Long-acting injectable naltrexone for the treatment of alcohol dependence

References

• McKenna MT, Michaud CM, Murray CJ et al. Assessing the burden of disease in the United States using disability-adjusted life years. Am. J. Prev. Med.28, 415–423 (2005).
   PubMed Web of Science ®Google Scholar
• Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, Pickering RP. The 12-month prevalence and trends in DSM-IV alcohol abuse and dependence: United States, 1991–1992 and 2001–2002. Drug Alcohol Depend.74, 223–234 (2004).
   PubMed Web of Science ®Google Scholar
• Saitz R. Clinical practice. Unhealthy alcohol use. N. Engl. J. Med.352, 596–607 (2005)
   PubMed Web of Science ®Google Scholar
• Finney JW, Hahn AC, Moos RH. The effectiveness of inpatient and outpatient treatment for alcohol abuse: the need to focus on mediators and moderators of setting effects. Addiction91, 1773–1796 (1996).
   PubMed Web of Science ®Google Scholar
• Miller WR, Walters ST, Bennett ME. How effective is alcoholism treatment in the United States? J. Stud. Alcohol.62(2), 211–220 (2001).
   PubMed Web of Science ®Google Scholar
• Marlatt GA, Witkiewitz K. Harm reduction approaches to alcohol use: health promotion, prevention, and treatment. Addict. Behav.27, 867–886 (2002).
   PubMed Web of Science ®Google Scholar
• Dawson DA, Grant BF, Stinson FS, Chou PS, Huang B, Ruan WJ. Recovery from DSM-IV alcohol dependence: United States, 2001–2002. Addiction100(3), 281–292 (2005).
   PubMed Web of Science ®Google Scholar
• Kranzler HR, Van Kirk J. Efficacy of naltrexone and acamprosate for alcoholism treatment: a meta-analysis. Alcohol. Clin. Exp. Res.25, 1335–1341 (2001).
   PubMed Web of Science ®Google Scholar
• Berglund M, Thelander S, Salaspuro M, Franck J, Andreasson S, Ojehagen A. Treatment of alcohol abuse. Alcohol. Clin. Exp. Res.27, 1645–1656 (2003).
   PubMed Web of Science ®Google Scholar
• Mason BJ. Acamprosate and naltrexone treatment for alcohol dependence. Eur. Neuropsychopharmacol.13, 469–475 (2003).
   PubMed Web of Science ®Google Scholar
• Mark TL, Kranzler HR, Poole VH, Hagen CA, McLeod C, Crosse S. Barriers to the use of medications to treat alcoholism. Am. J. Addict.12(4), 281–294 (2003).
   PubMed Web of Science ®Google Scholar
• Anton RF, O’Malley SS, Ciraulo DA et al. COMBINE Study Research Group. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA295, 2003–2017 (2006).
   PubMed Web of Science ®Google Scholar
• Krystal JH, Cramer JA, Krol WF, Kirk GF, Rosenheck RA. Veterans Affairs. Naltrexone Cooperative Study 425 Group. N. Engl. J. Med.345, 1734–1739 (2001).
   PubMed Web of Science ®Google Scholar
• Monti PM, Rohsenow DJ, Swift RM et al. Naltrexone and cue exposure with coping and communication skills training for alcoholics: treatment process and 1-year outcomes. Alcohol. Clin. Exp. Res.25, 1634–1647 (2001).
   PubMed Web of Science ®Google Scholar
• Chick J, Anton R, Checinski K et al. A multicentre, randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of alcohol dependence or abuse. Alcohol Alcohol.35, 587–593 (2000).
   PubMed Web of Science ®Google Scholar
• Volpicelli JR, Rhines KC, Rhines JS, Volpicelli LA, Alterman AI, O’Brien CP. Naltrexone and alcohol dependence. Role of subject compliance. Arch. Gen. Psychiatry54, 737–742 (1997).
   PubMed Web of Science ®Google Scholar
• Cox WM, Blount JP, Crowe PA, Singh SP. Diabetic patients’ alcohol use and quality of life: relationships with prescribed treatment compliance among older males. Alcohol. Clin. Exp. Res.20(2), 327–331 (1996).
