Bringing Buprenorphine-Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience

References

• Office of National Drug Control Policy. National Drug Control Strategy. Washington, DC, Office of National Drug Control Policy. 2002
   Google Scholar
• Lewis JW. Buprenorphine. Drug Alcohol Depend. 1985; 14: 363–372
   PubMed Web of Science ®Google Scholar
• Johnson RE, Strain EC, Amass L. Buprenorphine: how to use it right. Drug Alcohol Depend. 2003; 70(2) (suppl). S59–S77. [CROSSREF]
   Google Scholar
• Bickel WK, Amass L. Buprenorphine treatment of opiate dependence: a review. Exp Clin Psychopharmacol. 1995; 3: 477–489. [CROSSREF]
   Web of Science ®Google Scholar
• Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994; 55: 569–580
   PubMed Web of Science ®Google Scholar
• Walsh SL, Preston KL, Bigelow GE, Stitzer ML. Acute administration of buprenorphine in humans: partial agonist and blockade effects. J Pharmacol Exp Ther. 1995; 274: 361–372
   PubMed Web of Science ®Google Scholar
• Chawarski MC, Schottenfeld RS, O'Conner PG, Pakes J.. Plasma concentrations of buprenorphine 24 to 72 hours after dosing. Drug Alcohol Depend. 1999; 55: 157–163. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Amass L, Kamien JB, Mikulich SK. Efficacy of daily and alternate-day dosing regimens with the combination buprenorphine-naloxone tablet. Drug Alcohol Depend. 2000; 58: 143–152. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Amass L, Kamien JB, Mikulich SK.. Thrice-weekly supervised dosing with the combination buprenorphine-naloxone tablet is preferred to daily supervised dosing by opioid-dependent humans. Drug Alcohol Depend. 2001; 61: 173–181. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Fudala PJ, Jaffe JH, Dax EM, Johnson RE. Use of buprenorphine in the treatment of opiate addiction: II. physiologic and behavioral effects of daily and alternate-day administration and abrupt withdrawal. Clin Pharmacol Ther. 1990; 47: 525–534
   PubMed Web of Science ®Google Scholar
• 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: 1290–1297. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Lange WR, Fudala PJ, Dax EM, Johnson RE. Safety and side effects of buprenorphine in the clinical management of heroin addiction. Drug Alcohol Depend. 1990; 26: 19–28. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Kintz P. Deaths involving buprenorphine: a compendium of French cases. Forensic Sci Int. 2001; 121: 65–69. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Kintz P.. Buprenorphine-related deaths. Kintz P, Marquet P. Buprenorphine Therapy of Opiate Addiction. Totowa, NJ, Humana Press. 2002; 109–118
   Google Scholar
• Kintz P. A new series of 13 buprenorphine-related deaths. Clin Biochem. 2002; 35: 513–516. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Jasinski DR, Pevnick JS, Griffith JD. Human pharmacology and abuse potential of the analgesic buprenorphine. Arch Gen Psychiatry. 1978; 35: 501–516
   PubMed Web of Science ®Google Scholar
• Rance MJ, Dickens JN. The influence of drug-receptor kinetics on the pharmacological and pharmaco-kinetic profiles of buprenorphine. Van Ree JM, Pereniums L. Characteristics and Function of Opioids. Amsterdam, Elsevier/North-Holland Biomedical Press. 1978; 65–66
   Google Scholar
• Amass L, Bickel WK, Higgins ST, Hughes JR. A preliminary investigation of outcome following gradual or rapid buprenorphine detoxification. J Addict Dis. 1994; 13: 33–45
   PubMed Web of Science ®Google Scholar
