Determining the primary endpoint for a stimulant abuse trial: Lessons learned from STRIDE (CTN 0037)

American Journal of Drug and Alcohol Abuse

Volumn 37, Issue 5, 2011, Pages 339-349

  Trivedi, Madhukar H ^a   Greer, Tracy L ^a   Potter, Jennifer Sharpe ^b   Grannemann, Bruce D ^a   Nunes, Edward V ^c   Rethorst, Chad ^a   Warden, Diane ^a   Ring, Kolette M ^a   Somoza, Eugene ^d,e  

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^c NEW YORK STATE PSYCHIATRIC INSTITUTE   (United States)

^d VETERANS AFFAIRS MEDICAL CENTER   (United States)

^e UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

Author keywords

Cocaine abuse; Endpoint; Exercise; Measurement; Stimulant abuse

Indexed keywords

ADDICTION SEVERITY INDEX LITE; ARTICLE; BIOASSAY; CLINICAL EFFECTIVENESS; DRUG DEPENDENCE TREATMENT; HAIR ANALYSIS; HUMAN; INTERVIEW; NON INVASIVE MEASUREMENT; OUTCOME ASSESSMENT; QUALITATIVE ANALYSIS; SELF REPORT; SUBSTANCE ABUSE; SUBSTANCE USE DIARY; SWEAT TEST; TIME LINE FOLLOW BACK; URINE DRUG SCREEN;

ENDPOINT DETERMINATION; EXERCISE THERAPY; HUMANS; NATIONAL INSTITUTE ON DRUG ABUSE (U.S.); RESEARCH DESIGN; SUBSTANCE ABUSE DETECTION; SUBSTANCE-RELATED DISORDERS; UNITED STATES;

EID: 80052235784     PISSN: 00952990     EISSN: 10979891     Source Type: Journal    
DOI: 10.3109/00952990.2011.598589     Document Type: Article

References (46)