   PubMed Web of Science ®Google Scholar
• Fuller RK, Branchey L, Brightwell DR et al. Disulfiram treatment of alcoholism. A Veterans Administration cooperative study. JAMA256, 1449–1455 (1986).
   PubMed Web of Science ®Google Scholar
• Oslin DW, Berrettini W, Kranzler HR et al. A functional polymorphism of the μ-opioid receptor gene is associated with naltrexone response in alcohol-dependent patients. Neuropsychopharmacology28, 1546–1552 (2003).
   PubMed Web of Science ®Google Scholar
• Oslin DW, Berrettini WH, O’Brien CP. Targeting treatments for alcohol dependence: the pharmacogenetics of naltrexone. Addict. Biol.11, 397–403 (2006).
   PubMed Web of Science ®Google Scholar
• Croop RS, Faulkner EB, Labriola DF. The safety profile of naltrexone in the treatment of alcoholism. Results from a multicenter usage study. The Naltrexone Usage Study Group. Arch. Gen. Psychiatry54, 1130–1135 (1997).
   PubMed Web of Science ®Google Scholar
• Rohsenow DJ, Colby SM, Monti PM et al. Predictors of compliance with naltrexone among alcoholics. Alcohol. Clin. Exp. Res.24(10), 1542–1549 (2000).
   PubMed Web of Science ®Google Scholar
• Anton RF, Swift RM. Current pharmacotherapies of alcoholism: a US perspective. Am. J. Addict.12(Suppl. 1), S53–S68 (2003).
   Web of Science ®Google Scholar
• Kranzler HR, Wesson DR, Billot L. DrugAbuse Sciences Naltrexone Depot Study Group. Naltrexone depot for treatment of alcohol dependence: a multicenter, randomized, placebo-controlled clinical trial. Alcohol. Clin. Exp. Res.28, 1051–1059 (2004).
   PubMed Web of Science ®Google Scholar
• Harris KM, Thomas C. Naltrexone and pharmacy benefit management. J. Addict. Dis.23, 11–29 (2004).
   PubMed Web of Science ®Google Scholar
• Meyer RE. Prospects for a rational pharmacotherapy of alcoholism. J. Clin. Psychiatry50, 403–412 (1989).
   PubMed Web of Science ®Google Scholar
• Adams CE, Fenton MK, Quraishi S, David AS. Systematic meta-review of depot antipsychotic drugs for people with schizophrenia. Br. J. Psychiatry179, 290–299 (2001).
   PubMed Web of Science ®Google Scholar
• Kane JM, Leucht S, Carpenter D, Docherty JP. Expert Consensus Panel for Optimizing Pharmacologic Treatment of Psychotic Disorders. The expert consensus guideline series. Optimizing pharmacologic treatment of psychotic disorders. Introduction: methods, commentary, and summary. J. Clin. Psychiatry64, 5–19 (2003).
   PubMed Web of Science ®Google Scholar
• Kranzler HR, Koob G, Gastfriend DR, Swift RM, Willenbring ML. Advances in the pharmacotherapy of alcoholism: challenging misconceptions. Alcohol. Clin. Exp. Res.30(2), 272–281 (2006).
   PubMedGoogle Scholar
• Oswald LM, Wand GS. Opioids and alcoholism. Physiol. Behav.81, 339–358 (2004).
   PubMed Web of Science ®Google Scholar
• Johnson BA, Ait-Daoud N, Aubin HJ, et al. A pilot evaluation of the safety and tolerability of repeat dose administration of long-acting injectable naltrexone (Vivitrex) in patients with alcohol dependence. Alcohol. Clin. Exp. Res.28, 1356–1361 (2004).
   PubMed Web of Science ®Google Scholar
• Schmidt WK, Tam SW, Shotzberger GS, Smith DH Jr, Clark R, Vernier VG. Nalbuphine. Drug Alcohol Depend.14, 339–362 (1985).
