Evaluation of buspirone for relapse-prevention in adults with cocaine dependence: An efficacy trial conducted in the real world

Contemporary Clinical Trials

Volumn 33, Issue 5, 2012, Pages 993-1002

  Winhusen, Theresa ^a   Brady, Kathleen T ^b   Stitzer, Maxine ^c   Woody, George ^d   Lindblad, Robert ^e   Kropp, Frankie ^a   Brigham, Gregory ^a,f   Liu, David ^g   Sparenborg, Steven ^g   Sharma, Gaurav ^e   VanVeldhuisen, Paul ^e   Adinoff, Bryon ^h,i   Somoza, Eugene ^a,j  

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

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

^e EMMES CORPORATION   (United States)

^f Maryhaven   (United States)

^g NATIONAL INSTITUTE ON DRUG ABUSE   (United States)

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

ⁱ VA NORTH TEXAS HEALTH CARE SYSTEM   (United States)

^j VETERANS AFFAIRS MEDICAL CENTER   (United States)

more..

Author keywords

Buspirone; Cocaine; Contingency management; Relapse prevention

Indexed keywords

BUSPIRONE; ILLICIT DRUG; PLACEBO;

ADULT; ARTICLE; COCAINE DEPENDENCE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; FEMALE; FUNCTIONAL STATUS; HELP SEEKING BEHAVIOR; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MEASUREMENT ERROR; MORNING DOSAGE; OUTCOME ASSESSMENT; PATIENT MONITORING; PREVENTION STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RELAPSE; SELF REPORT; TREATMENT DURATION; TREATMENT RESPONSE; URINALYSIS; URINE DRUG SCREEN; WITHDRAWAL SYNDROME;

AFTERCARE; BUSPIRONE; COCAINE-RELATED DISORDERS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MEDICATION ADHERENCE; MULTICENTER STUDIES AS TOPIC; OUTPATIENTS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECURRENCE; RISK-TAKING; SECONDARY PREVENTION; SEROTONIN RECEPTOR AGONISTS; TREATMENT OUTCOME;

EID: 84864294070     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.05.003     Document Type: Article

References (69)