• Bickel WK, Amass L, Higgins ST, Badger GJ, Esch RA. Effects of adding behavioral treatment to opiate detoxification with buprenorphine. J Consult Clin Psychol. 1997; 65: 803–810. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Cheskin LJ, Fudala PJ, Johnson RE. A controlled comparison of buprenorphine and clonidine for acute detoxification from opiates. Drug Alcohol Depend. 1994; 36: 115–121. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Seow SSW, Quigley AJ, Ilett KF, et al, Buprenorphine: a new maintenance opiate?. Med J Aust. 1986; 144: 407–411
   PubMed Web of Science ®Google Scholar
• Chiang CN, Hawks R. Development of a buprenorphine-naloxone combination drug for the treatment of drug addiction [abstract]. Harris LS. Problems of Drug Dependence, NIDA Research Monograph Series, No. 141. Rockville, Md, National Institute on Drug Abuse. 1994; 458
   Google Scholar
• Chiang CN, Hawks RL. Pharmacokinetics of the combination tablet of buprenorphine and naloxone. Drug Alcohol Depend. 2003; 70(2) (suppl). S39–S47. [CROSSREF]
   PubMedGoogle Scholar
• Chiang CN, Bridge P, Hawks RL, et al, The development of buprenorphine-naloxone products for treating opiate dependence [abstract]. Harris LS. Problems of Drug Dependence, NIDA Research Monograph Series, No. 162.. Rockville, Md, National Institute on Drug Abuse. 1996; 117
   Google Scholar
• Fudala PJ, Yu E, Macfadden W, Boardman C, Chiang NC. Effects of buprenorphine and naloxone in morphine-stabilized opiate addicts. Drug Alcohol Depend. 1998; 50: 1–8. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Ahmadi J.. A controlled trial of buprenorphine treatment for opium dependence: the first experience from Iran. Drug Alcohol Depend. 2002; 66: 111–114. [CROSSREF]
   Google Scholar
• Amass L, Kamien JB, Branstetter SA, Mikulich SK. A controlled comparison of the buprenorphine-naloxone tablet and methadone for opioid maintenance treatment: interim results [abstract]. Harris LS. Problems of Drug Dependence, NIDA Research Monograph Series, No. 180. NIH Publication No. 00-4737. Washington, D.C., U.S. Government Printing Office. 2000; 161
   Google Scholar
• Fudala PJ, Bridge TP, Herbert S, et al, Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003; 349: 949–958. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Johnson RE, Jaffe JH, Fudala PJ. A controlled trial of buprenorphine treatment for opiate dependence. JAMA. 1992; 267: 2750–2755. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Kakko J, Svanborg KD, Kreek MJ, Heilig M. One-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trial. The Lancet. 2003; 361: 662–668. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Mattick RP, Ali R, White J, 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: 441–452
   PubMed Web of Science ®Google Scholar
• Pani PP, Maremmani I, Pirastu R, Tagliamonte A, Gessa GL. Buprenorphine: a controlled clinical trial in the treatment of opioid dependence. Drug Alcohol Depend. 2000; 60: 39–50. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Schottenfeld RS, Pakes JR, Oliveto A, Ziedonis D, Kosten TR. Buprenorphine versus methadone maintenance for concurrent opiate dependence and cocaine abuse. Arch Gen Psychiatry. 1997; 54: 713–720
   PubMed Web of Science ®Google Scholar
• Strain EC, Stitzer ML, Liebson IA, Bigelow GE. Comparison of buprenorphine and methadone in the treatment of opiate dependence. Am J Psychiatry. 1994; 151: 1025–1030
   PubMed Web of Science ®Google Scholar
• Pickworth WB, Johnson RE, Holicky BA, Cone EJ. Subjective and physiologic effects of intravenous buprenorphine in humans. Clin Pharmacol Ther. 1993; 53: 570–576
   PubMed Web of Science ®Google Scholar
• Strain EC, Walsh SL, Preston KL, Liebson IA, Bigelow GE. The effects of buprenorphine in buprenorphine-maintained volunteers. Psychopharmacology. 1997; 129: 329–338. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Comer SD, Collins ED, Fischman MW. Intravenous buprenorphine self-administration by detoxified heroin abusers. J Pharmacol Exp Ther. 2002; 301: 266–276. [CROSSREF]