   PubMed Web of Science ®Google Scholar
• Stromberg MF, Casale M, Volpicelli L, Volpicelli JR, O’Brien CP. A comparison of the effects of the opioid antagonists naltrexone, naltrindole, and β-funaltrexamine on ethanol consumption in the rat. Alcohol15, 281–289 (1998).
   PubMed Web of Science ®Google Scholar
• Lee MC,Wagner HN, Tanada S, Frost JJ, Bice AN, Dannals RF. Duration of occupancy of opiate receptors by naltrexone. J. Nucl. Med.29, 1207–1211 (1988).
   PubMed Web of Science ®Google Scholar
• McCaul ME, Kim WK, Wand GS, Bencherif B, Dannals RF, Frost JJ. PET Measurement of µ- and d-opioid receptor availability before and during naltrexone treatment in alcohol dependent subjects (poster). Presented at: The Winter Conference on Brain Research. Copper Mountain, CO, USA, 24–30 January 2004.
   Google Scholar
• Wall ME, Brine DR, Perez-Reyes M. The metabolism of naltrexone in man. NIDA Res. Monogr.28, 105–31 (1981).
   PubMedGoogle Scholar
• Brewer C. Naltrexone implants for opiate addiction: new life for a middle-aged drug. Pharm. J.26(7), 162 (2001).
   Google Scholar
• Bartus RT, Emerich DF, Hotz J et al. Vivitrex, an injectable, extended-release formulation of naltrexone, provides pharmacokinetic and pharmacodynamic evidence of efficacy for 1 month in rats. Neuropsychopharmacology28, 1973–1982 (2003).
   PubMed Web of Science ®Google Scholar
• Dunbar JL, Turncliff RZ, Dong Q, Silverman BL, Ehrich EW, Lasseter KC. Single- and multiple-dose pharmacokinetics of long-acting injectable naltrexone. Alcohol. Clin. Exp. Res.30, 480–490 (2006).
   PubMed Web of Science ®Google Scholar
• Lewis DH Controlled release of bioactive agents from lactide/glycolide polymers. In:Biodegradable Polymers as Drug Delivery Systems.Chasin M, Langer R (Eds). Marcel Dekker, NY, USA 1–41 (1990).
   Google Scholar
• Dean RL. The preclinical development of Medisorb Naltrexone, a once a month long acting injection, for the treatment of alcohol dependence. Front. Biosci.10, 643–655 (2005).
   PubMed Web of Science ®Google Scholar
• Turncliff RZ, Dunbar JL, Dong Q. Pharmacokinetics of long-acting naltrexone in subjects with mild to moderate hepatic impairment. J. Clin. Pharmacol.45, 1259–1267 (2005).
   PubMed Web of Science ®Google Scholar
• McCaul ME, Wand GS, Rohde C, Lee SM. Serum 6-β-naltrexol levels are related to alcohol responses in heavy drinkers. Alcohol. Clin. Exp. Res.24, 1385–1391 (2000).
   PubMed Web of Science ®Google Scholar
• King AC, Volpicelli JR, Gunduz M, O’Brien CP, Kreek MJ. Naltrexone biotransformation and incidence of subjective side effects: a preliminary study. Alcohol. Clin. Exp. Res.21(5), 906–909 (1997).
   PubMed Web of Science ®Google Scholar
• Ciraulo D, Pettinati HM. Early onset of effect of injectable extended-release naltrexone (XR-NTX) pharmacotherapy for alcohol dependence. Presented at: 37th Annual Meeting of the American Society for Addiction Medicine. San Diego, CA, USA, 4–7 May 2006.
   Google Scholar
• Bohn M, Gastfriend DR, Dong Q, Silverman B. Day-off-the-week drinking variabililty in alcohol-dependent patients and efficacy of pharmacotherapy with extended-release naltrexone (XR-NTX). Presented at: 159th Annual Meeting of the American Psychiatric Association. Toronto, ON, Canada, 20–25 May 2006.
   Google Scholar
• Kranzler HR, Modesto-Lowe V, Nuwayser ES. Sustained-release naltrexone for alcoholism treatment: a preliminary study. Alcohol. Clin. Exp. Res.22(5), 1074–1079 (1998).
