Opioid substitution and antagonist therapy trials exclude the common addiction patient: A systematic review and analysis of eligibility criteria

Trials

Volumn 16, Issue 1, 2015, Pages 1-

  Dennis, Brittany B ^a   Roshanov, Pavel S ^b   Naji, Leen ^c   Bawor, Monica ^a   Paul, James ^a   Plater, Carolyn ^d   Pare, Guillaume ^a   Worster, Andrew ^d,e   Varenbut, Michael ^d   Daiter, Jeff ^d   Marsh, David C ^d,f   Desai, Dipika ^g   Samaan, Zainab ^a,g,h   Thabane, Lehana ^a,i,j  

^a MCMASTER UNIVERSITY   (Canada)

^b WESTERN UNIVERSITY   (Canada)

^c MCMASTER UNIVERSITY   (Canada)

^d Canadian Addiction Treatment Centres   (Canada)

^e HAMILTON GENERAL HOSPITAL   (Canada)

^f NORTHERN ONTARIO SCHOOL OF MEDICINE   (Canada)

^g MCMASTER UNIVERSITY   (Canada)

^h MCMASTER UNIVERSITY   (Canada)

ⁱ CENTRE FOR EVALUATION OF MEDICINES   (Canada)

^j MCMASTER UNIVERSITY   (Canada)

more..

Author keywords

Comorbidity; Generalizability; Methadone maintenance treatment; Methodology; Opioid addiction; Opioid dependence; Opioid use disorder; Psychiatric comorbidity

Indexed keywords

BUPRENORPHINE; METHADONE; NALOXONE; NALTREXONE; OPIATE; PSYCHOTROPIC AGENT; NARCOTIC ANTAGONIST;

ALCOHOL ABUSE; ARTICLE; CLINICAL ASSESSMENT; COHORT ANALYSIS; COMORBIDITY; HUMAN; MAINTENANCE THERAPY; META ANALYSIS; OBSERVATIONAL STUDY; OPIATE ADDICTION; PREVALENCE; PROSPECTIVE STUDY; PSYCHOLOGICAL WELL BEING; SUBSTANCE ABUSE; SYSTEMATIC REVIEW; WORLD HEALTH ORGANIZATION; ADVERSE EFFECTS; DRUG USE; EVIDENCE BASED MEDICINE; OPIATE SUBSTITUTION TREATMENT; OPIOID-RELATED DISORDERS; ORGANIZATION AND MANAGEMENT; PATIENT SELECTION; PRACTICE GUIDELINE; PROCEDURES; PSYCHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); STANDARDS; TREATMENT OUTCOME;

COMORBIDITY; DRUG USERS; ELIGIBILITY DETERMINATION; EVIDENCE-BASED MEDICINE; HUMANS; NARCOTIC ANTAGONISTS; OPIATE SUBSTITUTION TREATMENT; OPIOID-RELATED DISORDERS; PATIENT SELECTION; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84945178104     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0942-4     Document Type: Article

References (91)