1. Winhusen T., Somoza E., Ciraulo D., Harrer J.M., Goldsmith R.J., Grabowski J., et al. A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence. Drug Alcohol Depend 2007, 91:141-148.
2. Substance Abuse and Mental Health Services Administration Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings. Office of Applied Studies, NSDUH Series H-38A, HHS Publication No. SMA 10-4856 Findings 2010, Rockville, MD.
3. UNODC World Drug Report 2010. United Nations Publication, Sales No. E.10.XI.13 2010.
4. Kuehn B.M. Scientists target cocaine addiction. JAMA 2009, 302(24):2641-2642.
5. Vorel S.R., Ashby C.R., Paul M., Liu X., Hayes R., Hagan J.J. Dopamine d3 receptor antagonism inhibits cocaine-seeking and cocaine-enhanced brain reward in rats. J Neurosci 2002, 22(21):9595-9603.
6. Xi Z., Newman A.H., Gilbert J.G., Pak A.C., Peng X., Ashby C.R., et al. The novel dopamine d3 receptor antagonist NGB 2904 inhibits cocaine's rewarding effects and cocaine-induced reinstatement of drug-seeking behavior in rats. Neuropsychopharmacology 2006, 31:1393-1405.
7. Heidbreder C.A., Newman A.H. Current perspectives on selective dopamine d3 receptor antagonists as pharmacotherapeutics for addictions and related disorders. Ann N Y Acad Sci 2010, 1187:4-34.
8. Boileau I., Payer D., Houle S., Behzadi A., Rusjan P.M., Tong J., et al. Higher binding of the dopamine d3 receptor-preferring ligand [11C]-(+)-propyl-hexahydro-naphtho-oxazin in methamphetamine polydrug users: a positron emission tomography study. J Neurosci 2012, 32(4):1353-1359.
9. Back S.E., Hartwell K., DeSantis S.M., Saladin M., McRae-Clark A.L., Price K.L., et al. Reactivity to laboratory stress provocation predicts relapse to cocaine. Drug Alcohol Depend 2010, 106(1):21-27.
10. Schmitz J.M., Stotts A.L., Rhoades H.M., Grabowski J. Naltrexone and relapse prevention treatment for cocaine-dependent patients. Addict Behav 2001, 26:167-180.
11. Sinha R., Garcia M., Paliwal P., Kreek M.J., Rounsaville B.J. Stress-induced cocaine craving and hypothalamic-pituitary-adrenal responses are predictive of cocaine relapse outcomes. Arch Gen Psychiatry 2006, 63:324-331.
12. Paliwal P., Hyman S., Sinha R. Craving predicts time to cocaine relapse: further validation of the now and brief versions of the cocaine craving questionnaire. Drug Alcohol Depend 2008, 93:252-259.
13. Hyman S.M., Paliwal P., Chaplin T.M., Mazure C.M., Rounsaville B.J., Sinha R. Severity of childhood trauma is predictive of cocaine relapse outcomes in women but not men. Drug Alcohol Depend 2008, 92(1-3):208-216.
14. Lader M. Can buspirone induce rebound, dependence, or abuse?. Br J Psychiatry 1991, 159:45-51. [Suppl.].
15. Julien R.M. A primer of drug action: a concise, nontechnical guide to the actions, uses, and side effects of psychoactive drugs 2005, WH Freeman, New York. 10th ed.
16. Kula N.S., Baldessarini R.J., Kebabian J.W., Neumeyer J.L. S(+)-Aporphines are not selective for human D3 dopamine receptors. Cell Mol Neurobiol 1994, 14:185-191.
17. Bruno F. Buspirone in the treatment of alcoholic patients. Psychopathology 1989, 22(Suppl. 1):49-59.
18. Malcolm R., Anton R.F., Randall C.L., Johnston A., Brady K., Thevos A. A placebo-controlled trial of buspirone in anxious inpatient alcoholics. Alcohol Clin Exp Res 1992, 16:1007-1013.
19. Tollefson G.D., Montague-Clouse J., Tollefson S.L. Treatment of comorbid generalized anxiety in a recently detoxified alcoholic population with a selective serotonergic drug (buspirone). J Clin Psychopharmacol 1992, 12(1):19-26.
20. Kranzler H.R., Burleson J.A., Del Boca F.K., Babor T.F., Korner P., Brown J., et al. Buspirone treatment of anxious alcoholics. A placebo-controlled trial. Arch Gen Psychiatry 1994, 51(9):720-731.
21. Malec E., Malec T., Gagné M.A., Dongier M. Buspirone in the treatment of alcohol dependence: a placebo-controlled trial. Alcohol Clin Exp Res 1996, 20:307-312.
22. McRae A.L., Sonne S.C., Brady K.T., Durkalski V., Palesch Y. A randomized, placebo-controlled trial of buspirone for the treatment of anxiety in opioid-dependent individuals. Am J Addict 2004, 13(1):53-63.
23. McRae A.L., Brady K.T., Carter R.E. Buspirone for treatment of marijuana dependence: a pilot study. Am J Addict 2006, 15(5):404.