   PubMed Web of Science ®Google Scholar
• Garbutt JC, Kranzler HR, O’Malley SS et al. Efficacy and tolerabitlity of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA295, 1617–1625 (2005).
   Google Scholar
• Kiefer F, Jahn H, Wiedemann K. A neuroendocrinological hypothesis on gender effects of naltrexone in relapse prevention treatment. Pharmacopsychiatry38, 184–186 (2005).
   PubMed Web of Science ®Google Scholar
• O’Malley SS, Jaffe AJ, Chang G, Schottenfeld RS, Meyer RE, Rounsaville B. Naltrexone and coping skills therapy for alcohol dependence. A controlled study. Arch. Gen. Psychiatry49, 881–887 (1992).
   PubMed Web of Science ®Google Scholar
• O’Malley SS, Illepuruma A, Loewy J, Ehrich E, Silverman B. Effects of lead-in drinking/treatment goal with long-acting naltrexone. Presented at: 158th Annual Meeting of the American Psychiatric Association. Atlanta, GA, USA, 21–26 May 2005.
   Google Scholar
• Gastfriend DR, Dong Q, Loewy J, Silverman B, Ehrich E. Durability of effect of long-acting injectable naltrexone. Presented at: 158th Annual Meeting of the American Psychiatric Association. Atlanta, GA, USA, 21–26 May 2005.
   Google Scholar
• Galloway GP, Koch M, Cello R, Smith DE. Pharmacokinetics, safety, and tolerability of a depot formulation of naltrexone in alcoholics: an open-label trial. BMC Psychiatry1, 5–18 (2005).
   Google Scholar
• Martin PR, Loewy J, Liou S, Silverman B, Ehrich E. Serum gamma-glutamyl transferase levels correlate with alcohol consumption. Presented at: 158th Annual Meeting of the American Psychiatric Association. Atlanta, GA, USA, 21–26 May 2005.
   Google Scholar
• Silverman B, Lucey MR, Illepuruma A, O’Brien CP. Hepatic safety of once-monthly, extended-release intramuscular naltrexone (XR-NTX) in alcohol/mixed/opiate-dependent patients: a pooled analysis from two clinical studies. Presented at: 159th Annual meeting of the American Psychiatric Association. Toronto, Canada, 20–25 May 2006.
   Google Scholar
• Johnson BA, O’Malley SS, Ciraulo DA et al. Dose-ranging kinetics and behavioral pharmacology of naltrexone and acamprosate, both alone and combined, in alcohol-dependent subjects. J. Clin. Psychopharmacol.23, 281–293 (2003).
   PubMed Web of Science ®Google Scholar
• Zweben A, Gastfriend DR, Loewy J, Silverman B, Ehrich E. Participation in counseling and recovery activities during pharmacotherapy with injectable long-acting naltrexone. Presented at: AAAP 16th Annual Meeting and Symposium. Scottsdale, AZ, USA, 8–11 December 2005.
   Google Scholar
• Kranzler H, Liou S, Loewy J, Silverman B, Ehrich E. Effect of long-acting injectable naltrexone on quality of life. Presented at: 158th Annual Meeting of the American Psychiatric Association. Atlanta, GA, USA, 21–26 May 2005.
   Google Scholar
• Balldin J, Berglund M, Borg S et al. A 6-month controlled naltrexone study: combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence. Alcohol. Clin. Exp. Res.27, 1142–1149 (2003).
   PubMed Web of Science ®Google Scholar
• O’Malley SS, Rounsaville BJ, Farren C et al. Initial and maintenance naltrexone treatment for alcohol dependence using primary care versus specialty care: a nested sequence of 3 randomized trials. Arch. Intern. Med.163(14), 1695–1704 (2003).
   PubMed Web of Science ®Google Scholar
• Bouza C, Magro A, Munoz A, Amate JM. Efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence: a systematic review. Addiction99, 811–828 (2004).
   PubMed Web of Science ®Google Scholar
• Srisupanont M, Jarusiraisin N. Opioid antagonists for alcohol dependence: a review. Cochrane Database Syst. Rev.25(1), CD001867 (2005).
