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1.
Drug Alcohol Depend ; 57(1): 7-22, 1999 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-10617309

RESUMEN

Tramadol HCl, marketed as Ultram in the USA, was introduced as a non-scheduled drug in April 1995 based on the assumption that the risk of abuse was sufficiently low to warrant a non-scheduled status. However, approval was contingent upon the development of an innovative proactive surveillance program, to be overseen by an independent steering committee, which would detect unexpectedly high levels of abuse. The postmarketing surveillance program consisted of systematic collection and scientific evaluation of reports of suspected abuse in high-risk populations surveyed through an extensive key informant network of drug abuse specialists and all spontaneous reports of abuse received through the FDA MedWatch system. Methods to estimate the number of patients prescribed tramadol were also developed. Monthly rates of abuse were calculated as an index of the risk-benefit ratio (i.e., abuse cases per 100,000 patients prescribed the drug). The data for the 3 years since the drug was introduced show that the reported rate of abuse has been low. Although a period of experimentation seemed to occur in the first 18 months after its introduction--which reached a peak rate of approximately two cases per 100,000 patients exposed--during the 2 year period prior to June 1998, the reported rate of abuse has significantly (P = 0.011) declined, reaching levels of less than one case per 100,000 patients in the last 18 months. The overwhelming majority of abuse cases (97%) have been found to occur among individuals with a history of substance abuse and the abuse has been confined to isolated pockets around the country-notably none of which have significant populations of street drug abusers. Thus, the data support the decision not to schedule tramadol and, furthermore, suggest that a proactive post-marketing surveillance program can be successfully developed to effectively monitor abuse of new medications.


Asunto(s)
Analgésicos Opioides , Prescripciones de Medicamentos/estadística & datos numéricos , Vigilancia de Productos Comercializados/estadística & datos numéricos , Trastornos Relacionados con Sustancias/epidemiología , Tramadol , Humanos , Medición de Riesgo/estadística & datos numéricos , Trastornos Relacionados con Sustancias/prevención & control , Estados Unidos/epidemiología
2.
J Psychoactive Drugs ; 27(1): 39-47, 1995.
Artículo en Inglés | MEDLINE | ID: mdl-7602439

RESUMEN

This article describes a 300-bed substance abuse treatment program that is part of a continuum of care focused on preventing drug and criminal recidivism in substance abusing criminals incarcerated in Dallas County, Texas. It is the product of a joint effort of the judiciary, the Dallas County Supervision and Corrections Department, the State of Texas Criminal Justice Division, and Interventions Co., a not-for-profit treatment provider. The program is rooted in over 25 years of treatment experience and incorporates therapeutic community (TC) technology combined with 12-Step programming, behavior modification, job training (having a job is required for graduation), educational, and medical/psychiatric elements. Treatment is conceived as part of a continuum of care to provide substantial and sustained support for the inmate in the difficult process of adapting to the community post incarceration. Treatment plans are individualized and are based on an extended workup in which the individual's status in a number of domains is assessed. Specialized services, such as transportation and childcare, facilitate recovery. Once in the community, urine monitoring, groups, and counseling continue. The program is beginning its fourth year of operation and approximately 600 inmates have started the program. A formal evaluation is in process.


Asunto(s)
Tratamiento Domiciliario , Trastornos Relacionados con Sustancias/rehabilitación , Adulto , Crimen , Etnicidad , Familia , Femenino , Humanos , Masculino , Recurrencia , Apoyo Social , Trastornos Relacionados con Sustancias/psicología , Texas , Comunidad Terapéutica
3.
J Addict Dis ; 13(3): 65-9, 1994.
Artículo en Inglés | MEDLINE | ID: mdl-7734460

RESUMEN

In a pilot study, 130 methadone maintained subjects with a six-month history of good treatment performance were assigned randomly, for a one-year study period, to an experimental condition (once per month non-random urine screen, counseling session and doctor visit, two times per month methadone pick up, a quarterly true random urine screen, and participation in a diversion control program), or they were assigned to a control condition of staying under standard conditions for six months and then being transferred to the experimental condition for six months. Three out of four subjects (73%) completed the year in good standing with no differences between control and experimental conditions. Subject satisfaction was such that the Institutional Review Board judged that return to standard conditions would be a hardship. A Study of Medical Maintenance (SMM) continues and extends the pilot study with two protocols: (1) for new subjects and (2) for subjects entered from the pilot study. SMM requires a once per month random urine screen and extends the experimental condition to two years but is otherwise identical to the pilot study; 71 of 107 S's (66%) entered protocol 1 and are in good standing. Pilot subjects (N = 75) are holding their good performance, some for over four years. The reduced levels of services in these studies free up resources which can be applied to entering IDU's into treatment thereby contributing to a slowing of the HIV epidemic.


