experience in developing a tool using the cssa as a model kyle m. kampman m.d. professor department...
TRANSCRIPT
Experience in developing a tool using the CSSA as a model
Kyle M. Kampman M.D.Kyle M. Kampman M.D.
Professor Professor
Department of PsychiatryDepartment of Psychiatry
Perelman School of MedicinePerelman School of Medicine
University of Pennsylvania University of Pennsylvania
MOST Meeting 25 March 2015MOST Meeting 25 March 2015
Developing the CSSA as an outcome measureDeveloping the CSSA as an outcome measure
• What is the CSSA?What is the CSSA?
• Where did it come from?Where did it come from?
• What does it measure?What does it measure?
• Basic reliability and validity testingBasic reliability and validity testing
• Subsequent testing and usefulness in clinical trialsSubsequent testing and usefulness in clinical trials
What is the CSSA?What is the CSSA?
CCocaine ocaine SSelective elective SSeverity everity AAssessmentssessment
- It is a measure of cocaine withdrawal- It is a measure of cocaine withdrawal
- 18 Item each measured on a 0-7 scale- 18 Item each measured on a 0-7 scale
- Signs and symptoms measured include:- Signs and symptoms measured include:
appetite changesappetite changes sleep changessleep changes
cocaine cravingcocaine craving depressed mooddepressed mood
anxietyanxiety irritability irritability
lethargylethargy inattention inattention
paranoiaparanoia heart rate changes heart rate changes
Where did the CSSA come from?Where did the CSSA come from?
• CSSA written by Joe Volpicelli at Penn CSACSSA written by Joe Volpicelli at Penn CSA
• Modeled on the Selective Severity Assessment Modeled on the Selective Severity Assessment for alcohol (Gross 1973)for alcohol (Gross 1973)
• Intended to assist in the management of Intended to assist in the management of cocaine withdrawal syndrome cocaine withdrawal syndrome
Cocaine withdrawal as a syndrome
Gawin and Kleber Arch Gen Psychiatry 1986;43:107-113
Cocaine withdrawal and subjective effects
• Depression increases cocaine high(Uslaner, 1999; Sofuoglu, 2001)
• Irritability increases cocaine high(Newton, 2003)
Cocaine Withdrawal Increases the Cocaine High
Cocaine withdrawal and subjective effects
Cocaine Withdrawal Increases the Cocaine High
Sofuoglu et al. Drug Alcohol Depend 2003; 69:273-282
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
WD
The CSSA
18 Items
Interviewer administered
2 craving scales
One total score
Psychometric testingPsychometric testing
Initial reliability and validity testingInitial reliability and validity testing
1.1. Test retest reliabilityTest retest reliability
2.2. Interrater reliability Interrater reliability
3.3. Internal consistencyInternal consistency
4. Concurrent validity
5. Predictive validity
Kampman et al. Addict Behav. 1998 (4):449-61.
CSSA: concurrent validityCSSA: concurrent validity
Individual items correlate with DSM-IV criteriaIndividual items correlate with DSM-IV criteria
•Depressed moodDepressed mood
•LethargyLethargy
•Increased appetiteIncreased appetite
•Increased sleepIncreased sleep
•Irritability Irritability
CSSA: concurrent validityCSSA: concurrent validity
Individual items correlate with ASI severity measuresIndividual items correlate with ASI severity measures
–More days of cocaine useMore days of cocaine use
–Longer lifetime history of cocaine useLonger lifetime history of cocaine use
–Higher ASI Severity scores for drug problemsHigher ASI Severity scores for drug problems
CSSA: concurrent validityCSSA: concurrent validity
Specific to cocaine withdrawalSpecific to cocaine withdrawal
CSSA: concurrent validityCSSA: concurrent validity
Scores decline over time if a patient becomes abstinentScores decline over time if a patient becomes abstinent
CSSA: predictive validityCSSA: predictive validity
High CSSA Scores Predict Poor OutcomeHigh CSSA Scores Predict Poor Outcome1. Psychotherapy trial, University of Pennsylvania
Completed 30 Days of Treatment
Mulvaney et al., JSAT 1999;16(2):129-35.
*
* p = .005
CSSA: predictive validityCSSA: predictive validity
High CSSA Scores Predict Poor OutcomeHigh CSSA Scores Predict Poor Outcome2. Day Hospital, Philadelphia VAMC
Completed 30 Days of Treatment
Kampman et al. Psychol Addict Behav. 2001;15(1):52-9.
*
*p = .001
CSSA : predictive validityCSSA : predictive validity
High CSSA Scores Predict Poor OutcomeHigh CSSA Scores Predict Poor Outcome3. Medication Trial, University of Pennsylvania
3 Consecutive Weeks of Abstinence
Kampman et al., Addict Behav. 2002;27(2):251-60.