24. McRae-Clark A.L., Carter R.E., Killeen T.K., Carpenter M.J., Wahlquist A.E., Simpson S.A., et al. A placebo-controlled trial of buspirone for the treatment of marijuana dependence. Drug Alcohol Depend 2009, 105(1-2):132-138.
25. Giannini A.J., Loiselle R.H., Graham B.H., Folts D.J. Behavioral response to buspirone in cocaine and phencyclidine withdrawal. J Subst Abuse Treat 1993, 10(6):523-527.
26. Moeller F.G., Dougherty D.M., Barratt E.S., Schmitz J.M., Swann A.C., Grabowski J. The impact of impulsivity on cocaine use and retention in treatment. J Subst Abuse Treat 2001, 21(4):193-198.
27. Brady K.T., Gray K.M., Tolliver B.K. Cognitive enhancers in the treatment of substance use disorders: clinical evidence. Pharmacol Biochem Behav 2011, 99(2):285-294.
28. Winhusen T., Winstanley E., Somoza E., Brigham G. The impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD. Drug Alcohol Depend 2012, 120:225-228.
29. Berger S.P., Winhusen T.M., Somoza E.C., Harrer J.M., Mezinskis J.P., Leiderman D.B., et al. A medication screening trial evaluation of reserpine, gabapentin, and lamotrigine pharmacotherapy of cocaine dependence. Addiction 2005, 100(Suppl. 1):58-67.
30. Winhusen T., Somoza E., Sarid-Segal O., Goldsmith R.J., Harrer J.M., Coleman F.S., et al. A double-blind, placebo-controlled trial of reserpine for the treatment of cocaine dependence. Drug Alcohol Depend 2007, 91(2-3):205-212.
31. Winhusen T.M., Somoza E.C., Harrer J.M., Mezinskis J.P., Montgomery M.A., Goldsmith R.J., et al. A placebo-controlled screening trial of tiagabine, sertraline, and donepezil as cocaine dependence treatments. Addiction 2005, 100(Suppl. 1):68-77.
32. Kraemer H.C., Mintz J., Noda A., Tinklenberg J., Yesavage J.A. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry 2006, 63(5):484-489.
33. Bridging the gap between practice and research, forging partnerships with community-based drug and alcohol treatment 1998, National Academy Press, Washington, DC. S. Lamb, M.R. Greenlick, D. McCarty (Eds.).
34. Mooney M., Sayre S., Green C., Rhoades H., Schmitz J. Comparing measures of medication taking in a pharmacotherapy trial for cocaine dependence. Addict Disord Treat 2004, 3:165-173.
35. Sorensen J.L., Haug N.A., Delucchi K.L., Gruber V., Kletter E., Batki S.L., et al. Voucher reinforcement improves medication adherence in HIV-positive methadone patients: a randomized trial. Drug Alcohol Depend 2007, 88(1):54-63.
36. Stone V.E. Strategies for optimizing adherence to highly active antiretroviral therapy: lessons from research and clinical practice. Clin Infect Dis 2001, 33(6):865-872.
37. Osterberg L., Blaschke T. Drug therapy adherence to medication. N Engl J Med 2005, 353:487-497.
38. Schmitz J.M., Lindsay J.A., Stotts A.L., Green C.E., Moeller F.G. Contingency management and levodopa-carbidopa for cocaine treatment: a comparison of three behavioral targets. Exp Clin Psychopharmacol 2010, 18(3):238-244.
39. Carroll K.M., Sinha R., Nich C., Babuscio T., Rounsaville B.J. Contingency management to enhance naltrexone treatment of opioid dependence: a randomized clinical trial of reinforcement magnitude. Exp Clin Psychopharmacol 2002, 10:54-63.
40. Carroll K.M., Ball S.A., Nich C., O'Connor P.G., Eagan D.A., Frankforter T.L., et al. Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence. Arch Gen Psychiatry 2001, 58:755-761.
41. Preston K.L., Silverman K., Umbricht A., DeJusus A., Montoya I.D., Schuster C.R. Improvement in naltrexone treatment compliance with contingency management. Drug Alcohol Depend 1999, 54:127-135.
42. Seal K.H., Kral A.H., Lorvick J. A randomized controlled trial of monetary incentives vs. outreach to enhance adherence to the hepatitis B vaccine series among injection drug users. Drug Alcohol Depend 2003, 71:127-131.
43. Rigsby M.O., Rosen M.I., Beauvais J.E., Cramer J.A., Rainey P.M., O'Malley S.S., et al. Cue-dose training with monetary reinforcement: pilot study of an antiretroviral adherence intervention. J Gen Intern Med 2000, 15(12):841-847.
44. Havassy B., Wasserman D., Hall S. Relapse to cocaine use: conceptual issues. NIDA Research Monograph 1993, 135:203-217. National Institute on Drug Abuse, Rockville, MD. F.M. Tims, C.G. Leukefeld (Eds.).
45. Jones H.E., Johnson R.E., Bigelow G.E., Silverman K., Mudric T., Strain E.C. Safety and efficacy of l-tryptophan and behavioral incentives for treatment of cocaine dependence: a randomized clinical trial. Am J Addict 2004, 13:421-437.