Asunto(s)
Metadona/uso terapéutico , Trastornos Relacionados con Opioides/rehabilitación , Grupo de Atención al Paciente , Abuso de Sustancias por Vía Intravenosa/rehabilitación , Adulto , Terapia Conductista , Terapia Combinada , Consejo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Trastornos Relacionados con Opioides/psicología , Cooperación del Paciente/psicología , Proyectos Piloto , Rehabilitación Vocacional/psicología , Detección de Abuso de Sustancias , Abuso de Sustancias por Vía Intravenosa/psicología , Resultado del Tratamiento
4.
J Addict Dis ; 12(4): 59-76, 1993.
Artículo en Inglés | MEDLINE | ID: mdl-8292640

RESUMEN

In a one year study, 130 methadone maintained subjects with a six month history of good treatment performance were assigned randomly to an experimental condition of one monthly non-random urine screen, one monthly counseling session, one monthly doctor visit, two times per month methadone pick up, a quarterly true random urine screen and participation in a diversion control program or to a control condition of staying under standard conditions for six months and then being transferred to the experimental condition for six months. Results of urine screens and scores on the Addiction Severity Index (ASI) at entrance and six month intervals showed no differences between groups. Three out of four subjects completed the year in good standing. Subject satisfaction was such that the IRB judged that return to standard conditions would be a hardship. Experimental conditions were cheaper such that resources freed up could be applied to the HIV epidemic.


Asunto(s)
Metadona/uso terapéutico , Trastornos Relacionados con Sustancias/tratamiento farmacológico , Adulto , Femenino , Seropositividad para VIH/complicaciones , Seropositividad para VIH/diagnóstico , Humanos , Masculino , Metadona/administración & dosificación , Metadona/orina , Persona de Mediana Edad , Proyectos Piloto , Índice de Severidad de la Enfermedad , Trastornos Relacionados con Sustancias/complicaciones , Trastornos Relacionados con Sustancias/prevención & control , Resultado del Tratamiento
5.
Drug Saf ; 6 Suppl 1: 1-65, 1991.
Artículo en Inglés | MEDLINE | ID: mdl-2021427

RESUMEN

During the past 20 years there has been a substantial increase in the data available on the prevalence and consequences of the use of drugs which are liable to abuse. The body of data is sufficiently scientific, comprehensive and global in scope to enable an overall profile of the use patterns of these drugs to be drawn in this review. The studies evaluated include those which surveyed populations of hundreds, thousands, or even more, covering a range of common drugs of abuse and using specified research methods. The data are summarised for North America, Europe, Asia and the West Pacific, Africa and South America. A complex picture has emerged, confounded by an array of factors, which this review does not address in detail, such as youth alienation, the changing role of women and the increasing sophistication of criminal networks. From a global perspective, the evidence reviewed from the various regions indicates that the use of drugs with liability for abuse is widespread and associated with public health and social problems of great magnitude. The major set of problems appears to be related to primary pattern drugs such as alcohol, nicotine, cannabis and the opioids. Cocaine may also be a worldwide threat in view of the problems it has created in some regions. Drug abuse usually starts in adolescence, and both sexes now appear to be involved where in the recent past it was predominantly men who were affected. The concurrent use of multiple substances is now becoming the modal pattern, and drug-related problems correlate with one another and with somatic, psychiatric and social pathology. Opioid use now tends to be via intravenous administration, and the doses of cannabis and cocaine base which are used are increasing. Substances with therapeutic effects on DSM-III-R diagnosable disorders, such as antidepressants and benzodiazepines, require careful consideration by policymakers because the risk:benefit ratio is different to that of primary-pattern intoxicants, especially taking into consideration the broad and proven therapeutic use of these substances and the need for their availability for patients and physicians. In conclusion, the data presented in this review indicate that the scientific description of trends and consequences of drug abuse is an indispensable first step in rational policy making. The review also identifies areas for further study and research.


Asunto(s)
Salud Global , Salud Pública , Trastornos Relacionados con Sustancias/epidemiología , África/epidemiología , Asia/epidemiología , Europa (Continente)/epidemiología , Política de Salud , Humanos , América del Norte/epidemiología , América del Sur/epidemiología , Trastornos Relacionados con Sustancias/complicaciones
6.
Adv Alcohol Subst Abuse ; 9(3-4): 53-64, 1990.
Artículo en Inglés | MEDLINE | ID: mdl-1981124

RESUMEN

This paper examines data on the question of possible differences between benzodiazepines in abuse liability and potential for causing physical dependence. The data on potential for causing physical dependence indicates that all benzodiazepines cause physical dependence and there is little evidence for substantial differences between them in this respect. The evidence for substantive differences between benzodiazepines with respect to abuse liability is reviewed: problems with methodology and with definitions make problematic the assertion of some authors that there are clinically meaningful differences in abuse liability. There is general agreement that all benzodiazepines have at least some abuse liability.