1. Dutra L, Stathopoulou G, Basden SL, Leyro TM, Powers MB, Otto MW. A meta-analytic review of psychosocial interventions for substance use disorders. Am J Psychiatry 2008; 165(2):179-187. (Pubitemid 351704516)
2. Carroll KM, Ball SA, Nich C, Martino S, Frankforter TL, Farentinos C, Kunkel LE, Mikulich-Gilbertson SK, Morgenstern J, Obert JL, Polcin D, Snead N, Woody GE. Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: A multisite effectiveness study. Drug Alcohol Depend 2006; 81(3):301-312. (Pubitemid 43152457)
3. Rawson RA,McCannMJ, Flammino F, Shoptaw S, Miotto K, Reiber C, Ling W. A comparison of contingency management and cognitive-behavioral approaches for stimulant-dependent individuals. Addiction 2006; 101(2):267-274. (Pubitemid 43351600)
4. Wetzel H, Szegedi A, Scheurich A, Lorch B, Singer P, Schlafke D, Sittinger H, Wobrock T, Muller MJ, Anghelescu I, Hautzinger M. Combination treatment with nefazodone and cognitive-behavioral therapy for relapse prevention in alcohol-dependent men: A randomized controlled study. J Clin Psychiatry 2004; 65(10):1406-1413.
5. Ball SA, Martino S, Nich C, Frankforter TL, Van Horn D, Crits-Christoph P,Woody GE, Obert JL, Farentinos C, Carroll KM. Site matters: Multisite randomized trial of motivational enhancement therapy in community drug abuse clinics. J Consult Clin Psychol 2007; 75(4):556-567. (Pubitemid 47454576)
6. Fals-Stewart W, OFarrell TJ, Freitas TT, McFarlin SK, Rutigliano P. The timeline followback reports of psychoactive substance use by drug-abusing patients: Psychometric properties. J Consult Clin Psychol 2000; 68(1):134-144. (Pubitemid 30120958)
7. Preston KL, Silverman K, Schuster CR, Cone EJ. Assessment of cocaine use with quantitative urinalysis and estimation of new uses. Addiction 1997; 92(6):717-727. (Pubitemid 27267801)
8. Gerstein DR. Outcome research - drug abuse. In American Psychiatric Press Textbook of Substance Abuse Treatment. Galanter M, Kleber HD, eds. Washington, DC: American Psychiatric Press, 1999.
9. Lavori PW, Bloch DA, Bridge PT, Leiderman DB, LoCastro JS, Somoza E. Plans, designs, and analyses for clinical trials of anti-cocaine medications: Where we are today. NIDA/VA/SU Working Group on Design and Analysis. J Clin Psychopharmacol 1999; 19(3):246-256. (Pubitemid 29233019)
10. Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: Issues and recommendations. Nicotine Tob Res 2003; 5(1): 13-25. (Pubitemid 36285465)
11. Higgins ST, Budney AJ, Bickel WK, Hughes JR, Foerg F, Badger G. Achieving cocaine abstinence with a behavioral approach. Am J Psychiatry 1993; 150(5):763-769. (Pubitemid 23137683)
12. Petry NM, Peirce JM, Stitzer ML, Blaine J, Roll JM, Cohen A, Obert J, Killeen T, SaladinME, CowellM, Kirby KC, Sterling R, Royer-Malvestuto C, Hamilton J, Booth RE, Macdonald M, Liebert M, Rader L, Burns R, DiMaria J, Copersino M, Stabile PQ, Kolodner K, Li R. Effect of prize-based incentives on outcomes in stimulant abusers in outpatient psychosocial treatment programs: A national drug abuse treatment clinical trials network study. Arch Gen Psychiatry 2005; 62(10): 1148-1156. (Pubitemid 41396940)
13. Allen JP. Measuring outcome in interventions for alcohol dependence and problem drinking: Executive summary of a conference sponsored by the national institute on alcohol abuse and alcoholism. Alcohol Clin Exp Res 2003; 27(10):1657-1660. (Pubitemid 37280748)
14. Anton RF, Randall CL. Measurement and choice of drinking outcome variables in the COMBINE study. J Stud Alcohol Drugs Suppl 2005; 15:104-109. (Pubitemid 41193184)
15. Babor TF, Steinberg K, Anton R, Del Boca F. Talk is cheap: Measuring drinking outcomes in clinical trials. J Stud Alcohol 2000; 61(1):55-63. (Pubitemid 30005059)
16. Del Boca F, Noll JA. Truth of consequences: The validity of self-report data in health services research on addictions. Addiction 2000; 95(Suppl. 3):S347-S360.
17. Finney JW, Moyer A, Swearingen CE, Variables O. Their assessment in alcohol treatment studies: 1968-1998. Alcohol Clin Exp Res 2003; 27(10):1671-1679. (Pubitemid 37280751)
18. Miller PG, Miller WR. What should we be aiming for in the treatment of addiction? Addiction 2009; 104:685-686.
19. Silverman K, Robles E, Mudric T, Bigelow GE, Stitzer ML. A randomized trial of long-term reinforcement of cocaine abstinence in methadone-maintained patients who inject drugs. J Consult Clin Psychol 2004; 72(5):839-854. (Pubitemid 39299446)
20. Silverman K, Higgins ST, Brooner RK, Montoya ID, Cone EJ, Schuster CR, Preston KL. Sustained cocaine abstinence in methadone maintenance patients through voucher-based reinforcement therapy. Arch Gen Psychiatry 1996; 53(5): 409-415. (Pubitemid 26149229)
21. Kirby KC, Marlowe DB, Festinger DS, Lamb RJ, Platt JJ. Schedule of voucher delivery influences initiation of cocaine abstinence. J Consult Clin Psychol 1998; 66(5):761-767. (Pubitemid 28478343)
22. Petry NM, Martin B, Simcic F, Jr. Prize reinforcement contingency management for cocaine dependence: Integration with group therapy in a methadone clinic. J Consult Clin Psychol 2005; 73(2):354-359. (Pubitemid 40446393)