   PubMedGoogle Scholar
• Comer SD, Collins ED. Self-administration of intravenous buprenorphine and the buprenorphine/naloxone combination by recently detoxified heroin abusers. J Pharmacol Exp Ther. 2002; 303: 695–703. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Mendelson J, Jones RT, Fernandez I, Welm S, Melby AK, Baggott MJ. Buprenorphine and naloxone interactions in opiate-dependent volunteers. Clin Pharmacol Ther. 1996; 60: 105–114
   PubMed Web of Science ®Google Scholar
• Mendelson J, Jones RT, Welm S, Melby AK, Brown J, Batki SL. Buprenorphine and naloxone interactions in methadone maintenance patients. Biol Psychiatry. 1997; 41: 1095–1101. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Mendelson J, Jones RT, Welm S, et al, Buprenorphine and naloxone combinations: the effects of three dose ratios in morphine-stabilized, opiate-dependent volunteers. Psychopharmacology. 1999; 141: 37–46. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Mendelson J, Jones RT. Clinical and pharmacological evaluation of buprenorphine and naloxone combinations: why the 4:1 ratio for treatment?. Drug Alcohol Depend. 2003; 70(2) (suppl). S29–S37. [CROSSREF]
   Google Scholar
• Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology. 2001; 154: 230–242. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Harris DS, Jones RT, Welm S, Upton RA, Lin E, Mendelson J. Buprenorphine and naloxone co-administration in opiate-dependent patients stabilized on sublingual buprenorphine. Drug Alcohol Depend. 2000; 61: 85–94. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Strain EC, Stoller K, Walsh SL, Bigelow GE.. Effects of buprenorphine versus buprenorphine/naloxone tablets in non-dependent opioid abusers. Psychopharmacology. 2000; 148: 374–383. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Amass L, Kamien JB, Reiber C, Branstetter SA. Abuse liability of IV buprenorphine-naloxone, buprenorphine and hydromorphone in buprenorphine-naloxone maintained volunteers. Drug Alcohol Depend. 2000; 60: S6
   Google Scholar
• Jaffe JH, O'Keeffe CO. From morphine clinics to buprenorphine: regulating opioid agonist treatment of addiction in the United States. Drug Alcohol Depend. 2003; 70(2) (suppl). S3–S11. [CROSSREF]
   PubMedGoogle Scholar
• Drug Addiction Treatment Act, 42 USC§3502a. 2000
   Google Scholar
• Boatwright DE. Buprenorphine and addiction: challenges for the pharmacist. Journal of American Pharmacological Association. 2002; 42: 432–438. [CROSSREF]
   Google Scholar
• Fiellin DA, O'Connor PG. New federal initiatives to enhance the medical treatment of opioid dependence. Ann Intern Med. 2002; 137: 688–692
   PubMed Web of Science ®Google Scholar
• Hanson GR, Leshner AI, Tai B. Putting drug abuse research to use in real-life settings. J Subst Abuse Treat. 2002; 23: 69–70. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Gold MS, Pottash AC, Sweeney DR, Kleber HD. Opiate withdrawal using clonidine. a safe, effective and rapid nonopiate treatment. JAMA. 1980; 243: 343–346. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Charney DS, Sternberg DE, Kleber HD, Heninger GR, Redmond DE. The clinical use of clonidine in abrupt withdrawal from methadone: effects on blood pressure and specific signs and symptoms. Arch Gen Psychiatry. 1981; 38: 273–277
   Google Scholar
• Gossup M. Clonidine and the treatment of the opiate withdrawal syndrome. Drug Alcohol Depend. 1988; 21: 253–259. [CROSSREF]
   Google Scholar
