CoChat
Sign Up
Cited by 85Substance Abuse Treatment and OutcomesNeurotransmitter Receptor Influence on BehaviorOpioid Use Disorder Treatment

Extended-Release Mixed Amphetamine Salts and Topiramate for Cocaine Dependence: A Randomized Controlled Trial

Open access
Mariani, John J., Pavlicova, Martina, Bisaga, Adam, Nunes, Edward V., Brooks, Daniel J., Levin, Frances R.·2012·Biological Psychiatry
DOI 10.1016/j.biopsych.2012.05.032PMC PMC3648884
Open this paper in CoChat — free account

Abstract

Background Cocaine dependence is a substantial public health problem, yet there are no clearly effective medication treatments. Amphetamine and topiramate have both shown promise for the treatment of cocaine dependence in preclinical and early-stage clinical studies. Methods Eighty-one cocaine-dependent adults were randomized to receive a combination of extended-release mixed amphetamine salts (MAS-ER) and topiramate or placebo for 12 weeks under double-blind conditions. MAS-ER doses were titrated over 2 weeks to a maximum dose of 60 mg daily, and topiramate doses were titrated over 6 weeks to a maximum dose of 150 mg twice daily. All participants received a supportive behavioral intervention. The primary outcome was the proportion of individuals who achieved 3 consecutive weeks of abstinence as measured by urine toxicology confirmed self-report. Results The overall proportion of participants who achieved 3 consecutive weeks of abstinence was larger in the extended-release mixed amphetamine salts and topiramate group (33.3%) than in placebo group (16.7%). There was a significant moderating effect of baseline total number of cocaine use days (Wald χ(2) = 3.75, df = 1, p = .05) on outcome, suggesting that the combination treatment was most effective for participants with a high baseline frequency of cocaine use. Conclusions The results of this study supported our hypothesis that the combination of MAS-ER and topiramate would be superior to placebo in achieving 3 weeks of consecutive abstinence. These findings provide evidence that the combination of MAS-ER and topiramate is efficacious in promoting abstinence in cocaine-dependent individuals.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.biopsych.2012.05.032

Cites

11 of 11 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • Individuals with substance use disorder are at significantly greater risk of overdose upon reentry, so continuity of care is critical during this vulnerable period.

    “Individuals with SUD are at a significantly greater risk of overdose upon reentry; therefore, continuity of care is critical during this vulnerable period.229”

    From The ASAM/AAAP Clinical Practice Guideline on the Management of Stimulant Use Disorder (2024) · cites this paper as [229]

    The Methods and Materials > Treatment passage describes adherence support during a cocaine-dependence trial, and the Discussion addresses treatment outcomes. Searches for overdose upon reentry and continuity of care after reentry found no passage addressing either point; no page numbers were available in our copy. (LLM, conf=0.75)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 31