23. McKee SA, Carroll KM, Sinha R, Robinson JE, Nich C, Cavallo D, OMalley S. Enhancing brief cognitive-behavioral therapy with motivational enhancement techniques in cocaine users. Drug Alcohol Depend 2007; 91(1):97-101. (Pubitemid 47385030)
24. Carroll KM, Rounsaville BJ, Gordon LT, Nich C, Jatlow P, Bisighini RM, Gawin FH. Psychotherapy and pharmacotherapy for ambulatory cocaine abusers. Arch Gen Psychiatry 1994; 51(3):177-187. (Pubitemid 24081507)
25. Baker A, Lee NK, Claire M, Lewin TJ, Grant T, Pohlman S, Saunders JB, Kay-Lambkin F, Constable P, Jenner L, Carr VJ. Brief cognitive behavioural interventions for regular amphetamine users: A step in the right direction. Addiction 2005; 100(3):367-378. (Pubitemid 40363443)
26. Somoza E, Somoza P, Lewis D, Li SH, Winhusen T, Chiang N, Vocci F, Horn P, Elkashef A. The SRPHK1 outcome measure for cocaine-dependence trials combines self-report, urine benzoylecgonine levels, and the concordance between the two to determine a cocaine-use status for each study day. Drug Alcohol Depend 2008; 93(1-2):132-140. (Pubitemid 350236600)
27. Carroll KM, Fenton LR, Ball SA, Nich C, Frankforter TL, Shi J, Rounsaville BJ. Efficacy of disulfiram and cognitive behavior therapy in cocaine-dependent outpatients: A randomized placebo-controlled trial. Arch Gen Psychiatry 2004; 61(3):264-272. (Pubitemid 38295828)
28. Marcus BH, Albrecht AE, King TK, Parisi AF, Pinto BM, Roberts M, Niaura RS, Abrams DB. The efficacy of exercise as an aid for smoking cessation in women: A randomized controlled trial. Arch Intern Med 1999; 159(11):1229-1234. (Pubitemid 29269863)
29. Martin JE, Calfas KJ, Patten CA, Polarek M, Hofstetter CR, Noto J, Beach D. Prospective evaluation of three smoking interventions in 205 recovering alcoholics: One-year results of Project SCRAP-Tobacco. J Consult Clin Psychol 1997; 65(1):190-194. (Pubitemid 27086150)
30. Marcus BH, Lewis BA, Hogan J, King TK, Albrecht AE, Bock B, Parisi AF, Niaura R, Abrams DB. The efficacy of moderateintensity exercise as an aid for smoking cessation in women: A randomized controlled trial. Nicotine Tob Res 2005; 7(6):871-880. (Pubitemid 43101705)
31. Carroll KM, Nich C, Ball SA, McCance E, Rounsavile BJ. Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram. Addiction 1998; 93(5): 713-727. (Pubitemid 28230603)
32. Sobell LC, Sobell MB. Timeline follow-back: A technique for assessing self-reported alcohol consumption. In Measuring Alcohol Consumption: Psychosocial and Biological Methods. Litten RZ, Allen JP, eds. Totowa, NJ: Humana Press, 1992; 41-72.
33. Nunes EV, McGrath PJ, Quitkin FM, Ocepek-Welikson K, Stewart JW, Koenig T, Wager S, Klein DF. Imipramine treatment of cocaine abuse: Possible boundaries of efficacy. Drug Alcohol Depend 1995; 39(3):185-195.
34. Nunes EV, Quitkin FM, Donovan SJ, Deliyannides D, Ocepek-Welikson K, Koenig T, Brady R, McGrath PJ,Woody G. Imipramine treatment of opiate-dependent patients with depressive disorders. A placebo-controlled trial. Arch Gen Psychiatry 1998; 55(2):153-160. (Pubitemid 28087601)
35. Magura S, Kang SY. Validity of self-reported drug use in high risk populations: A meta-analytical review. Subst Use Misuse 1996; 31(9):1131-1153. (Pubitemid 26260006)
36. Hersh D, Mulgrew CL, Van Kirk J, Kranzler HR. The validity of self-reported cocaine use in two groups of cocaine abusers. J Consult Clin Psychol 1999; 67(1):37-42. (Pubitemid 29077507)
37. Shiffman S. How many cigarettes did you smoke? Assessing cigarette consumption by global report, time-line follow-back, and ecological momentary assessment. Health Psychol 2009; 28(5):519-526.
38. McLellan AT, Luborsky L, Woody GE, OBrien CP. An improved diagnostic evaluation instrument for substance abuse patients. The addiction severity index. J Nerv Ment Dis 1980; 168(1):26-33. (Pubitemid 10187569)
39. Cacciola JS, Alterman AI, McLellan AT, Lin YT, Lynch KG. Initial evidence for the reliability and validity of a "Lite" version of the addiction severity index. Drug Alcohol Depend 2007; 87(2-3):297-302. (Pubitemid 46217911)
40. Winhusen TM, Somoza EC, Singal B, Kim S, Horn PS, Rotrosen J. Measuring outcome in cocaine clinical trials: A comparison of sweat patches with urine toxicology and participant self-report. Addiction 2003; 98(3):317-324. (Pubitemid 36269570)
41. Hawks RL, Chiang CN. Examples of specific drug assays. NIDA Res Monogr 1986; 73:84-112. (Pubitemid 17167599)
42. Daniel CR, III, Piraccini BM, Tosti A. The nail and hair in forensic science. J Am Acad Dermatol 2004; 50(2):258-261. (Pubitemid 38174285)
43. Rollins DE, Wilkins DG, Krueger GG, Augsburger MP, Mizuno A, ONeal C, Borges CR, Slawson MH. The effect of hair color on the incorporation of codeine into human hair. J Anal Toxicol 2003; 27:545-551. (Pubitemid 37500375)
44. Blank DL, Kidwell DA. External contamination of hair by cocaine: An issue in forensic interpretation. Forensic Sci Int 1993; 63:145-156. (Pubitemid 24045449)
45. Wang WL, Cone EJ. Testing human hair for drugs of abuse. IV. Environmental cocaine contamination and washing effects. Forensic Sci Int 1995; 70:39-51.
46. Miller WR, Manuel JK. How large must a treatment effect be before it matters to practitioners? An estimation method and demonstration. Drug Alcohol Rev 2008; 27(5):524-528.