• Rounsaville BJ, Kosten T, Kleber H. Success and failure at outpatient opioid detoxification: evaluating the process of clonidine- and methadone-assisted withdrawal. J Nerv Ment Dis. 1985; 173: 103–110
   PubMed Web of Science ®Google Scholar
• Ling W, Obert JL. Handbook for Recovery from Opiate Dependence, Adapted from:The Matrix Model. Vers. 1. 16th Nov. 2000
   Google Scholar
• Hudziak J, Helzer JE, Wetzel MW, et al, The use of the DSM-III-R checklist for initial diagnostic assessments. Compr Psychiatry. 1993; 34: 375–383. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• McLellan AT, Luborsky L, Cacciola J, et al, New data from the Addiction Severity Index: reliability and validity in three centers. J Nerv Ment Dis. 1985; 173: 412–423
   PubMed Web of Science ®Google Scholar
• Wesson D, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs.. 2003; 35: 253–259
   PubMed Web of Science ®Google Scholar
• Bickel WK, Stitzer MI, Bigelow GE, Liebson IA, Jasinski DR, Johnson RE. A clinical trial of buprenorphine: comparison with methadone in the detoxification of heroin addicts. Clin Pharmacol Ther. 1988; 43: 72–78
   PubMed Web of Science ®Google Scholar
• Bickel WK, Stitzer MI, Bigelow GE, Liebson IA, Jasinski DR, Johnson RE. Buprenorphine: dose-related blockade of opioid challenge effects in opioid-dependent humans. J Pharmacol Exp Ther. 1988; 247: 47–53
   PubMed Web of Science ®Google Scholar
• Johnson RE, Eissenberg T, Stitzer ML, Strain EC, Liebson IA, Bigelow GE. A placebo-controlled clinical trial of buprenorphine as a treatment for opiate dependence. Drug Alcohol Depend. 1995; 40: 17–25. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• O'Connor PG, Oliveto AH, Shi JM, et al, A randomized trial of buprenorphine maintenance for heroin dependence in a primary care clinic for substance users versus a methadone clinic. Am J Med. 1998; 105: 100–105. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Ling W, Wesson DR, Charuvastra C, Klett CJ. A controlled trial comparing buprenorphine and methadone maintenance in opiate dependence. Arch Gen Psychiatry. 1996; 54: 401–407
   Google Scholar
• Ling W, Charuvastra C, Collins JF. Buprenorphine maintenance treatment of opiate dependence: a multicenter, randomized clinical trial. Addiction. 1998; 93: 475–486. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Uehlinger C, Déglon J-J, Livoti S, Petitjean S S, Waldvogel D, Ladewing D. Comparison of buprenorphine and methadone in the treatment of opioid dependence. Eur. Addict Res. 1998; 4: 13–18. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Fischer G, Gombas W, Eder H, et al, Buprenorphine versus methadone maintenance for the treatment of opioid dependence. Addiction. 1999; 94: 337–347
   Google Scholar
• Petitjean S, Stohler R, Deglon J-J. Double-blind randomized trial of buprenorphine and methadone in opiate dependence. Drug Alcohol Depend. 2001; 62: 97–104
   Google Scholar
• Clinical Guidelines for Buprenorphine Treatment. Rockville, Md, Center for Substance Abuse Treatment Administration; Forthcoming. Treatment Improvement Protocol Series
   Google Scholar
• Law FD, Bailey JE, Allen DS, et al, The feasibility of abrupt methadone-buprenorphine transfer in British opiate addicts in an outpatient setting. Addict Biol. 1997; 2: 191–200. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Bouchez J, Beauverie P, Touzeau D.. Substitution with buprenorphine in methadone- and morphine sulfate-dependent patients. Eur Addict Res. 1998; 4: 8–12. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Seifert L, Metzner C, Paetzold W, et al, Detoxification of opiate addicts with multiple drug abuse: a comparison of buprenorphine and methadone. Pharmacopsychiatry. 