1. Zapata JT, Katims DS, Yin Z. A two-year study of patterns and predictors of substance use among Mexican American youth. Adolescence. 1998;33:391-403.
2. Kilpatrick DG, Acierno R, Saunders B, Resnick HS, Best CL, Schnurr PP. Risk factors for adolescent substance abuse and dependence: data from a national sample. J Consult Clin Psychol. 2000;68:19-30.
3. Grant BF, Goldstein RB, Chou SP, Huang B, Stinson FS, Dawson DA, et al. Sociodemographic and psychopathologic predictors of first incidence of DSM-IV substance use, mood and anxiety disorders: results from the Wave 2 National Epidemiologic Survey on Alcohol and Related Conditions. Mol Psychiatry. 2009;14:1051-66.
4. United Nations Office on Drugs and Crime. World Drug Report. Vienna, Austria: United Nations; 2015. (United Nations publication, Sales No. E.15.XI.6).
5. Substance Abuse and Mental Health Services Administration OAS. Results from the 2012 National Survey on Drug Use and Health: summary of national findings. In: NSDUH Series H-46. Rockville: Substance Abuse and Mental Health Services Administration; 2013.
6. Birnbaum HG, White AG, Schiller M, Waldman T, Cleveland JM, Roland CL. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12:657-67.
7. Disley E, Mulcahy A, Pardal M, Rubin J, Ruggeri K. Development of a framework to estimate the cost of opioid dependence. Cambridge, UK: RAND Europe; 2013.
8. World Health Organization. World Drug Report. New York: United Nations Offices on Drugs and Crime (UNODC); 2012.
9. Center for Substance Abuse Treatment. Medication-assisted treatment for opioid addiction in opioid treatment programs, Treatment improvement protocol (TIP) Series 43: DHHS Publication No. (SMA) 05-4048. Rockville: Substance Abuse and Mental Health Services Administration; 2005.
10. Substance Abuse and Mental Health Services Administration OAS. Treatment episode data set (TEDS): 2005 discharges from substance abuse treatment services, DASIS Series S-41, DHHS Publication No. (SMA) 08-4314. Rockville: Substance Abuse and Mental Health Services Administration; 2008.
11. Clausen T, Anchersen K, Waal H. Mortality prior to, during and after opioid maintenance treatment (OMT): a national prospective cross-registry study. Drug Alcohol Depend. 2008;94:151-7.
12. The College of Physicians and Surgeons of Ontario. Methadone maintenance treatment program standards and clinical guidelines. 4th ed. Toronto: The College of Physicians and Surgeons of Ontario; 2011.
13. Veterans Affairs/Department of Defense clinical practice guideline for management of substance use disorders (SUD). Washington (DC): Veterans Health Association, Department of Defense; 2009.
14. Handford C, Kahan M, Srivastava A, Cirone S, Sanghera S, Palda V, et al. Buprenorphine/naloxone for opioid dependence: clinical practice guideline. Toronto: Centre for Addiction and Mental Health; 2011. Available at http://www.guideline.gov/content.aspx?id=39351&search=methadone.
15. National Collaborating Centre for Mental Health. Drug misuse: opioid detoxification. Leicester and London: The British Psychological Society and the Royal College of Psychiatrists; 2008.
16. Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297:1233-40.
17. Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003;349:949-58.
18. Johnson RE, Jaffe JH, Fudala PJ. A controlled trial of buprenorphine treatment for opioid dependence. JAMA. 1992;267:2750-5.
19. Schottenfeld RS, Chawarski MC, Mazlan M. Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;371:2192-200.
20. Sees KL, Delucchi KL, Masson C, Rosen A, Clark HW, Robillard H, et al. Methadone maintenance vs 180-day psychosocially enriched detoxification for treatment of opioid dependence: a randomized controlled trial. JAMA. 2000;283:1303-10.
21. Eissenberg T, Bigelow GE, Strain EC, Walsh SL, Brooner RK, Stitzer ML, et al. Dose-related efficacy of levomethadyl acetate for treatment of opioid dependence. A randomized clinical trial. JAMA. 1997;277:1945-51.
