Evidence map›Paper›PMID 31753736›Full record

Trial reportDrug and alcohol dependence2020

Extended release mixed amphetamine salts and topiramate for cocaine dependence: A randomized clinical replication trial with frequent users.

Frances R Levin, John J Mariani, Martina Pavlicova, C Jean Choi, Amy L Mahony, Daniel J Brooks, Adam Bisaga, Elias Dakwar, Kenneth M Carpenter, Nasir Naqvi and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Quality-of-life improvements associated with reductions in cocaine-positive urine drug screens.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2026
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  11. Open-label pilot study of lisdexamfetamine for cocaine use disorder.The American journal of drug and alcohol abuse · 2021
    Trial
  12. Stimulant Treatment Gap in ADHD Patients with Heroin Use Disorder: Clinical and Behavioural Consequences.International journal of environmental research and public health · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Frances R LevinNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA. Electronic address: frl2@columbia.edu.
John J MarianiNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.
Martina PavlicovaDepartment of Biostatistics, Columbia University, 722 West 168(th) Street, New York, NY 10032 USA.
C Jean ChoiNew York State Psychiatric Institute, Division of Biostatistics, 1051 Riverside Drive, New York, NY 10032 USA.
Amy L MahonyNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA.
Daniel J BrooksNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA.
Adam BisagaNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.
Elias DakwarNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.
Kenneth M CarpenterNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.
Nasir NaqviNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.
Edward V NunesNew York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY 10032 USA; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168(th) Street, New York, NY 10032 USA.
Kyle KampmanDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Philadelphia, PA, 19104 USA.
New York State Psychiatric InstituteUniversity of Pennsylvania · US

Funding

2/2 Multicenter trial of combined pharmacotherapy to treat cocaine dependenceU01DA033368 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI KAMPMAN, KYLE MATTHEW · 2013 to 2015
$2.3M
1/2-Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine DependenceU01DA033310 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI LEVIN, FRANCES RUDNICK · 2013 to 2015
$2.2M
Substance Abuse Treatment Development and Clinical Research MentoringK24DA029647 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LEVIN, FRANCES RUDNICK · 2010 to 2019
$1.8M
NIDA NIH HHS K24 DA029647NIDA NIH HHS U01 DA033310NIDA NIH HHS U01 DA033368
6 · The paper itself

Abstract

backgroundCocaine use disorder (CUD) remains a substantial public health problem with no clearly effective pharmacotherapy available. In a prior trial, combined amphetamine and topiramate treatment significantly reduced cocaine use among individuals demonstrating the most frequent use at baseline. This trial targeted such frequent users.

methodsA double-blind, randomized placebo-controlled trial, testing the combination of mixed amphetamine salts extended-release (MAS-ER) and topiramate or placebo over a 12-week medication phase was conducted. The two-site outpatient trial included 127 adults (96 males) with CUD using at least 9 days in the prior month. MAS-ER was titrated to a maximum dose of 60 mg/day and topiramate to a maximum dose of 100 mg twice/day. The primary outcome was the proportion of individuals who achieved three consecutive abstinent weeks at the end of the study (EOS) as measured by urine toxicology and self-report.

resultsThe proportion of participants achieving three abstinent weeks at the EOS was significantly (P = .03) larger in the treatment (14.1%) compared to the placebo group (0.0%), while controlling for baseline cocaine use, sex, current alcohol use disorder, and site. Of note, due to conservative cardiac safety-parameters a considerable number of individuals in the treatment group were discontinued from study medication (20.3%).

conclusionsWhile these findings provide further evidence that the combination of MAS-ER and topiramate is efficacious in promoting abstinence in CUD adults with frequent use it remains possible that the combination treatment is no more effective than either treatment alone. Despite this, the study provides a valuable "proof of concept."

Indexed as

AmphetaminesCocaine-Related DisordersDelayed-Action PreparationsDouble-Blind MethodDrug MonitoringDrug Therapy, CombinationFemaleHumansMaleMiddle AgedSaltsTopiramateTreatment OutcomeAmphetaminesDelayed-Action PreparationsSaltsTopiramateAmphetaminesClinical trialCocaine dependenceSubstance dependenceTopiramateTreatment

Identifiers

PMID31753736
PMCPMC6980777
OpenAlexW2984929742

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.