Opiate Treatment with Agonists Including Methadone, Buprenorphine, and Suboxone

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61. Regulation and Certification of Opioid Treatment Programs (OTPs)

Laws and Policies

"Methadone, in use since 1964 for the treatment of opioid dependence, may be dispensed only in federally approved Opioid Treatment Programs (OTPs). Treatment protocols require that a client take the medication at the clinic where it is dispensed daily.4 Take-home dosages are allowed only for clients who have been on an established maintenance program for an extended period of time.
"In October 2002, buprenorphine was approved by the Food and Drug Administration (FDA) for the treatment of opioid dependence. Physicians who obtain specialized training may prescribe buprenorphine. Some of these physicians are in private, office-based practices; others are affiliated with substance abuse treatment facilities or programs and may prescribe buprenorphine to clients at those facilities. Additionally, OTPs may also prescribe and/or dispense buprenorphine."

Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. (April 23, 2013). The N-SSATS Report: Trends in the Use of Methadone and Buprenorphine at Substance Abuse Treatment Facilities: 2003 to 2011. Rockville, MD, p. 1.

62. NIH Expert Panel Conclusions Regarding Methadone Treatment

In November 1997, the National Institutes of Health (NIH) convened a Consensus Panel on Effective Medical Treatment of Heroin Addiction. The panel of national experts concluded:
"• Vigorous and effective leadership is needed within the Office of National Drug Control Policy (ONDCP) (and related Federal and State agencies) to inform the public that dependence is a medical disorder that can be effectively treated with significant benefits for the patient and society.
"• Society must make a commitment to offering effective treatment for opiate dependence to all who need it.
"• The panel calls attention to the need for opiate-dependent persons under legal supervision to have access to MMT [methadone maintenance treatment]. The ONDCP and the U.S. Department of Justice should implement this recommendation.
"• The panel recommends improved training of physicians and other health care professionals in diagnosis and treatment of opiate dependence. For example, we encourage the National Institute on Drug Abuse and other agencies to provide funds to improve training for diagnosis and treatment of opiate dependence in medical schools.
"• The panel recommends that unnecessary regulation of MMT and all long-acting agonist treatment programs be reduced.
"• Funding for MMT should be increased.
"• We advocate MMT as a benefit in public and private insurance programs, with parity of coverage for all medical and mental disorders.
"• We recommend targeting opiate-dependent pregnant women for MMT.
"• MMT must be culturally sensitive to enhance a favorable outcome for participating African American and Hispanic persons.
"• Patients, underrepresented minorities, and consumers should be included in bodies charged with policy development guiding opiate dependence treatment.
"• We recommend expanding the availability of opiate agonist treatment in those States and programs where this treatment option is currently unavailable."

"Effective Medical Treatment of Opiate Addiction," NIH Consensus Statement 1997, Nov 17-19 (Washington, DC: National Institutes of Health), 15(6), p. 24.

63. Efforts Needed to Overcome Opposition to Opioid Agonist Treatment

"The wide international variation in the availability of opioid agonist treatment for opioid-dependent injection drug users, despite documented scientific evidence in support of its efficacy, highlights the impact of political and philosophical forces that determine the availability of this treatment. Few proven therapies for medical conditions are restricted in this fashion. Therefore, efforts to address the political and philosophical opposition to opioid agonist treatment are needed to meet the global needs to prevent HIV transmission."

Sullivan, Lynn, David S. Metzger, Paul J. Fudala & David A. Fiellin, "Decreasing International HIV Transmission: The Role of Expanding Access to Opioid Agonist Therapies for Injection Drug Users," Addiction, February 2005, Vol. 100, No. 2, p. 153.

64. Barry McCaffrey on Methadone

"Science-based methadone maintenance treatment [MMT] helps those addicted to opiates sustain their recovery. The result is less crime, fewer emergency room admissions, more citizens working, and less suffering for families and the community. More individuals contribute in taxes instead of costing in health or imprisonment."

McCaffrey, Barry, "Methadone Saves Lives, Restores Productivity: Drug's Bad Press Shouldn't Harm Treatment for Addiction," (Sunday Globe-Mail: Charleston, WV) January 28, 2007.

65. Marginalization and Stigmatization of Addiction Contribute to Undertreatment

"The marginalization of medical care for opioid dependence and the stigma attached to this diagnosis and methadone maintenance treatment play an important role in untreated opioid dependence. Current federal regulations restrict the care of opioid-dependent patients to federally licensed narcotic treatment programs (NTPs) with little to no involvement by community-based physicians. Recent calls from federal and scientific bodies, including the Institute of Medicine, a National Institutes of Health consensus panel, and the Office of National Drug Control Policy, have recommended restructuring the regulatory processes involved in the treatment of opioid-dependent patients, including increased involvement of primary care physicians."

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.

