Changing the Treatment Direction for Opiate Addiction: Dr. Dole's Research.

Under the leadership of Drs. Vincent P. Dole, Marie Nyswander, and Mary Jeanne Kreek, in collaboration with the psychologist, Norman Gordon and sociologist, Herman Joseph at The Rockefeller University beginning in the 1960s, the first medical treatment for heroin addiction was developed. Drs. Dole, Nyswander and Kreek also developed the first hypothesis of opiate addiction as a metabolic disease. This biological revolution challenged beliefs about addiction, spurred further research and challenged legal positions of the judiciary and the broader criminal justice system (Dole & Nyswander, 1967 ).

Medication-Assisted Treatment (MAT) for Opioid Addiction: Introduction to the Special Issue.

Several countries are experiencing public health crises as a result of opioid addiction. Fatal overdoses have reached record highs in many regions and Hepatitis C virus is the norm among people who inject drugs in several countries. Thus, providing for the global availability of medication-assisted treatment (MAT) for opioid addiction is more important than ever. In this article, we introduce readers to the collection of papers that appear in this special issue on MAT for opioid addiction. We describe the articles and commentaries thematically to include topics that address 1) the contemporary history of methadone maintenance, 2) the provision of and access and barriers to MAT, 3) compliance and outcomes of MAT, 4) health issues among MAT patients, 5) race, ethnicity, and social class backgrounds of MAT patients, 6) criminalization and stigma, and 7) challenges associated with the expansion of MAT.

From Narcotic to Normalizer: The Misperception of Methadone Treatment and the Persistence of Prejudice and Bias.

This article concentrates on methadone maintenance as a normalizer for the impairments of opioid addiction, and the misunderstandings of it as a substitute for heroin that continues an opiate addiction. Methadone treatment was developed by Drs. Dole, Nyswander, and Kreek. Their cutting-edge theory transformed the way that opioid addiction is perceived and their work changed methadone from a narcotic to withdraw addicts to a medication that is a maintenance normalizer for a chronic condition. Their extensive research involved the physiological and sociological normalizing effects of methadone and medical safety of the medication (Dole & Nyswander, 1967).

Prevalence and characteristics of chronic pain in patients admitted to an outpatient drug and alcohol treatment program.

OBJECTIVES: To evaluate the prevalence, characteristics, and correlates of chronic pain in a population of predominantly employed, alcoholic patients attending an outpatient drug and alcohol treatment program. METHODS: A pain survey was administered to 79 patients attending an outpatient drug and alcohol treatment program situated in a suburban community outside of New York City. Chronic severe pain was defined as pain that 1) had persisted for at least 6 months; and 2) was either moderate to severe in intensity or significantly interfered with daily activities. RESULTS: Seventy-six percent of patients experienced pain during the past week. Chronic severe pain was experienced by 29.1% of patients. High levels of pain interference with physical and psychosocial functioning were reported by 26.1%. Patients with chronic severe pain were more likely to have significant comorbidity, to cite physical pain as the impetus for alcohol or drug abuse, to have abused a prescription drug or used an illicit drug to treat pain during the prior 3 months, and to have used illicitly obtained opioids. Only 13% of patients with chronic severe pain were currently receiving pain treatment and 72% expressed interest in receiving treatment. DISCUSSION: Chronic severe pain was prevalent in this predominantly employed, alcoholic population attending an outpatient drug and alcohol treatment program. Pain was associated with significant functional impairment, medical and psychiatric comorbidities, and abuse behaviors. Few patients accessed adequate pain treatment. Efforts should be made to better address the pain problems in this patient population.

Opioids and the treatment of chronic pain: controversies, current status, and future directions.

Opioids have been regarded for millennia as among the most effective drugs for the treatment of pain. Their use in the management of acute severe pain and chronic pain related to advanced medical illness is considered the standard of care in most of the world. In contrast, the long-term administration of an opioid for the treatment of chronic noncancer pain continues to be controversial. Concerns related to effectiveness, safety, and abuse liability have evolved over decades, sometimes driving a more restrictive perspective and sometimes leading to a greater willingness to endorse this treatment. The past several decades in the United States have been characterized by attitudes that have shifted repeatedly in response to clinical and epidemiological observations, and events in the legal and regulatory communities. The interface between the legitimate medical use of opioids to provide analgesia and the phenomena associated with abuse and addiction continues to challenge the clinical community, leading to uncertainty about the appropriate role of these drugs in the treatment of pain. This narrative review briefly describes the neurobiology of opioids and then focuses on the complex issues at this interface between analgesia and abuse, including terminology, clinical challenges, and the potential for new agents, such as buprenorphine, to influence practice.

Outcomes of buprenorphine maintenance in office-based practice.