2002; 35: 159–164. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Vignau J. Preliminary assessment of a 10-day rapid detoxification programme using high dosage buprenorphine. Eur Addict Res. 1998; 4: 29–31. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Lintzeris N, Bell J, Bammer G, Jolley D, Rushworth L. A randomized controlled trial of buprenorphine in the management of short-term ambulatory heroin withdrawal. Addiction. 2002; 97: 1395–1404. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Reynaud M, Tracqui A, Petit G, Potard D, Courty P. Six deaths linked to misuse of buprenorphine-benzodiazepine combinations. Am J Psychiatry. 1998; 155: 448–449
   PubMed Web of Science ®Google Scholar
• Tracqui A, Kintz P, Ludes B. Buprenorphine-related deaths among drug addicts in France: a report on 20 fatalities. J Anal Toxicol. 1998; 22: 430–434
   PubMed Web of Science ®Google Scholar
• Tracqui A, Tournoud C, Flesch F, et al, Buprenorphine poisoning in drug abusers on substitution therapy: 29 non-fatal and 20 fatal cases. La Presse Md. 1998; 27: 557–561
   PubMed Web of Science ®Google Scholar
• Walsh SL, June HL, Schuh KJ, Preston KL, Bigelow GE, Stitzer ML. Effects of buprenorphine and methadone in methadone-maintained subjects. Psychopharmacology. 1995; 119: 268–276
   PubMed Web of Science ®Google Scholar
• Strain EC, Preston KL, Liebson IA, Bigelow GE. Buprenorphine effects in methadone-maintained volunteers: effects at two hours after methadone. J Pharmacol Exp Ther. 1995; 272: 628–638
   PubMed Web of Science ®Google Scholar
• Amass L. Bringing buprenorphine to community providers: the NIDA Clinical Trials Network experience [abstract]. Amass L, Ling W, Ready, set, go: bringing buprenorphine to the U.S. treatment market. Harris LS. Problems of Drug Dependence, NIDA Research Monograph Series, No. 182. NIH Publication No. 02-5097. Washington, D.C., U.S. Government Printing Office. 2002; 27–37
   Google Scholar
• Ling W, Smith D. Buprenorphine: blending practice and research. J Subst Abuse Treat. 2002; 23: 87–92. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Ball JC, Ross A. The Effectiveness of Methadone Maintenance Treatment. New York, Springer-Verlag. 1991
   Google Scholar
• Hser YI, Hoffman V, Grella CE, Anglin MD. A 33-year follow-up of narcotics addicts. Arch Gen Psychiatry. 2001; 58: 503–508. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Ling W, Amass L. Bupenorphine-naloxone and clonidine for short-term opioid withdrawal: results from the NIDA Clinical Trials Network multi site evaluation. Forthcoming.
   Google Scholar
• Agar M, Bourgois P, French J, Murdoch O. Buprenorphine: field trials of a new drug. Qualitative Health Research. 2001; 11: 69–84. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• McLellan AT, Arndt IO, Metzger DS, Woody GE, O'Brien CP. The effects of psychosocial services in substance abuse treatment. JAMA. 1993; 269: 1953–1959. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Sees KL, Delucchi KL, Masson C, et al, JAMA. JAMA. 2000; 283: 1303–1310. [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Gossop M, Green L, Phillips G, Bradley B. Lapse, relapse, and survival among opiate addicts after treatment: a prospective follow-up study. Br J Psychiatry. 1989; 154: 348–353
   PubMed Web of Science ®Google Scholar
• Hser YI, Yamaguchi K, Chen J, Anglin MD. Effects of interventions on relapse to narcotics addiction: an event-history analysis. Evolutional Review. 1995; 19: 123–140
   Web of Science ®Google Scholar
• McLellan AT, Lewis DC, O'Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000; 284: 1689–1695. [CROSSREF]
   PubMed Web of Science ®Google Scholar