46. Sobell L.C., Sobell M.B. Timeline follow back: a technique for assessing self-reported ethanol consumption. Techniques to Assess Alcohol Consumption 1992, 19-28. Humana Press, Inc., New Jersey. J. Allen, R. Litten (Eds.).
47. Fals-Stewart W., O'Farrell T.J., Freitas T.T., McFarlin S.K., Rutigliano P. The timeline followback reports of psychoactive substance use by drug-abusing patients: psychometric properties. J Consult Clin Psychol 2000, 68:134-144.
48. McLellan A.T., Kushner H., Metzger D., Peters R., Smith I., Grissom G., et al. The fifth edition of the Addiction Severity Index. J Subst Abuse Treat 1992, 9:199-213.
49. Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med 1998, 28:551-558. WHOQOL Group.
50. Robinson T.E., Berridge K.C. The neural basis of drug craving: an incentive-sensitization theory of addiction. Brain Res Brain Res Rev 1993, 18(3):247-291.
51. Robinson T.E., Berridge K.C. The incentive sensitization theory of addiction: some current issues. Philos Trans R Soc Lond B Biol Sci 2008, 363(1507):3137-3146.
52. Berridge K.C., Robinson T.E., Aldridge J.W. Dissecting components of reward: 'liking', 'wanting', and learning. Curr Opin Pharmacol 2009, 9(1):65-73.
53. American Psychiatric Association Diagnostic and statistical manual of mental disorders, fourth edition, text revision 2000, American Psychiatric Association, Washington, DC.
54. Everitt B.J., Belin D., Economidou D., Pelloux Y., Dalley J.W., Robbins T.W. Neural mechanisms underlying the vulnerability to develop compulsive drug-seeking habits and addiction. Philos Trans R Soc Lond B Biol Sci 2008, 363(1507):3125-3135.
55. Carpenter K.M., Schreiber E., Church S., McDowell D. Drug Stroop performance: relationships with primary substance of use and treatment outcome in a drug-dependent outpatient sample. Addict Behav 2006, 31(1):174-181.
56. Vadhan N.P., Carpenter K.M., Copersino M.L., Hart C.L., Foltin R.W., Nunes E.V. Attentional bias towards cocaine-related stimuli: relationship to treatment-seeking for cocaine dependence. Am J Drug Alcohol Abuse 2007, 33(5):727-736.
57. Ersche K.D., Bullmore E.T., Craig K.J., Shabbir S.S., Abbott S., Müller U., et al. Influence of compulsivity of drug abuse on dopaminergic modulation of attentional bias in stimulant dependence. Arch Gen Psychiatry 2010, 67(6):632-644.
58. Franken I.H., Hendriks V.M., Stam C.J., Van den Brink W. A role for dopamine in the processing of drug cues in heroin dependent patients. Eur Neuropsychopharmacol 2004, 14(6):503-508.
59. Baler R.D., Volkow N.D. Drug Addiction: the neurobiology of disrupted self-control. Trends Mol Med 2006, 12(12):559-566.
60. Franken I.H., Kroon L.Y., Hendriks V.M. Influence of individual differences in craving and obsessive cocaine thoughts on attentional processes in cocaine abuse patients. Addict Behav 2000, 25(1):99-102.
61. Franken I.H., Hendriksa V.M., van den Brink W. Initial validation of two opiate craving questionnaires: The Obsessive Compulsive Drug Use Scale and the Desires for Drug Questionnaire. Addict Behav 2002, 27(5):675-685.
62. Sussner B.D., Smelson D.A., Rodrigues S., Kline A., Losonczy M., Ziedonis D. The validity and reliability of a brief measure of cocaine craving. Drug Alcohol Depend 2006, 83(3):233-237.
63. Cohen J. Statistical power analysis of the behavioral sciences 1988, Lawrence Erlbaum Associates, Hillsdale, NJ.
64. Zigmond A.S., Snaith R.P. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983, 67:361-370.
65. Bjelland I., Dahl A.A., Haug T.T., Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: an updated literature review. J Psychosom Res 2002, 52:69-77.
66. Winhusen T., Stitzer M., Woody G., Brigham G., Kropp F., Ghitza U., et al. Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals. Contemp Clin Trials 2012, 33(1):197-205.
67. Baron R.M., Kenny D.A. The moderator-mediator variable distinction in social psychological research: conceptual, strategic and statistical considerations. J Pers Soc Psychol 1986, 51:1173-1182.
68. Judd C.M., Kenny D.A. Process analysis: estimating mediation in treatment evaluations. Eval Rev 1981, 5:602-619.
69. Sobel M.E. Asymptotic confidence intervals for indirect effects in structural equation models. Sociol Methodol 1982, 13:290-312.