*
* p < .001
Identifying predictors in cocaine dependence treatmentIdentifying 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
Demographics and baseline drug use dataDemographics and baseline drug use data
N N 402 402Age Age 39 (6.8) 39 (6.8)% African-American % African-American 81% 81%% men % men 75% 75%Years of educationYears of education 13 (1.9) 13 (1.9)% crack smokers % crack smokers 87% 87%Days coc. use (past 30) Days coc. use (past 30) 13 (9.3) 13 (9.3)Years coc. Use (lifetime) 9.9 (6.0)Years coc. Use (lifetime) 9.9 (6.0)$ for drugs (past 30) $ for drugs (past 30) $606 (850) $606 (850)ASI Comp. Drug Score ASI Comp. Drug Score .230 (.08) .230 (.08)CSSA scoreCSSA score 27 (18) 27 (18)
(standard deviation)
Baseline predictors Baseline predictors
.3 Weeks of Continuous
Cocaine Abstinence
Model 2 (P)
50% Reduction in ASI Composite Drug
Scores Model 2 (P)
Self-Reported Abstinence, Last 4
Weeks of Treatment Model 2 (P)
Age 4.1 .04 2.3 .13 .60 .44
Gender .80 .37 <.01 .99 .01 .91
Yrs education .89 .35 4.2 .04 .77 .38
Days coc. Use (past 30) 24.6 <.001 3.4 .06 21.5 <.001
Yrs coc use (lifetime) 1.2 .27 .07 .79 2.1 .14
Days alc. Use (past 30) .05 .82 3.2 .07 <.01 .99
Yrs alc use (lifetime) 3.3 .07 6.3 .01 4.1 .04
Initial UDS 23.9 <.001 8.1 .004 14.0 <.001
Initial CSSA score 16.5 <.001 8.4 .004 15.5 <.001
Bough et al. Neuropsychopharmacology. 2014;39(1):202-19
0
1
2
3
4
5
6
Low CSSA High CSSA
Amantadine Placebo
Number of Clean Urine Samples
CSSA and medication response: amantadineCSSA and medication response: amantadine
Amantadine Improved AbstinenceAmantadine Improved Abstinence
Kampman et al., Kampman et al., Am J Psychiatry. 2000;157(12):2052-4.Am J Psychiatry. 2000;157(12):2052-4.
CSSA and medication response: propranololCSSA and medication response: propranolol
Propranolol Improves Outcome in High CSSA PatientsPropranolol Improves Outcome in High CSSA Patients
RetentionRetention Urinary BE LevelsUrinary BE Levels
Kampman et al., Drug Alcohol Depend. 2001;63(1):69-78.
CSSA and medication response; topiramateCSSA and medication response; topiramate
Kampman et al. Drug Alcohol Depend. 2013;133(1):94-9.
CSSA as an outcome measureCSSA as an outcome measure
CSSA Scores in Treatment CSSA Scores in Treatment Mean CSSA scores tend to decline over time in medication trials
No differences in CSSA scores over time in several trialstopiramatemodafinilacamprosatenaltrexone (oral)naltrexone (extended release injectable)vareniclinepiracetamdisulfiramolanzapineginko bilobatheobromineamantadine*propranolol – reduced withdrawal symptoms in 1st trial not 2nd
DiscussionDiscussion
• The CSSA is an good predictor of outcome in outpatient The CSSA is an good predictor of outcome in outpatient cocaine dependence treatmentcocaine dependence treatment
• The CSSA may identify subgroups responsive to particular The CSSA may identify subgroups responsive to particular medications – propranolol and topiramate for examplemedications – propranolol and topiramate for example
• No medication tested has shown a differential response in No medication tested has shown a differential response in reducing CSSA scores.reducing CSSA scores.
Individual CSSA Items as PredictorsIndividual CSSA Items as Predictors
.3 Weeks of Continuous
Cocaine Abstinence
Model 2 (P)
50% Reduction in ASI Comp. Drug
Scores
Model 2 (P)
Self-Reported Abstinence, Last 4
Weeks of Treatment
Model 2 (P)
Hyperphagia .18 .66 .27 .59 .17 .68
Hypophagia 2.1 .14 1.3 .25 .3.6 .06
Carb. Craving 5.6 .02 .01 .93 ..40 .52
Coc. Crav. intensity 22.0 <.001 6.7 .009 17.6 <.001
Coc. Crav. frequency 17.0 <.001 4.7 .03 9.1 .003
Bradycardia 11.6 .001 3.5 .04 9.0 .003
Decreased Sleep 1.8 .18 .48 ..48 4.4 .04
Increased sleep 5.3 .02 .67 .412 4.3 .03
Anxiety .05 .83 4.0 .04 .19 .66
Cocaine craving and bradycardia were the most consistent predictors of outcome.
Predictors of psychosocial treatment outcomePredictors of psychosocial treatment outcome
RetentionOutpatient
N=87
RetentionDay Program
N=97
AbstinenceMed Trial
N=76
High CSSA Scores Predict Poor OutcomeHigh CSSA Scores Predict Poor Outcome
AbstinenceCoc/alcN= 80