findings and suggest that topiramate may be an effective treatment for alcohol use disorder. The present results suggest that the combination of topiramate and aripiprazole do not warrant further evaluation.

Indexed as

Alcoholic BeveragesAdultAlcoholismAnticonvulsantsAntipsychotic AgentsAripiprazoleDouble-Blind MethodDrug Therapy, CombinationFemaleFructoseHumansMaleMiddle AgedTopiramateTreatment OutcomeAnticonvulsantsAntipsychotic AgentsAripiprazoleFructoseTopiramate

Identifiers

PMID29281033
PMCPMC5913672
OpenAlexW2776033723

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.