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

Levin, Frances R.; Mariani, John J.; Pavlicova, Martina; Choi, C. Jean; Mahony, Amy L.; Brooks, Daniel J.; Bisaga, Adam; Dakwar, Elias; Carpenter, Kenneth M.; Naqvi, Nasir; Nunes, Edward V.; Kampman, Kyle

doi:10.1016/j.drugalcdep.2019.107700

Cited by 54Substance Abuse Treatment and OutcomesNeurotransmitter Receptor Influence on BehaviorOpioid Use Disorder Treatment

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

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Levin, Frances R., Mariani, John J., Pavlicova, Martina, Choi, C. Jean, Mahony, Amy L., Brooks, Daniel J., Bisaga, Adam, Dakwar, Elias +4 more·2020·Drug and Alcohol Dependence

DOI 10.1016/j.drugalcdep.2019.107700PMC PMC6980777

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Abstract

Background Cocaine 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.Methods A 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.Results The 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%).Conclusions While 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."

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Extended-Release Mixed Amphetamine Salts and Topiramate for Cocaine Dependence: A Randomized Controlled Trial
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Authors: Levin, F. R., Mariani, J. J., Pavlicova, M., Choi, C. J., Mahony, A. L., Brooks, D. J., Bisaga, A., Dakwar, E., Carpenter, K. M., Naqvi, N., Nunes, E. V., & Kampman, K.
Affiliations: New York State Psychiatric Institute (US)
University of Pennsylvania (US)
Corresponding author: Levin, Frances R.
ORCID: Levin, Frances R.
Mariani, John J.
Choi, C. Jean
Mahony, Amy L.
Bisaga, Adam
Carpenter, Kenneth M.
Nunes, Edward V.
Kampman, Kyle
Venue: Drug and Alcohol Dependence
Publisher: Elsevier BV
Published: 2020-01
Volume: 206
Pages: 107700
ISSN: 0376-8716 (ISSN-L)
DOI: 10.1016/j.drugalcdep.2019.107700
PMC: PMC6980777
OpenAlex: W2984929742
Cited by: 54
References: 67
Citations by year: 2026: 5 · 2025: 6 · 2024: 9 · 2023: 9 · 2022: 9 · 2021: 9 · 2020: 6 · 2019: 1
FWCI: 4.76
Type: journal article
Language: en
Open access: green
europepmc.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Drug and Alcohol Dependence (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institute on Drug Abuse
Topics: Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
Keywords: cocaine dependence, topiramate, combination pharmacotherapy, cocaine abstinence, cardiac safety, outpatient care, proof of concept
MeSH terms: Topiramate, Amphetamines, Delayed-Action Preparations, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Salts, Treatment Outcome, Drug Monitoring, Cocaine-Related Disorders

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

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