Buprenorphine is an efficacious treatment for opioid dependence recently approved for office-based medical practice. The purpose of the study was to describe the background characteristics, treatment process, outcomes and correlates of outcomes for patients receiving buprenorphine maintenance in "real world" office-based settings in New York City, without employing the many patient exclusion criteria characterizing clinical research studies of buprenorphine, including absence of co-occurring psychiatric and non-opioid substance use disorders. A convenience sample of six physicians completed anonymous chart abstraction forms for all patients who began buprenorphine induction or who transferred to these practices during 2003-2005 (N = 86). The endpoint was the patient's current status or status at discharge from the index practice, presented in an intent-to-treat analysis. The results were: male (74%); median age (38 yrs); White, non-Hispanic (82%); employed full-time, (58%); HCV+ (15%); substance use at intake: prescription opioids (50%), heroin (35%), non-opioids (49%); median length of treatment (8 months); median maintenance dose (15 mg/day); prescribed psychiatric medication (63%). The most frequent psychiatric disorders were: major depression, obsessive-compulsive and other anxiety, bipolar. At the endpoint: retained in the index practice (55%); transferred to other buprenorphine practice (6%); transferred to other treatment (7%); lost to contact or out of any treatment (32%). Outcomes were positive, in that 2/3 of patients remained in the index practice or transferred to other treatment. Patients living in their own home or misusing prescription opioids (rather than heroin) were more likely, and those employed part-time were less likely, to be retained in the index practice. At the endpoint, 24% of patients were misusing drugs or alcohol. Co-occurring psychiatric disorders and polysubstance abuse at intake were common, but received clinical attention, which may explain why their effect on outcomes was minimal.

A 5-year evaluation of a methadone medical maintenance program.

Methadone medical maintenance (MMM) is a model for the treatment of opioid dependence in which a monthly supply of methadone is distributed in an office setting, in contrast to more highly regulated settings where daily observed dosing is the norm. We assessed patient characteristics and treatment outcomes of an MMM program initiated in the Bronx, New York, in 1999 by conducting a retrospective chart review. Participant characteristics were compared with those of patients enrolled in affiliated conventional methadone maintenance treatment programs. Patients had diverse ethnicities, occupations, educational backgrounds, and income levels. Urine toxicology testing detected illicit opiate and cocaine use in 0.8% and 0.4% of aggregate samples, respectively. The retention rate was 98%, which compares favorably with the four other MMM programs that have been reported in the medical literature. This study demonstrates that selected patients from a socioeconomically disadvantaged population remained clinically stable and engaged in treatment in a far less intensive setting than traditional methadone maintenance.

Stigma from the Viewpoint of the Patient.

Stigma has become a primary social force facing patients in methadone and buprenorphine treatment. For quality methadone and buprenorphine treatment to flourish it will be necessary to confront and reduce this negative influence. This article, co-authored by a patient and professional, discusses stigma and prejudice from the viewpoint of patients. Educational and national strategies using the media and targeted to patients, programs, and the general public are discussed.

Harm Reduction: Front Line Public Health.

Drug use is a public health problem associated with high mortality and morbidity, and is often accompanied by suboptimal engagement in health care. Harm reduction is a pragmatic public health approach encompassing all goals of public health: improving health, social well-being, and quality of life. Harm reduction prioritizes improving the lives of people who use drugs in partnership with those served without a narrow focus on abstinence from drugs. Evidence has shown that harm reduction oriented practice can reduce transmission of blood-borne illnesses, and other injection related infections, as well as preventing fatal overdose.

Methadone Medical Maintenance: An Early 21st-Century Perspective.

Methadone medical maintenance is the treatment of stable methadone-maintained patients in primary care physicians' offices under an exemption from federal methadone regulations. Reports from seven such programs in six states show high retention and low frequencies of illicit drug use. Patients and physicians indicate high levels of satisfaction. Although methadone maintenance has a long history of safety and efficacy, most methadone medical maintenance programs are no longer operating or accepting new patients. Federal regulations for standard methadone clinics allow some features of methadone medical maintenance, and advocacy for state approval of these changes is strongly recommended.

Conducting Rapid Street Assessment of Drug Users in New York City Using Oral Fluid and Brief Interviews: A Feasibility Study.

This study piloted the feasibility of rapidly collecting both self-reports of drug use and saliva specimens for drug toxicology in field settings. The use of oral fluid collection devices to supplement self-reports is unproven in street settings and may pose challenges for field research. Sixty adults who identified as recent illicit drug users were recruited in public settings in New York City and were asked to complete a brief drug screening inventory and provided saliva specimens. Descriptive findings are detailed along with critical best research practices and limitations that provide important directions for researchers looking to employ both toxicology and self-report in rapid field recruitment designs.

The use of levo-alpha-acetylmethadol (LAAM) in methadone patients who have not achieved heroin abstinence.

Levo-alpha-acetylmethadol (LAAM) pharmacotherapy was offered to twelve patients who continued illicit opioid abuse after > or = eleven months in methadone maintenance treatment. After 6-8 weeks on LAAM, plasma concentrations of the norLAAM metabolite varied significantly by LAAM dosing day, plasma adrenocorticotropin (ACTH) concentrations were significantly increased compared to methadone, and two of the seven subjects remaining in LAAM treatment were free of illicit opioids and nonprescribed methadone. After one year, one of five remaining subjects was using illicit opioids, and three were using non-prescribed methadone. While subject acceptance of LAAM was high, subjects were not in a "steady-state," with evidence of ongoing illicit opioid abuse.

