Assessment concordance and predictive validity of self-report and biological assay of cocaine use in treatment trials.

BACKGROUND AND OBJECTIVES Cocaine use during randomized clinical trials (RCTs) is typically assessed by participant self-report or biological assay (eg, urinalysis). There have been few direct comparisons of these assessment methods to investigate their concordance and their predictive validity for cocaine use and psychosocial outcomes following treatment completion. METHOD In a combined sample of 380 participants from 5 cocaine RCTs, the concordance between cocaine use assessment methods was examined. Sequential multiple linear and logistic regression models evaluated the predictive validity of two assessment methods for cocaine use and psychosocial outcomes assessed at 1, 3, 6, and 12 months after treatment. RESULTS Concordance for self-report and urinalysis indicators of cocaine use was high within-treatment (k = 0.72) and moderate during follow-up (k = 0.51). Rates of concordance were higher in studies using test cups with immediate urinalysis results. Regression analyses indicated that self-report data within-treatment predicted self-reported cocaine use at all post-treatment points (β 0.22-0.30, p < .01), while urinalysis results within-treatment predicted urinalysis results at 1, 3, and 6 months post-treatment (OR 3.92-20.99, p < .05). Cocaine-positive urinalyses within-treatment were negatively associated with a composite "good outcome" indicator at 1 and 3 months post-treatment (OR 0.17-0.32, p < .05). DISCUSSION AND CONCLUSIONS These results suggest a significant role of method variance in predicting post-treatment outcomes from within-treatment cocaine use indices. SCIENTIFIC SIGNIFICANCE Results support recommendations that cocaine treatment trials should include both biological assay and self-report assessment. Test cups may facilitate increased self-report accuracy.

[1]  B. Quednow,et al.  Cognitive dysfunctions in recreational and dependent cocaine users: role of attention-deficit hyperactivity disorder, craving and early age at onset , 2013, British Journal of Psychiatry.

[2]  K. Carroll,et al.  Efficacy of disulfiram and Twelve Step Facilitation in cocaine-dependent individuals maintained on methadone: a randomized placebo-controlled trial. , 2012, Drug and alcohol dependence.

[3]  G. Marlatt,et al.  Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end-points in clinical trials. , 2012, Addiction.

[4]  E. Cone Oral fluid results compared to self reports of recent cocaine and heroin use by methadone maintenance patients. , 2012, Forensic science international.

[5]  O. García-Rodríguez,et al.  Individual characteristics and response to Contingency Management treatment for cocaine addiction. , 2011, Psicothema.

[6]  Megan S. Schuler,et al.  Temporal and Gender Trends in Concordance of Urine Drug Screens and Self-Reported Use in Cocaine Treatment Studies , 2009, Journal of addiction medicine.

[7]  G. Reisfield,et al.  'False-positive' and 'false-negative' test results in clinical urine drug testing. , 2009, Bioanalysis.

[8]  B. Rounsaville,et al.  Computer-assisted delivery of cognitive-behavioral therapy for addiction: a randomized trial of CBT4CBT. , 2008, The American journal of psychiatry.

[9]  M. Huestis,et al.  Cocaine and metabolites urinary excretion after controlled smoked administration. , 2007, Journal of analytical toxicology.

[10]  T. Killeen,et al.  Effect of prize-based incentives on outcomes in stimulant abusers in outpatient psychosocial treatment programs: a national drug abuse treatment clinical trials network study. , 2005, Archives of general psychiatry.

[11]  M. Huestis,et al.  Dose-Related Distribution of Codeine, Cocaine, and Metabolites into Human Hair following Controlled Oral Codeine and Subcutaneous Cocaine Administration , 2005, Journal of Pharmacology and Experimental Therapeutics.

[12]  B. Rounsaville,et al.  Efficacy of disulfiram and cognitive behavior therapy in cocaine-dependent outpatients: a randomized placebo-controlled trial. , 2004, Archives of general psychiatry.

[13]  R. Rawson,et al.  Predicting treatment success at multiple timepoints in diverse patient populations of cocaine-dependent individuals. , 2002, Drug and alcohol dependence.

[14]  J. McKay,et al.  A Review of Temporal Effects and Outcome Predictors in Substance Abuse Treatment Studies With Long-Term Follow-Ups , 2001, Evaluation review.

[15]  J. McKay,et al.  Continuous, categorical, and time to event cocaine use outcome variables: degree of intercorrelation and sensitivity to treatment group differences. , 2001, Drug and alcohol dependence.

[16]  L. Davis,et al.  Comparison of patient self-reports and urinalysis results obtained under naturalistic methadone treatment conditions. , 2000, Drug and alcohol dependence.

[17]  P. Rutigliano,et al.  The timeline followback reports of psychoactive substance use by drug-abusing patients: psychometric properties. , 2000, Journal of consulting and clinical psychology.

[18]  H. Kranzler,et al.  The validity of self-reported cocaine use in two groups of cocaine abusers. , 1999, Journal of consulting and clinical psychology.

[19]  R. Brooner,et al.  Cocaine use early in treatment predicts outcome in a behavioral treatment program. , 1998, Journal of consulting and clinical psychology.

[20]  K. Carroll,et al.  Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram. , 1998, Addiction.

[21]  K. Carroll,et al.  Psychotherapeutic considerations in pharmacological trials. , 1996, Alcoholism, clinical and experimental research.

[22]  M. Engle,et al.  Validity of self-reported crack cocaine use among homeless persons in treatment. , 1995, Journal of substance abuse treatment.

[23]  G. Woody,et al.  Similarity of outcome predictors across opiate, cocaine, and alcohol treatments: role of treatment services. , 1994, Journal of consulting and clinical psychology.

[24]  A. Mclellan,et al.  Can you trust patient self-reports of drug use during treatment? , 1994, Drug and alcohol dependence.

[25]  D. Metzger,et al.  The Fifth Edition of the Addiction Severity Index. , 1992, Journal of substance abuse treatment.

[26]  F. J. Evans,et al.  New Data from the Addiction Severity Index Reliability and Validity in Three Centers , 1985, The Journal of nervous and mental disease.

[27]  J. Fleiss,et al.  Statistical methods for rates and proportions , 1973 .

[28]  F. D. Del Boca,et al.  Talk is cheap: measuring drinking outcomes in clinical trials. , 2000, Journal of studies on alcohol.

[29]  M. Hiller,et al.  The validity of self-reported cocaine use in a criminal justice treatment sample. , 1998, The American journal of drug and alcohol abuse.

[30]  B. Tai Appendix I : Workshop Summary Outcome Measures and Success Criteria , 1998 .

[31]  P. Bridge,et al.  Medication Development for the Treatment of Cocaine Dependence: Issues in Clinical Efficacy Trials : (NIDA Research Monograph ; 175) , 1997 .

[32]  L Harrison,et al.  Introduction--the validity of self-reported drug use: improving the accuracy of survey estimates. , 1997, NIDA research monograph.

[33]  E. Cone New developments in biological measures of drug prevalence. , 1997, NIDA research monograph.

[34]  Linda C. Sobell,et al.  Timeline Follow-Back A Technique for Assessing Self-Reported Alcohol Consumption , 1992 .

[35]  B. Rounsaville,et al.  Interpersonal psychotherapy adapted for ambulatory cocaine abusers. , 1985, The American journal of drug and alcohol abuse.