66. Sustained Release Naltrexone Implants

"In order to overcome the issues of poor t­reatment adherence with oral naltrexone, a number of sustained-release implants have been developed internationally for use in alcohol and opioid dependence. A non-randomized retrospective review examined two types of sustained-release naltrexone implants, oral naltrexone, and historical controls revealed a significant difference between immediate and sustained-­release injectable naltrexone in individuals opioid-free 12 months after initiating treatment. Rates combined for the two types of naltrexone implants were 82% opioid free at 12 months compared to 58% opioid free for the oral naltrexone group, and 52% for the historical control group.32"

Kjome, Kimberly L. and Moeller, F. Gerard, "Long-Acting Injectable Naltrexone for the Management of Patients with Opioid Dependence," Substance Abuse: Research and Treatment 2011:5 1–9, doi: 10.4137/SART.S5452

67. Efficacy of Long-Acting Injectable Naltrexone

"A randomized, double-blind, placebo-controlled trial examined the treatment efficacy of long-acting injectable naltrexone (Naltrel, DrugAbuse Sciences) for relapse prevention in 60 heroin-dependent i­ndividuals. Patients were stratified by sex and years of heroin use and randomized to receive placebo, 192 mg, or 384 mg of long-acting naltrexone intramuscular injections dosed on weeks 1 and 5. In addition to ­medication, patients received relapse prevention therapy and had urine monitored for drug relapse. At the end of 2 months, 39%, 60% and 68% of the placebo, 192 mg naltrexone and 384 mg naltrexone groups, respectively were still in treatment. Mean treatment drop-out occurred in 27 days, 36 days, and 48 days for the placebo, 192 mg naltrexone and 384 mg naltrexone groups. Assuming that missing urine samples were positive, patients receiving placebo had the lowest mean percentage of negative urine samples (25.3%), with the highest mean percentage of negative urine samples in the patient group receiving 384 mg of naltrexone (61.9%). There was a significant main effect of group (P = 0.03), but without assumption of missing urines being positive, was no longer ­significant. This study highlighted the issues of treatment retention with long-acting injectable naltrexone, but was limited by small sample size, and direct comparison to treatment retention with oral naltrexone.40"

Kjome, Kimberly L. and Moeller, F. Gerard, "Long-Acting Injectable Naltrexone for the Management of Patients with Opioid Dependence," Substance Abuse: Research and Treatment 2011:5 1–9, doi: 10.4137/SART.S5452

68. Pain Patients in Methadone Treatment

"Pain was very prevalent in representative samples of 2 distinct populations with chemical dependency, and chronic severe pain was experienced by a substantial minority of both groups. Methadone patients differed from patients recently admitted to a residential treatment center in numerous ways and had a significantly higher prevalence of chronic pain (37% vs. 24%). Although comparisons with other studies of pain epidemiology are difficult to make because of methodological differences, the prevalence of chronic pain in these samples is in the upper range reported in surveys of the general population. The prevalence of chronic pain in these chemically dependent patients also compares with that in surveys of cancer patients undergoing active therapy, approximately a third of whom have pain severe enough to warrant opioid therapy."

Rosenblum, Andrew, PhD, Herman Joseph, PhD, Chunki Fong, MS, Steven Kipnis, MD, Charles Cleland, PhD, Russell K. Portenoy, MD, "Prevalence and Characteristics of Chronic Pain Among Chemically Dependent Patients in Methadone Maintenance and Residential Treatment Facilities," Journal of the American Medical Association (Chicago, IL: American Medical Association, May 14, 2003), Vol. 289, No. 18, p. 2376.

69. Levomethadyl (LAAM) No Longer Available For Clinical Use

"LAAM (levo-alpha-acetylmethadol) is no longer approved for use in Europe and is not available for clinical use in the United States. In Europe, reports of several cases of ventricular tachycardia (torsade de pointes: TdP) occurring in patients treated with LAAM led the European Medicines Evaluation Agency (EMEA) to suspend authorization for its marketing in 2001. In the same year, responding to the reports of LAAM-related cases of TdP, the United States Food and Drug Administration (FDA) required the addition of a ‘black box’ warning on the LAAM label. The label states that LAAM should be used only for patients who failed treatment with other agents and that all patients receiving LAAM should have baseline electrocardiogram (ECG) screening and periodic monitoring [1]. Because most clinics were reluctant to initiate such ECG assessments, the use of LAAM (not very high to begin with), dropped sharply. In 2003, Roxane Laboratories, the sole distributor of LAAM, announced its decision to discontinue its sale. However, it remains an FDA-approved therapeutic agent."

Jaffe, Jerome, "Can LAAM, Like Lazarus, Come Back From the Dead" (Editorial), Addiction, Aug 9, 2007, Vol. 102, No. 9, p. 1342, doi:10.1111/j.1360-0443.2007.01976.x

70. Levomethadyl Compared with Methadone

"It is now clear that methadone as well as LAAM can prolong the QT interval, and that instances of TdP have been reported with both agents. Screening to identify patients at risk for unacceptable degrees of QT prolongation ought to be a part of agonist treatment with any agent known to be a torsadogen. With proper screening and ECG monitoring it seems likely that arrhythmias associated with agonist therapy can be reduced substantially or prevented. Once such screening becomes routine there may be an opportunity in the United States, where LAAM is still approved, to persuade a pharmaceutical company or the government to make it available again. Many clinicians believe that LAAM adds an important therapeutic option. Perhaps even the EMEA would reconsider its decision to withdraw its approval of LAAM."

Jaffe, Jerome, "Can LAAM, Like Lazarus, Come Back From the Dead" (Editorial), Addiction, Aug 9, 2007, Vol. 102, No. 9, p. 1343, doi:10.1111/j.1360-0443.2007.01976.x