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51. Efficacy of Naltrexone Treatment
"Studies conducted in St. Petersburg, Russia, for more than a decade have demonstrated the efficacy and safety of different naltrexone formulations (oral, implantable, injectable) for relapse prevention and maintenance of abstinence in detoxified opioid addicts. The positive results from different formulations seem related to two cultural factors. One is that relatives can be recruited to supervise daily dosing of the oral formulation. However, this advantage is decreasing as the addicted population ages. The second is that substitution therapy is not available; thus, naltrexone is the only effective medication available, which makes it easier to motivate patients to use it. Preliminary findings from studies of long-acting, slow-release formulations of naltrexone (implantable and injectable) suggest that they are more effective than the oral formulations and are likely to be important additions to current treatments. How they compare with maintenance treatment using methadone or buprenorphine in settings in which these three treatment options are available is a topic for future studies."
Krupitsky, Evgeny, Zvartau, Edwin, and Woody, George, "Use of Naltrexone to Treat Opioid Addiction in a Country in Which Methadone and Buprenorphine Are Not Available," Curr Psychiatry Rep. 2010 October; 12(5): 448–453. doi:10.1007/s11920-010-0135-5.
52. Methadone Mortality and Pain Medicine
"Taken together, the data confirm a correlation between increased methadone distribution through pharmacy channels and the rise in methadone-associated mortality. The data, thus, support the hypothesis that the growing use of oral methadone, prescribed and dispensed for the outpatient management of pain, explains the dramatic increases in methadone consumption and the growing availability of the drug for diversion to illicit use. Although the data remain incomplete, National Assessment meeting participants concurred that methadone tablets and/or diskettes distributed through channels other than OTPs most likely are the central factor in methadone-associated mortality."
Center for Substance Abuse Treatment, "Methadone-Associated Mortality: Report of a National Assessment," May 8-9, 2003, CSAT Publication No. 28-03 (Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 2004), p. 25.
53. Methadone - 3-11-10
"The current narcotic treatment system is able to provide the most effective medical treatment for opioid dependence, opioid agonist maintenance, to only 170,000 of the estimated 810,000 opioid-dependent individuals in the United States."
Fiellin, David A., MD, Patrick G. O'Connor, MD, MPH, Marek Chawarski, PhD, Juliana P. Pakes, MEd, Michael V. Pantalon, PhD, and Richard S. Schottenfeld, MD, "Methadone Maintenance in Primary Care: A Randomized Controlled Trial," Journal of the American Medical Association (Chicago, IL: American Medical Association, Oct. 10, 2001), Vol. 286, No. 14, p. 1724.
54. Cost of Untreated Opioid Dependence
"The financial costs of untreated opiate dependence to the individual, the family, and society are estimated to be approximately $20 billion per year."
National Institutes of Health, Office of the Director, "NIH Consensus Statement: Effective Medical Treatment of Opiate Addiction," (U.S. Department of Health: Bethesda, MD, November 1997) Vol. 15, No. 6, p. 11.
55. Buprenorphine Approval by FDA
"Federal statute, the Drug Addiction Treatment Act of 2000 (DATA 2000), has established a new paradigm for the medication-assisted treatment of opioid addiction in the United States (Drug Addiction Treatment Act of 2000). Prior to the enactment of DATA 2000, the use of opioid medications to treat opioid addiction was permissible only in federally approved Opioid Treatment Programs (OTPs) (i.e., methadone clinics), and only with the Schedule II opioid medications methadone and levo-alpha-acetyl-methadol (LAAM), which could only be dispensed, not prescribed.* Now, under the provisions of DATA 2000, qualifying physicians in the medical office and other appropriate settings outside the OTP system may prescribe and/or dispense Schedule III, IV, and V opioid medications for the treatment of opioid addiction if such medications have been specifically approved by the Food and Drug Administration (FDA) for that indication. (The text of DATA 2000 can be viewed at http://www.buprenorphine.samhs....) [NOTE: as of January 2019 that link was no longer valid. The new URL is https://www.ncbi.nlm.nih.gov/b...
"In October 2002, FDA approved two sublingual formulations of the Schedule III opioid partial agonist medication buprenorphine for the treatment of opioid addiction. These medications, Subutex® (buprenorphine) and Suboxone® (buprenorphine/naloxone), are the first and, as of this writing, the only Schedule III, IV, or V medications to have received such FDA approval and, thus, to be eligible for use under DATA 2000."
Center for Substance Abuse Treatment. "Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction." Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004, p. xv.
