Kyle M Kampman1, Kevin G Lynch2, Helen M Pettinati2, Kelly Spratt3, Michael R Wierzbicki4, Charles Dackis2, Charles P O'Brien2. 1. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA. Electronic address: kampman@upenn.edu. 2. Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, USA. 3. Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA. 4. Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.
Abstract
BACKGROUND:Modafinil is a medication approved for narcolepsy and shift work sleep disorder. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of cocaine dependence. Modafinil has reduced cocaine subjective effects and cocaine self-administration in human laboratory trials and has reduced cocaine use in cocaine dependent patients in some clinical trials. METHODS: This was an 8-week, double blind, placebo controlled clinical trial involving 94 cocaine dependent subjects. Subjects received 300mg of modafinil or identical placebo daily along with weekly individual therapy. The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine benzoylecgonine tests (UBT). Additional outcome measures included cocaine craving measured by the Brief Substance Craving Scale and global improvement measured by the Clinical Global Impression Scale (CGI). RESULTS: The odds ratio (OR) in favor of abstinence for modafinil vs. placebo was 2.54 (p=. 03) and modafinil-treated subjects were significantly more likely than placebo-treated subjects to be abstinent from cocaine during the last 3 weeks of the trial, 23% vs. 9%, χ(2)=3.9, p<.05. Modafinil treated subjects were more likely to report very low levels of cocaine craving intensity and duration on the Brief Substance Craving Scale (OR=2.04, p=.03 and OR 1.06, p=.03 respectively). Modafinil-treated subjects were also more likely than placebo-treated subjects to rate themselves as "very much improved" on the CGI (OR=2.69, p=.03). CONCLUSION:Modafinil may be an efficacious treatment for cocaine dependence.
RCT Entities:
BACKGROUND:Modafinil is a medication approved for narcolepsy and shift work sleep disorder. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of cocaine dependence. Modafinil has reduced cocaine subjective effects and cocaine self-administration in human laboratory trials and has reduced cocaine use in cocaine dependent patients in some clinical trials. METHODS: This was an 8-week, double blind, placebo controlled clinical trial involving 94 cocaine dependent subjects. Subjects received 300mg of modafinil or identical placebo daily along with weekly individual therapy. The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine benzoylecgonine tests (UBT). Additional outcome measures included cocaine craving measured by the Brief Substance Craving Scale and global improvement measured by the Clinical Global Impression Scale (CGI). RESULTS: The odds ratio (OR) in favor of abstinence for modafinil vs. placebo was 2.54 (p=. 03) and modafinil-treated subjects were significantly more likely than placebo-treated subjects to be abstinent from cocaine during the last 3 weeks of the trial, 23% vs. 9%, χ(2)=3.9, p<.05. Modafinil treated subjects were more likely to report very low levels of cocaine craving intensity and duration on the Brief Substance Craving Scale (OR=2.04, p=.03 and OR 1.06, p=.03 respectively). Modafinil-treated subjects were also more likely than placebo-treated subjects to rate themselves as "very much improved" on the CGI (OR=2.69, p=.03). CONCLUSION:Modafinil may be an efficacious treatment for cocaine dependence.
Authors: K M Kampman; A I Alterman; J R Volpicelli; I Maany; E S Muller; D D Luce; E M Mulholland; A F Jawad; G A Parikh; F D Mulvaney; R M Weinrieb; C P O'Brien Journal: Psychol Addict Behav Date: 2001-03
Authors: Nora D Volkow; Joanna S Fowler; Jean Logan; David Alexoff; Wei Zhu; Frank Telang; Gene-Jack Wang; Millard Jayne; Jacob M Hooker; Christopher Wong; Barbara Hubbard; Pauline Carter; Donald Warner; Payton King; Colleen Shea; Youwen Xu; Lisa Muench; Karen Apelskog-Torres Journal: JAMA Date: 2009-03-18 Impact factor: 56.272
Authors: D V Sheehan; Y Lecrubier; K H Sheehan; P Amorim; J Janavs; E Weiller; T Hergueta; R Baker; G C Dunbar Journal: J Clin Psychiatry Date: 1998 Impact factor: 4.384
Authors: Joy M Schmitz; Charles E Green; Angela L Stotts; Jan A Lindsay; Nuvan S Rathnayaka; John Grabowski; F Gerard Moeller Journal: Drug Alcohol Depend Date: 2014-01-03 Impact factor: 4.492
Authors: K M Kampman; J R Volpicelli; D E McGinnis; A I Alterman; R M Weinrieb; L D'Angelo; L E Epperson Journal: Addict Behav Date: 1998 Jul-Aug Impact factor: 3.913
Authors: Carl L Hart; Margaret Haney; Suzanne K Vosburg; Eric Rubin; Richard W Foltin Journal: Neuropsychopharmacology Date: 2007-06-13 Impact factor: 7.853
Authors: Joy M Schmitz; Nuvan Rathnayaka; Charles E Green; F Gerard Moeller; Anne E Dougherty; John Grabowski Journal: Front Psychiatry Date: 2012-08-30 Impact factor: 4.157
Authors: Joy M Schmitz; Angela L Stotts; Anka A Vujanovic; Michael F Weaver; Jin H Yoon; Jessica Vincent; Charles E Green Journal: Contemp Clin Trials Date: 2017-12-26 Impact factor: 2.226
Authors: Brendan J Tunstall; Chelsea P Ho; Jianjing Cao; Janaína C M Vendruscolo; Brooke E Schmeichel; Rachel D Slack; Gianluigi Tanda; Alexandra J Gadiano; Rana Rais; Barbara S Slusher; George F Koob; Amy H Newman; Leandro F Vendruscolo Journal: Neuropharmacology Date: 2017-12-05 Impact factor: 5.250
Authors: Peter T Morgan; Gustavo A Angarita; Sofija Canavan; Brian Pittman; Lindsay Oberleitner; Robert T Malison; Vahid Mohsenin; Sarah Hodges; Caroline Easton; Sherry McKee; Andrew Bessette; Erica Forselius Journal: Drug Alcohol Depend Date: 2016-01-08 Impact factor: 4.492