22. Oviedo-Joekes E, Brissette S, Marsh DC, Lauzon P, Guh D, Anis A, et al. Diacetylmorphine versus methadone for the treatment of opioid addiction. N Engl J Med. 2009;361:777-86.
23. Woody GE, Poole SA, Subramaniam G, Dugosh K, Bogenschutz M, Abbott P, et al. Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial. JAMA. 2008;300:2003-11.
24. Kakko J, Svanborg KD, Kreek MJ, Heilig M. 1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trial. Lancet. 2003;361:662-8.
25. Strain EC, Bigelow GE, Liebson IA, Stitzer ML. Moderate- vs high-dose methadone in the treatment of opioid dependence: a randomized trial. JAMA. 1999;281:1000-5.
26. Rondinelli AJ, Ouellet LJ, Strathdee SA, Latka MH, Hudson SM, Hagan H, et al. Young adult injection drug users in the United States continue to practice HIV risk behaviors. Drug Alcohol Depend. 2009;104:167-74.
27. Darke S, Kaye S, McKetin R, Duflou J. Major physical and psychological harms of methamphetamine use. Drug Alcohol Rev. 2008;27:253-62.
28. Darke S, Hall W. Levels and correlates of polydrug use among heroin users and regular amphetamine users. Drug Alcohol Depend. 1995;39:231-5.
29. Wu LT, Woody GE, Yang C, Blazer DG. How do prescription opioid users differ from users of heroin or other drugs in psychopathology: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Addict Med. 2011;5:28-35.
30. Pilowsky DJ, Wu LT, Burchett B, Blazer DG, Woody GE, Ling W. Co-occurring amphetamine use and associated medical and psychiatric comorbidity among opioid-dependent adults: results from the Clinical Trials Network. Subst Abuse Rehabil. 2011;2:133-44.
31. Kosten TR, Rounsaville BJ, Kleber HD. A 2.5-year follow-up of depression, life crises, and treatment effects on abstinence among opioid addicts. Arch Gen Psychiatry. 1986;43:733-8.
32. Compton 3rd WM, Cottler LB, Jacobs JL, Ben-Abdallah A, Spitznagel EL. The role of psychiatric disorders in predicting drug dependence treatment outcomes. Am J Psychiatry. 2003;160:890-5.
33. Rounsaville BJ, Weissman MM, Crits-Christoph K, Wilber C, Kleber H. Diagnosis and symptoms of depression in opiate addicts. Course and relationship to treatment outcome. Arch Gen Psychiatry. 1982;39:151-6.
34. Rounsaville BJ, Kosten TR, Weissman MM, Kleber HD. Prognostic significance of psychopathology in treated opiate addicts. A 2.5-year follow-up study. Arch Gen Psychiatry. 1986;43:739-45.
35. Storbjork J. Implications of enrolment eligibility criteria in alcohol treatment outcome research: generalisability and potential bias in 1- and 6-year outcomes. Drug Alcohol Rev. 2014;33:604-11.
36. Finney JW. Limitations in using existing alcohol treatment trials to develop practice guidelines. Addiction. 2000;95:1491-500.
37. Blanco C, Olfson M, Okuda M, Nunes EV, Liu SM, Hasin DS. Generalizability of clinical trials for alcohol dependence to community samples. Drug Alcohol Depend. 2008;98:123-8.
38. Humphreys K, Weisner C. Use of exclusion criteria in selecting research subjects and its effect on the generalizability of alcohol treatment outcome studies. Am J Psychiatry. 2000;157:588-94.
39. Okuda M, Hasin DS, Olfson M, Khan SS, Nunes EV, Montoya I, et al. Generalizability of clinical trials for cannabis dependence to community samples. Drug Alcohol Depend. 2010;111:177-81.
40. Humphreys K, Harris AH, Weingardt KR. Subject eligibility criteria can substantially influence the results of alcohol-treatment outcome research. J Stud Alcohol Drugs. 2008;69:757-64.
41. Dennis BB, Naji L, Bawor M, Bonner A, Varenbut M, Daiter J, et al. The effectiveness of opioid substitution treatments for patients with opioid dependence: a systematic review and multiple treatment comparison protocol. Syst Rev. 2014;3:105.