56. Buprenorphine Formulation
"Buprenorphine is a long-acting partial opioid agonist91,92 that is classified as a Schedule III narcotic, in contrast to methadone and levomethadyl, which are Schedule II. Its potential advantages include a higher degree of safety than with methadone, coupled with an ameliorated withdrawal syndrome. This is due to its partial agonist property at the ?-receptor along with its being a weak antagonist at the k-receptor.93-95 It is available in a tablet form for sublingual administration and in parenteral form. Buprenorphine is metabolized through the cytochrome P450 pathway.96-97 The brand name for the buprenorphine monotablet is Subutex, and the combination buprenorphine hydrochloride–naloxone hydrochloride tablet is Suboxone (both Reckitt Benckiser Pharmaceuticals, Richmond, Va). Both formulations come in strengths of 2 and 8 mg. The combination product contains 0.5mg of the opioid antagonist naloxone hydrochloride and is designed to decrease the potential for abuse."
Mori J. Krantz, MD; Philip S. Mehler, MD, "Treating Opioid Dependence: Growing Implications for Primary Care," Archives of Internal Medicine, (Chicago, IL: American Medical Association, February 2004), Vol. 164, p. 281.
57. Buprenorphine for Maintenance or Detox
"Buprenorphine can be used for either longterm maintenance or for medically supervised withdrawal (detoxification) from opioids. The preponderance of research evidence and clinical experience, however, indicates that opioid maintenance treatments have a much higher likelihood of long-term success than do any forms of withdrawal treatment. In any event, the immediate goals in starting buprenorphine should be stabilization of the patient and abstinence from illicit opioids, rather than any arbitrary or predetermined schedule of withdrawal from the prescribed medication."
Center for Substance Abuse Treatment, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, Treatment Improvement Protocol (TIP) Series 40, DHHS Publication No. (SMA) 04-3939 (Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004), p. 20.
58. Effectiveness of Buprenorphine Treatment
"A number of clinical trials have established the effectiveness of buprenorphine for the maintenance treatment of opioid addiction. These have included studies that compared buprenorphine to placebo (Johnson et al. 1995; Ling et al. 1998; Fudala et al. 2003), as well as comparisons to methadone (e.g., Johnson et al. 1992; Ling et al. 1996; Pani et al. 2000; Petitjean et al. 2001; Schottenfeld et al. 1997; Strain et al. 1994a, 1994b) and to methadone and levo-alpha-acetyl-methadol (LAAM) (Johnson et al. 2000). Results from these studies suggest that buprenorphine in a dose range of 816 mg a day sublingually is as clinically effective as approximately 60 mg a day of oral methadone, although it is unlikely to be as effective as full therapeutic doses of methadone (e.g., 120 mg per day) in patients requiring higher levels of full agonist activity for effective treatment.
"A meta-analysis comparing buprenorphine to methadone (Barnett et al. 2001) concluded that buprenorphine was more effective than 2035 mg of methadone but did not have as robust an effect as 5080 mg methadone -- much the same effects as the individual studies have concluded."
Center for Substance Abuse Treatment, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction, Treatment Improvement Protocol (TIP) Series 40, DHHS Publication No. (SMA) 04-3939 (Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004), pp. 20-21.
59. Effectiveness of Buprenorphine and Buprenorphine/Naloxone
"Buprenorphine and naloxone in combination and buprenorphine alone are safe and reduce the use of opiates and the craving for opiates among opiate-addicted persons who receive these medications in an office-based setting."
Fudala, Paul J., PhD, T. Peter Bridge, MD, Susan Herbert, MA, William O. Williford, PhD, C. Nora Chiang, PhD, Karen Jones, MS, Joseph Collins, ScD, Dennis Raisch, PhD, Paul Casadonte, MD, R. Jeffrey Goldsmith, MD, Walter Ling, MD, Usha Malkerneker, MD, Laura McNicholas, MD, PhD, John Renner, MD, Susan Stine, MD, PhD, & Donald Tusel, MD for the Buprenorphine/Naloxone Collaborative Study Group, "Office-Based Treatment of Opiate Addiction with a Sublingual-Tablet Formulation of Buprenorphine and Naloxone," New England Journal of Medicine, Sept. 4, 2003, Vol. 349, No. 10, p. 949.
60. Effectiveness of Buprenorphine Treatment
The Danish National Board of Health reported in 2000 that "The Buprenorphine project was initiated in the City of Copenhagen during the autumn of 1998 and was evaluated this year. In conclusion the report points out that this type of substitution therapy is suitable for clients who have not previously been subjected to methadone treatment and which are resourceful. Furthermore, the report concluded that buprenorphine treatment may contribute by a significant percentage to the drug addict becoming drug-free and being able to revert to normal life through work, activation and education rather than any other kind of therapy.20"
Report to the European Monitoring Center on Drugs and Drug Addiction by the Reitox National Focal Point of Denmark, Sundhedsstyrelsen (National Board of Health), "Denmark Drug Situation 2000: National Report on the State of the Drugs Problem in Denmark" (Denmark: National Board of Health and EMCDDA, December 2000), p. 73, citing Leif Skauge, "Erfaringer med implementering af buprenorphinbehandling ved Kobenhavns Kommune," handout at the Drugs Council's research conference in March 2000.