Reducing stigma through education to enhance Medication-Assisted Recovery.

The National Alliance for Medication Assisted Recovery has started projects to address the stigma that impacts medication-assisted treatment. The Certified Medication Assisted Treatment Advocate Program trains patients and professionals for advocacy in seminars and conferences. The MARS Project educates (Einstein, Bronx, New York) buprenorphine and methadone patients to dispel stigma and achieve better treatment outcomes. Beyond MARS trains patients nationwide to replicate the MARS Project. Stop Stigma Now will create a national public relations campaign to overcome ignorance and stigma. These projects have the potential to end stigma and elevate medication-assisted treatment to its rightful place as the gold standard of treatment.

Housing First for severely mentally ill homeless methadone patients.

The Housing First approach used by Pathways to Housing, Inc., was used to enhance residential independence and treatment retention of homeless, seriously mentally ill methadone patients. The Keeping Home project first secured scattered-site apartments and assertive community treatment services and then addressed patients' service needs. Three years post-implementation, methadone treatment retention for 31 Keeping Home patients versus 30 comparison participants (drawn from an administrative database) was 51.6% vs. 20% (p < .02); apartment/independent housing retention was 67.7% vs. 3% or 13% (both p's < .01). Although results firmly support Keeping Home, future research needs to address study's possible database limitations.

Opioid maintenance treatment as a harm reduction tool for opioid-dependent individuals in New York City: the need to expand access to buprenorphine/naloxone in marginalized populations.

The aim of this pilot study was to assess the effectiveness of buprenorphine/naloxone (BUP/NX) among marginalized, opioid-dependent individuals in terms of retention in and cycling into and out of a harm-reduction program. This pilot study enrolled 100 participants and followed them from November 2005 to July 2008. The overall proportion of patients retained in the program at the end of 3, 6, 9, and 12 months was 68%, 63%, 56%, and 42%, respectively. This pilot study demonstrated that BUP/NX could be successfully used to treat marginalized heroin users.

Sublingual buprenorphine/naloxone for chronic pain in at-risk patients: development and pilot test of a clinical protocol.

OBJECTIVE: Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated patients with pain with nonadherence behaviors. The transition of opioid-treated patients with pain to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. DESIGN: The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full m-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3-6 months with the expectation that they would experience few adverse events (AEs) and report lower pain severity. RESULTS: The three patients on the highest baseline opioid dose (equivalent to 303-450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early AEs when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a 3-month trial. A mixed-effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < 0.01). CONCLUSION: Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing.

Buprenorphine and methadone maintenance in jail and post-release: a randomized clinical trial.

Buprenorphine has rarely been administered as an opioid agonist maintenance therapy in a correctional setting. This study introduced buprenorphine maintenance in a large urban jail, Rikers Island in New York City. Heroin-dependent men not enrolled in community methadone treatment and sentenced to 10-90 days in jail (N=116) were voluntarily randomly assigned either to buprenorphine or methadone maintenance, the latter being the standard of care for eligible inmates at Rikers. Buprenorphine and methadone maintenance completion rates in jail were equally high, but the buprenorphine group reported for their designated post-release treatment in the community significantly more often than did the methadone group (48% vs. 14%, p<.001). Consistent with this result, prior to release from Rikers, buprenorphine patients stated an intention to continue treatment after release more often than did methadone patients (93% vs. 44%, p<.001). Buprenorphine patients were also less likely than methadone patients to withdraw voluntarily from medication while in jail (3% vs. 16%, p<.05). There were no post-release differences between the buprenorphine and methadone groups in self-reported relapse to illicit opioid use, self-reported re-arrests, self-reported severity of crime or re-incarceration in jail. After initiating opioid agonist treatment in jail, continuing buprenorphine maintenance in the community appears to be more acceptable to offenders than continuing methadone maintenance.

New York City injection drug users' memories of syringe-sharing patterns and changes during the peak of the HIV/AIDS epidemic.

In this oral history, 23 injection drug users (IDUs) were interviewed about the mid-1970s to mid-1980s when they could not legally purchase or possess syringes, and the threat of AIDS began to loom large. Several themes emerged, including: abrupt changes in syringe-sharing patterns; the effects of illnesses or deaths of others on their understanding of AIDS; and, racial/ethnic differences in responses to the threat of AIDS. Settings, such as "shooting galleries," helped HIV spread rapidly in the earliest stages of the city's AIDS epidemic. HIV entered the drug scene in the mid-1970s, just when IDUs were shifting from sharing homemade "works" (consisting of steel needles and syringes devised from rubber baby pacifiers and similar sources) among many IDUs to mass produced and distributed plastic, disposable needle and syringe sets. IDUs remember when they first became aware of AIDS and began to adjust their behaviors and social assumptions.