   Google Scholar
• Cookson J, Gilaberte I, Desaiah D, Kajdasz DK. Treatment benefits of duloxetine in major depressive disorder as assessed by number needed to treat. Int. Clin. Psychopharmacol.21(5), 267–273 (2006).
   PubMed Web of Science ®Google Scholar
• Kraemer HC, Morgan GA, Leech NL, Gliner JA, Vaske JJ, Harmon RJ. Measures of clinical significance. J. Am. Acad. Child Adolesc. Psychiatry42, 1524–1529 (2003).
   PubMed Web of Science ®Google Scholar
• Kim SW, Grant JE, Adson DE, Remmel RP. A preliminary report on possible naltrexone and nonsteroidal analgesic interactions. J. Clin. Psychopharmacol.21(6), 632–634 (2001).
   PubMedGoogle Scholar
• Kim SW, Grant JE, Yoon G, Williams KA, Remmel RP. Safety of high-dose naltrexone treatment: hepatic transaminase profiles among outpatients. Clin. Neuropharmacol.29(2), 77–79 (2006).
   PubMed Web of Science ®Google Scholar
• Roozen HG, de Waart R, van der Windt DA, van den Brink W, de Jong CA, Kerkhof AJ. A systematic review of the effectiveness of naltrexone in the maintenance treatment of opioid and alcohol dependence. Eur. Neuropsychopharmacol.16, 311–323 (2006).
   PubMed Web of Science ®Google Scholar
• Oncken C, Van Kirk J, Kranzler HR. Adverse effects of oral naltrexone: analysis of data from two clinical trials. Psychopharmacology154, 397–402 (2001).
   PubMed Web of Science ®Google Scholar
• The Cytochrome P450 System: Drug Interaction Principles for Medical Practice.Cozza KL, Armstrong SC (Eds). American Psychiatric Publishing, VA, USA (2001).
   Google Scholar
• Comer SD, Sullivan MA, Yu E et al. Injectable, sustained-release naltrexone for the treatment of opioid dependence: a randomized, placebo-controlled trial. Arch. Gen. Psychiatry63, 210–218 (2006).
   PubMed Web of Science ®Google Scholar
• Sullivan MA, Vosburg SK, Comer SD. Depot naltrexone: antagonism of the reinforcing, subjective, and physiological effects of heroin. Psychopharmacology189, 37–46 (2006).
   PubMed Web of Science ®Google Scholar
• De Giacomo M, Gaspari R, Stefanelli A et al. Emergency therapeutical approach simulating ultrarapid opioid detoxification in methadone withdrawal precipitated by erroneous administration of naltrexone. Eur. J. Emerg. Med.6(2), 153–155 (1999).
   PubMedGoogle Scholar
• O’Brien B, Cody C. Analgesia and sedation in the presence of a naltrexone implant: a novel pharmacological challenge. Eur. J. Emerg. Med.13, 315–316 (2006).
   PubMedGoogle Scholar
• McQuay H, Moore A. An evidence-based resource for pain relief. Oxford University Press, Oxford, UK 78–83 (1998).
   Google Scholar
• Piguet V, Desmeules J, Dayer P. Lack of acetaminophen ceiling effect on R-III nociceptive flexion reflex. Eur J. Clin. Pharmacol.53, 321–324 (1998).
   PubMed Web of Science ®Google Scholar
• Vickers AP, Jolly A. Naltrexone and problems in pain management. BMJ332, 132–133 (2006).
   PubMedGoogle Scholar
• Raith K, Hochhaus G. Drugs used in the treatment of opioid tolerance and physical dependence: a review. Int. J. Clin. Pharmacol. Ther.42, 191–203 (2004).
   PubMedGoogle Scholar
• Todtenkopf MS, Dean R, Deaver D et al. Analgesic actions of fentanyl and hydrocodone in rats treated with extended-release naltrexone. Presented at: 45th Annual Meeting of the American College of NeuroPsychopharmacology. Hollywood, FL, USA, 3–7 December 2006.