42. Higgins JPT, Green S, editors. The Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0: The Cochrane Collaboration. 2011.
43. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37-46.
44. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700.
45. Samaan Z, Bawor M, Dennis B, Plater C, Worster A, Varenbut M, et al. Genetic influence in methadone dose and response to treatment in patients undergoing methadone maintenance treatment (MMT) for opioid addiction: a pilot study. Neuropsychiatr Dis Treat. 2014;10:1503-8.
46. Cleeland C. The brief pain inventory: user guide. Houston: Pain Research Group; 1991.
47. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33. quiz 34-57.
48. Marsden J, Gossop M, Stewart D, Best D, Farrell M, Lehmann P, et al. The Maudsley Addiction Profile (MAP): a brief instrument for assessing treatment outcome. Addiction. 1998;93:1857-67.
49. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol. 2010;63:1308-11.
50. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. Development of the AGREE II, part 2: assessment of validity of items and tools to support application. CMAJ. 2010;182:E472-8.
51. StataCorp. Stata Statistical Software: Release 12. College Station, TX: StataCorp LP; 2009.
52. National Treatment Association Guidance. Methadone and buprenorphine for the management of opioid dependence. London, UK: National Institute for Health and Care Excellence; 2007.
53. World Health Organization. Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence. Geneva: World Health Organization; 2009.
54. Schottenfeld RS, Chawarski MC, Pakes JR, Pantalon MV, Carroll KM, Kosten TR. Methadone versus buprenorphine with contingency management or performance feedback for cocaine and opioid dependence. Am J Psychiatry. 2005;162:340-9.
55. Neri S, Bruno CM, Pulvirenti D, Malaguarnera M, Italiano C, Mauceri B, et al. Randomized clinical trial to compare the effects of methadone and buprenorphine on the immune system in drug abusers. Psychopharmacology (Berl). 2005;179:700-4.
56. Mattick Richard P, Kimber J, Breen C, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014;2:CD002207.
57. Banta-Green CJ, Maynard C, Koepsell TD, Wells EA, Donovan DM. Retention in methadone maintenance drug treatment for prescription-type opioid primary users compared to heroin users. Addiction. 2009;104:775-83.
58. Johansson BA, Berglund M, Lindgren A. Efficacy of maintenance treatment with methadone for opioid dependence: a meta-analytical study. Nord J Psychiatry. 2007;61:288-95.
59. Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64:383-94.
60. Nides M, Oncken C, Gonzales D, Rennard S, Watsky EJ, Anziano R, et al. Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med. 2006;166:1561-8.
61. Westly E: Why do clinical trials exclude depressed people? In: Reuters. New York, NY. 2011-03-18.
62. Glyngdal P, Sorensen P, Kistrup K. Non-compliance in community psychiatry: failed appointments in the referral system to psychiatric outpatient treatment. Nord J Psychiatry. 2002;56:151-6.
63. Mbuagbaw L, van der Kop ML, Lester RT, Thirumurthy H, Pop-Eleches C, Ye C, et al. Mobile phone text messages for improving adherence to antiretroviral therapy (ART): an individual patient data meta-analysis of randomised trials. BMJ Open. 2013;3:e003950.
64. Mbuagbaw L, Thabane L, Ongolo-Zogo P. Opening communication channels with people living with HIV using mobile phone text messaging: insights from the CAMPS trial. BMC Res Notes. 2013;6:131.
65. Kane JM. Improving patient outcomes in schizophrenia: achieving remission, preventing relapse, and measuring success. J Clin Psychiatry. 2013;74:e18.
66. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis. 1967;20:637-48.
67. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015;156:569-76.
68. Kessler RC. The epidemiology of dual diagnosis. Biol Psychiatry. 2004;56:730-7.