  1. [4]de Lima MS de Oliveira Soares BG Reisser AA Farrell M Pharmacological treatment of cocaine dependence: a systematic review Addiction 2002 97 8 931 49 12144591
  2. [5]Leiderman DB Shoptaw S Montgomery A Bloch DA Elkashef A LoCastro J Cocaine Rapid Efficacy Screening Trial (CREST): a paradigm for the controlled evaluation of candidate medications for cocaine dependence Addiction 2005 100 Suppl 1 1 11 15773068
  3. [6]Karila L Gorelick D Weinstein A Noble F Benyamina A Coscas S New treatments for cocaine dependence: a focused review Int J Neuropsychopharmacol 2008 11 3 425 38 17927843
  4. [7]White FJ Kalivas PW Neuroadaptations involved in amphetamine and cocaine addiction Drug Alcohol Depend 1998 51 1–2 141 53 9716936
  5. [9]Berrettini WH Lerman CE Pharmacotherapy and pharmacogenetics of nicotine dependence Am J Psychiatry 2005 162 8 1441 51 16055765
  6. [10]Martinez D Carpenter KM Liu F Slifstein M Broft A Friedman AC Imaging Dopamine Transmission in Cocaine Dependence: Link Between Neurochemistry and Response to Treatment Am J Psychiatry 2011 PMC3235735 21406463
  7. [11]Schubiner H Saules KK Arfken CL Johanson CE Schuster CR Lockhart N Double-blind placebo-controlled trial of methylphenidate in the treatment of adult ADHD patients with comorbid cocaine dependence Exp Clin Psychopharmacol 2002 10 3 286 94 12233989
  8. [13]Grabowski J Roache JD Schmitz JM Rhoades H Creson D Korszun A Replacement medication for cocaine dependence: methylphenidate J Clin Psychopharmacol 1997 17 6 485 8 9408812
  9. [15]Shearer J Wodak A van Beek I Mattick RP Lewis J Pilot randomized double blind placebo-controlled study of dexamphetamine for cocaine dependence Addiction 2003 98 8 1137 41 12873248
  10. [17]Poling J Oliveto A Petry N Sofuoglu M Gonsai K Gonzalez G Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained population Arch Gen Psychiatry 2006 63 2 219 28 16461866
  11. [20]Castells X Casas M Perez-Mana C Roncero C Vidal X Capella D Efficacy of psychostimulant drugs for cocaine dependence Cochrane Database Syst Rev 2010 2 CD007380 20166094
  12. [21]Sofuoglu M Dudish-Poulsen S Poling J Mooney M Hatsukami DK The effect of individual cocaine withdrawal symptoms on outcomes in cocaine users Addict Behav 2005 30 6 1125 34 15925122
  13. [22]Alvarez Y Farre M Fonseca F Torrens M Anticonvulsant drugs in cocaine dependence: a systematic review and meta-analysis J Subst Abuse Treat 2010 38 1 66 73 19717271
  14. [23]Kampman KM Pettinati H Lynch KG Dackis C Sparkman T Weigley C A pilot trial of topiramate for the treatment of cocaine dependence Drug Alcohol Depend 2004 75 3 233 40 15283944
  15. [24]Brodie JD Case BG Figueroa E Dewey SL Robinson JA Wanderling JA Randomized, double-blind, placebo-controlled trial of vigabatrin for the treatment of cocaine dependence in Mexican parolees Am J Psychiatry 2009 166 11 1269 77 19651710
  16. [25]White HS Brown SD Woodhead JH Skeen GA Wolf HH Topiramate modulates GABA-evoked currents in murine cortical neurons by a nonbenzodiazepine mechanism Epilepsia 2000 41 Suppl 1 S17 20 10768294
  17. [26]Skradski S White HS Topiramate blocks kainate-evoked cobalt influx into cultured neurons Epilepsia 2000 41 Suppl 1 S45 7 10768300
  18. [27]Johnson BA Ait-Daoud N Bowden CL DiClemente CC Roache JD Lawson K Oral topiramate for treatment of alcohol dependence: a randomised controlled trial Lancet 2003 361 9370 1677 85 12767733
  19. [28]Johnson BA Rosenthal N Capece JA Wiegand F Mao L Beyers K Topiramate for treating alcohol dependence: a randomized controlled trial Jama 2007 298 14 1641 51 17925516
  20. [29]Johnson BA Ait-Daoud N Akhtar FZ Javors MA Use of oral topiramate to promote smoking abstinence among alcohol-dependent smokers: a randomized controlled trial Arch Intern Med 2005 165 14 1600 5 16043677
  21. [30]Johnson BA Swift RM Addolorato G Ciraulo DA Myrick H Safety and efficacy of GABAergic medications for treating alcoholism Alcohol Clin Exp Res 2005 29 2 248 54 15714047
  22. [31]Johnson BA Swift RM Ait-Daoud N DiClemente CC Javors MA Malcolm RJ Jr Development of novel pharmacotherapies for the treatment of alcohol dependence: focus on antiepileptics Alcohol Clin Exp Res 2004 28 2 295 301 15112937
  23. [32]Schiffer WK Gerasimov MR Marsteller DA Geiger J Barnett C Alexoff DL Topiramate selectively attenuates nicotine-induced increases in monoamine release Synapse 2001 42 3 196 8 11746717
  24. [33]Nies AS Principles of Therapeutics 10 Goodman and Gilman’s the pharmacological basis of therapeutics Hardman JG Limbard EL Gilman AG 2001 New York The McGraw-Hill Companies, Inc 54
  25. [34]Carroll KM Rounsaville BJ Nich C Gordon LT Wirtz PW Gawin F One-year follow-up of psychotherapy and pharmacotherapy for cocaine dependence. Delayed emergence of psychotherapy effects Arch Gen Psychiatry 1994 51 12 989 97 7979888
  26. [37]First MB Spitzer RL Gibbon M Williams JBW Structured Clinical Interview for DSM-IV Axis I Disorders- Patient Edition (SCID-I/P, Version 2.0) 1995 Biometrics Research Department, New York State Psychiatric Institute
  27. [38]Litten R Allen J Measuring Alcohol Consumption: Psychosocial and Biochemical Methods 1992 Totowa, NJ The Humana Press Inc 41 72
  28. [42]Bisaga A Aharonovich E Garawi F Levin FR Rubin E Raby WN Utility of lead-in period in cocaine dependence pharmacotherapy trials Drug Alcohol Depend 2005 77 1 7 11 15607836
  29. [43]Kampman KM Volpicelli JR Mulvaney F Rukstalis M Alterman AI Pettinati H Cocaine withdrawal severity and urine toxicology results from treatment entry predict outcome in medication trials for cocaine dependence Addict Behav 2002 27 2 251 60 11817766
  30. [44]Johnson BA Roache JD Ait-Daoud N Wells LT Wallace CL Dawes MA Effects of acute topiramate dosing on methamphetamine-induced subjective mood Int J Neuropsychopharmacol 2007 10 1 85 98 16448579
  31. [45]Anton RF O’Malley SS Ciraulo DA Cisler RA Couper D Donovan DM Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial Jama 2006 295 17 2003 17 16670409

Cited by

Sorted by citations

Authors
Mariani, J. J., Pavlicova, M., Bisaga, A., Nunes, E. V., Brooks, D. J., & Levin, F. R.
Affiliations
New York State Psychiatric Institute (US)
Corresponding author
Levin, Frances R.
ORCID
Venue
Biological Psychiatry
Publisher
Elsevier BV
Published
2012-12
Volume
72
Issue
11
Pages
950-956
ISSN
0006-3223 (ISSN-L)
DOI
10.1016/j.biopsych.2012.05.032
PMC
PMC3648884
OpenAlex
W2056120061
Cited by
85
References
11
Citations by year
2026: 3 · 2025: 4 · 2024: 6 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 5 · 2019: 5 · 2018: 5 · 2017: 5 · 2016: 7 · 2015: 12 · 2014: 13 · 2013: 8 · 2012: 1
FWCI
8.14
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Biological Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute on Drug Abuse (R01 DA022217, K23 DA021209, K24 029647, K24 DA022412)
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, medication-assisted treatment
MeSH terms
Topiramate, Adolescent, Adult, Amphetamine, Delayed-Action Preparations, Double-Blind Method, Drug Combinations, Female, Fructose, Humans, Male, Middle Aged, Treatment Outcome, Cocaine-Related Disorders, Self Report

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review