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Experience in developing a tool using the CSSA as a model

Experience in developing a tool using the CSSA as a model. Kyle M. Kampman M.D. Professor Department of Psychiatry Perelman School of Medicine University of Pennsylvania MOST Meeting 25 March 2015. Developing the CSSA as an outcome measure. What is the CSSA? Where did it come from ?

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Experience in developing a tool using the CSSA as a model

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  1. Experience in developing a tool using the CSSA as a model Kyle M. Kampman M.D. Professor Department of Psychiatry Perelman School of Medicine University of Pennsylvania MOST Meeting 25 March 2015

  2. Developing the CSSA as an outcome measure • What is the CSSA? • Where did it come from? • What does it measure? • Basic reliability and validity testing • Subsequent testing and usefulness in clinical trials

  3. What is the CSSA? Cocaine Selective Severity Assessment • - It is a measure of cocaine withdrawal • - 18 Item each measured on a 0-7 scale • - Signs and symptoms measured include: • appetite changes sleep changes • cocaine craving depressed mood • anxiety irritability • lethargy inattention • paranoia heart rate changes

  4. Where did the CSSA come from? • CSSA written by Joe Volpicelli at Penn CSA • Modeled on the Selective Severity Assessment for alcohol (Gross 1973) • Intended to assist in the management of cocaine withdrawal syndrome

  5. Cocaine withdrawal as a syndrome Gawin and Kleber Arch Gen Psychiatry 1986;43:107-113

  6. Cocaine withdrawal and subjective effects Cocaine Withdrawal Increases the Cocaine High • Depression increases cocaine high • (Uslaner, 1999; Sofuoglu, 2001) • Irritability increases cocaine high • (Newton, 2003)

  7. Cocaine withdrawal and subjective effects Cocaine Withdrawal Increases the Cocaine High Sofuoglu et al. Drug Alcohol Depend 2003; 69:273-282

  8. Cocaine withdrawal and hedonic dysregulation Several studies report that the presence of severe cocaine withdrawal symptoms at baseline predicts poor clinical outcome Craving Hedonic Dysregulation Is cocaine withdrawal just the tip of the iceberg? WD

  9. The CSSA 18 Items Interviewer administered 2 craving scales One total score

  10. Psychometric testing • Initial reliability and validity testing • Test retest reliability • Interrater reliability • Internal consistency • Concurrent validity • Predictive validity Kampman et al. Addict Behav. 1998 (4):449-61.

  11. CSSA: concurrent validity • Individual items correlate with DSM-IV criteria • Depressed mood • Lethargy • Increased appetite • Increased sleep • Irritability

  12. CSSA: concurrent validity • Individual items correlate with ASI severity measures • More days of cocaine use • Longer lifetime history of cocaine use • Higher ASI Severity scores for drug problems

  13. CSSA: concurrent validity • Specific to cocaine withdrawal

  14. CSSA: concurrent validity • Scores decline over time if a patient becomes abstinent

  15. CSSA: predictive validity High CSSA Scores Predict Poor Outcome 1. Psychotherapy trial, University of Pennsylvania Completed 30 Days of Treatment * * p = .005 Mulvaney et al., JSAT 1999;16(2):129-35.

  16. CSSA: predictive validity High CSSA Scores Predict Poor Outcome 2. Day Hospital, Philadelphia VAMC Completed 30 Days of Treatment * *p = .001 Kampman et al. Psychol Addict Behav. 2001;15(1):52-9.

  17. CSSA : predictive validity High CSSA Scores Predict Poor Outcome 3. Medication Trial, University of Pennsylvania 3 Consecutive Weeks of Abstinence * * p < .001 Kampman et al., Addict Behav. 2002;27(2):251-60.

  18. Identifying predictors in cocaine dependence treatment Subjects and measures • 7 clinical trials 7-12 weeks duration • Cocaine dependent only • ASI, UDS 2-3 weekly, TLFB self-report Predictor variables • Baseline ASI • Baseline UDS • CSSA scores Outcome variables • Three weeks of continuous abstinence • 50% reduction ASI Composite Drug Score • No self reported cocaine use last 4 wks of the trial

  19. Demographics and baseline drug use data N 402 Age 39 (6.8) % African-American 81% % men 75% Years of education 13 (1.9) % crack smokers 87% Days coc. use (past 30) 13 (9.3) Years coc. Use (lifetime) 9.9 (6.0) $ for drugs (past 30) $606 (850) ASI Comp. Drug Score .230 (.08) CSSA score 27 (18) (standard deviation)

  20. Baseline predictors . Bough et al. Neuropsychopharmacology. 2014;39(1):202-19

  21. CSSA and medication response: amantadine Amantadine Improved Abstinence Number of Clean Urine Samples 6 5 4 3 2 1 0 Low CSSA High CSSA Amantadine Placebo Kampman et al., Am J Psychiatry. 2000;157(12):2052-4.

  22. CSSA and medication response: propranolol Propranolol Improves Outcome in High CSSA Patients Retention Urinary BE Levels Kampman et al., Drug Alcohol Depend. 2001;63(1):69-78.

  23. CSSA and medication response; topiramate Kampman et al. Drug Alcohol Depend. 2013;133(1):94-9.

  24. CSSA as an outcome measure CSSA Scores in Treatment Mean CSSA scores tend to decline over time in medication trials No differences in CSSA scores over time in several trials topiramate modafinil acamprosate naltrexone (oral) naltrexone (extended release injectable) varenicline piracetam disulfiram olanzapine ginko biloba theobromine amantadine *propranolol – reduced withdrawal symptoms in 1st trial not 2nd

  25. Discussion • The CSSA is an good predictor of outcome in outpatient cocaine dependence treatment • The CSSA may identify subgroups responsive to particular medications – propranolol and topiramate for example • No medication tested has shown a differential response in reducing CSSA scores.

  26. Individual CSSA Items as Predictors . Cocaine craving and bradycardia were the most consistent predictors of outcome.

  27. Predictors of psychosocial treatment outcome High CSSA Scores Predict Poor Outcome Retention Outpatient N=87 Retention Day Program N=97 Abstinence Med Trial N=76 Abstinence Coc/alc N= 80

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