69. Marrie RA, Fisk JD, Yu BN, Leung S, Elliott L, Caetano P, et al. Mental comorbidity and multiple sclerosis: validating administrative data to support population-based surveillance. BMC Neurol. 2013;13:16.
70. Farre M, Mas A, Torrens M, Moreno V, Cami J. Retention rate and illicit opioid use during methadone maintenance interventions: a meta-analysis. Drug Alcohol Depend. 2002;65:283-90.
71. Fischer B, Cruz MF, Rehm J. Illicit opioid use and its key characteristics: a select overview and evidence from a Canadian multisite cohort of illicit opioid users (OPICAN). Can J Psychiatry. 2006;51:624-34.
72. Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000;343:1290-7.
73. Lintzeris N, Ritter A, Panjari M, Clark N, Kutin J, Bammer G. Implementing buprenorphine treatment in community settings in Australia: experiences from the Buprenorphine Implementation Trial. Am J Addict. 2004;13 Suppl 1:S29-41.
74. Marsch LA. The efficacy of methadone maintenance interventions in reducing illicit opiate use, HIV risk behavior and criminality: a meta-analysis. Addiction. 1998;93:515-32.
75. Mattick RP, Ali R, White JM, O'Brien S, Wolk S, Danz C. Buprenorphine versus methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent patients. Addiction. 2003;98:441-52.
76. Strain EC, Stitzer ML, Liebson IA, Bigelow GE. Dose-response effects of methadone in the treatment of opioid dependence. Ann Intern Med. 1993;119:23-7.
77. Strain EC, Stitzer ML, Liebson IA, Bigelow GE. Methadone dose and treatment outcome. Drug Alcohol Depend. 1993;33:105-17.
78. Adi Y, Juarez-Garcia A, Wang D, Jowett S, Frew E, Day E, et al. Oral naltrexone as a treatment for relapse prevention in formerly opioid-dependent drug users: a systematic review and economic evaluation. Health Technol Assess. 2007;11:iii-iv. 1-85.
79. Minozzi S, Amato L, Vecchi S, Davoli M, Kirchmayer U, Verster A. Oral naltrexone maintenance treatment for opioid dependence. Cochrane Database Syst Rev 2006:CD001333. doi: 10.1002/14651858.CD001333.pub2.
80. Johansson BA, Berglund M, Lindgren A. Efficacy of maintenance treatment with naltrexone for opioid dependence: a meta-analytical review. Addiction. 2006;101:491-503.
81. Mattick RP, Kimber J, Breen C, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev 2009:CD002207. doi: 10.1002/14651858.CD002207.pub3.
82. Connock M, Juarez-Garcia A, Jowett S, Frew E, Liu Z, Taylor RJ. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. Health Technol Assess. 2007;11:1-171. iii-iv.
83. Ahmadi JFH, Farrashbandi H, Moosavinasab M, Babaee M, Firoozabadi A, Mohagheghzadeh M, et al. Treatment of heroin dependence. Ger J Psychiatry. 2004;7:1-5.
84. Ahmadi JMI, Ahmadi M. Treatment of intravenous buprenorphine dependence: a randomized open clinical trial. Ger J Psychiatry. 2006;6:23-9.
85. Gunne LM, Gronbladh L. The Swedish methadone maintenance program: a controlled study. Drug Alcohol Depend. 1981;7:249-56.
86. Kinlock TW, Gordon MS, Schwartz RP, Fitzgerald TT, O'Grady KE. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease. J Subst Abuse Treat. 2009;37:277-85.
87. Newman RG, Whitehill WB. Double-blind comparison of methadone and placebo maintenance treatments of narcotic addicts in Hong Kong. Lancet. 1979;2:485-8.
88. Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2003;CD002209.
89. Yancovitz SR, Des Jarlais DC, Peyser NP, Drew E, Friedmann P, Trigg HL, et al. A randomized trial of an interim methadone maintenance clinic. Am J Public Health. 1991;81:1185-91.
90. Vanichseni S, Wongsuwan B, Choopanya K, Wongpanich K. A controlled trial of methadone maintenance in a population of intravenous drug users in Bangkok: implications for prevention of HIV. Int J Addict. 1991;26:1313-20.
91. Johnson RE, Eissenberg T, Stitzer ML, Strain EC, Liebson IA, Bigelow GE. A placebo controlled clinical trial of buprenorphine as a treatment for opioid dependence. Drug Alcohol Depend. 1995;40:17-25.