   Google Scholar
• Hughes DA. Less is more: medicines that require less frequent administration improve adherence, but are they better? Pharmacoeconomics24, 211–213 (2006).
   PubMed Web of Science ®Google Scholar
• Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin. Ther.23, 1296–1310 (2001).
   PubMed Web of Science ®Google Scholar
• Siegel SJ. Extended release drug delivery strategies in psychiatry; theory to practice. Psychiatry2, 22–23 (2005).
   PubMedGoogle Scholar
• Starosta AN, Leeman RF, Volpicelli JR. The BRENDA model: integrating psychosocial treatment and pharmacotherapy for the treatment of alcohol use disorders. J. Psychiatr. Pract.12, 80–89 (2006).
   PubMedGoogle Scholar
• Ducharme LJ, Knudsen HK, Roman PM. Trends in the adoption of medications for alcohol dependence. J. Clin. Psychopharmacol.26, S13–S19 (2006).
   PubMedGoogle Scholar
• Kirchmayer U, Davoli M, Verster AD, Amato L, Ferri M, Perucci CA. A systematic review on the efficacy of naltrexone maintenance treatment in opioid dependence. Addiction97, 1241–1249 (2002).
   PubMed Web of Science ®Google Scholar
• Collins ED, Kleber HD, Whittington RA, Heitler NE. Anesthesia-assisted vs buprenorphine- or clonidine-assisted heroin detoxification and naltrexone induction: a randomized trial. JAMA294(8), 903–913 (2005).
   PubMed Web of Science ®Google Scholar
• Gerra G, Fantoma A, Zaimovic A. Naltrexone and buprenorphine combination in the treatment of opioid dependence. J. Psychopharmacol.20(6), 806–814 (2006).
   PubMed Web of Science ®Google Scholar
• Grant JE, Brewer JA, Potenza MN. The neurobiology of substance and behavioral addictions. CNS Spectr.11(12), 924–930 (2006).
   PubMed Web of Science ®Google Scholar
• Kim SW. Opioid antagonists in the treatment of impulse-control disorders. J. Clin. Psychiatry59(4), 159–164 (1998).
   PubMed Web of Science ®Google Scholar
• Kim SW, Grant JE, Adson DE, Shin YC. Double-blind naltrexone and placebo comparison study in the treatment of pathological gambling. Biol. Psychiatry49(11), 914–921 (2001).
   PubMed Web of Science ®Google Scholar
• Grant JE, Kim SW. An open-label study of naltrexone in the treatment of kleptomania. J. Clin. Psychiatry63(4), 349–356 (2002).
   PubMed Web of Science ®Google Scholar
• Godart NT, Agman G, Perdereau F, Jeammet P. Naltrexone treatment of self-injurious behavior. J. Am. Acad. Child Adolesc. Psychiatry.39(9), 1076–1078 (2000).
   PubMedGoogle Scholar
• Jarosz PA, Metzger BL. The effect of opioid antagonism on food intake behavior and body weight in a biobehavioral model of obese binge eating. Biol. Res. Nurs.3(4), 198–209 (2002).
   PubMedGoogle Scholar
• Lima MS, Moncrieff J. Drugs vs placebo for dysthymia. Cochrane Database Syst. Rev.4, CD001130 (2000).
   Google Scholar
• Storosum JG, Elferink AJ, van Zwieten BJet al. Short-term efficacy of tricyclic antidepressants revisited: a meta-analytic study. Eur. Neuropsychopharmacol.11, 173–180 (2001).
   PubMed Web of Science ®Google Scholar
• Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir. Care45, 1200–1262 (2000).
   PubMedGoogle Scholar
• West R, McNeill A, Raw M. Smoking cessation guidelines for health professionals: an update. Health Education Authority. Thorax55, 987–999 (2000).
   PubMed Web of Science ®Google Scholar
• Mark TL, Swait J. Using stated preference and revealed preference modeling to evaluate prescribing decisions. Health Econ.13, 563–573 (2004).
   PubMed Web of Science ®Google Scholar
• Cohen J. In: Statitstical Power Analyses for the Social Science. Lawerence, Erlbaum & Associates, NY, USA (1998).
   Google Scholar