Asunto(s)
Ansiolíticos , Trastornos Relacionados con Sustancias/etiología , Nivel de Alerta/efectos de los fármacos , Benzodiazepinas , Relación Dosis-Respuesta a Droga , Humanos , Factores de Riesgo
9.
Adv Alcohol Subst Abuse ; 8(1): 107-24, 1989.
Artículo en Inglés | MEDLINE | ID: mdl-2565664

RESUMEN

A review of scientific and clinical evidence indicates: (1) benzodiazepines have an abuse liability and can cause physical dependence, (2) abuse liability is of a lower order of magnitude than that associated with common intoxicants such as barbiturates, opioids or stimulants, (3) sustained, exclusive use of benzodiazepines for inducing intoxication occurs but, it is infrequent, (4) benzodiazepines tend to be secondary drugs to a preferred primary intoxicant; in experimental paradigms normals prefer placebo to benzodiazepines, (5) susceptibility to physical dependence varies widely as low doses are sufficient to produce it in some but very high multiples are not sufficient to produce it in many others, (6) factors predisposing to physical dependence are: total lifetime dose, previous exposure to drugs cross-tolerant, such as alcohol or barbiturates, concomitant severe medical/psychiatric problems, and severe persisting stress. Individual susceptibility to abuse and to become dependent on benzodiazepines should be investigated much more vigorously than it has heretofore.


Asunto(s)
Ansiolíticos , Trastornos Relacionados con Sustancias/etiología , Adulto , Ansiolíticos/efectos adversos , Benzodiazepinas , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Persona de Mediana Edad , Factores de Riesgo , Síndrome de Abstinencia a Sustancias/etiología
11.
Cancer ; 63(2): 360-3, 1989 Jan 15.
Artículo en Inglés | MEDLINE | ID: mdl-2910443

RESUMEN

An 86-year-old woman who developed small bowel adenocarcinoma 40 years following in-continuity bypass of a 60-cm segment of regional ileitis represents the 22nd reported patient with this complication of bypassed Crohn's disease. Her case demonstrates several of the typical clinical features of such cancers: late recrudescence of disease following a 40-year period of relative quiescence; delayed diagnosis due to misinterpretation of the clinical picture (intestinal obstruction, abdominal mass, intraabdominal abscess, and fistula formation) as due to inflammatory bowel disease; and an exceedingly poor prognosis with rapid widespread local dissemination and death. Histologically, severe dysplasia was demonstrated both in close proximity to and at a distance from the lesion. The increasing number of case reports of adenocarcinoma arising at the site of long-standing Crohn's disease, many with dysplasia within areas of diseased bowel, is further evidence that Crohn's disease is a precancerous condition. Physicians must continue to search for methods of earlier diagnosis to improve the prognosis of small bowel carcinoma in Crohn's disease.


Asunto(s)
Adenocarcinoma/etiología , Enfermedad de Crohn/complicaciones , Neoplasias del Íleon/etiología , Adenocarcinoma/patología , Adenocarcinoma/secundario , Anciano , Anciano de 80 o más Años , Colostomía/efectos adversos , Enfermedad de Crohn/cirugía , Femenino , Humanos , Neoplasias del Íleon/patología , Neoplasias Hepáticas/secundario , Factores de Riesgo
15.
Int J Addict ; 20(6-7): 803-21, 1985.
Artículo en Inglés | MEDLINE | ID: mdl-3908338

RESUMEN

This paper reviews the world literature on methadone. Methadone has been used in hundreds of thousands of patients, in disparate social, economic, cultural, and geographic situations; it has been evaluated in scores of studies. The large majority of evaluations demonstrate that opioid use, criminality, and general health status are affected positively in many addicts. Smaller gains in job and family functions are noted. Alcoholism and multiple drug use complicate treatment for some addicts. Despite the positive data, public opinion remains negative about this treatment. The use of methadone in withdrawal from opioid dependence and in pregnancy complicated by opioid dependence is discussed.


Asunto(s)
Metadona/uso terapéutico , Trastornos Relacionados con Opioides/rehabilitación , Alcoholismo/complicaciones , Antidepresivos/uso terapéutico , Ensayos Clínicos como Asunto , Glándulas Endocrinas/efectos de los fármacos , Femenino , Humanos , Trastornos Mentales/complicaciones , Metadona/efectos adversos , Metadona/farmacología , Acetato de Metadil/uso terapéutico , Trastornos Relacionados con Opioides/complicaciones , Trastornos Relacionados con Opioides/terapia , Pacientes Desistentes del Tratamiento , Embarazo , Complicaciones del Embarazo , Síndrome de Abstinencia a Sustancias/tratamiento farmacológico , Comunidad Terapéutica , Factores de Tiempo , Estados Unidos
16.
Drug Alcohol Depend ; 14(3-4): 305-12, 1985 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-3996213

RESUMEN

'T's and B's' started to become widely used in Chicago in the early 1970s. Users reported an interaction between the two drugs which was expressed in slang terms such as 'Toms and Bettys', 'T'shirts and Blue Jeans.' By the late 1970s, T's and B's users occupied 10% of the treatment census in Chicago. Soft tissue damage was more pronounced with 'T's and B's' than with heroin and a number of serious medical complications were observed, e.g. pulmonary hypertension. The introduction of Talwin NX appears to have decreased greatly the use of T's and B's as demand for treatment for primary abuse of this combination is close to zero in 1983-84.


Asunto(s)
Pentazocina , Trastornos Relacionados con Sustancias/complicaciones , Tripelenamina , Adulto , Infecciones Bacterianas/etiología , Chicago , Cicatriz/etiología , Interacciones Farmacológicas , Femenino , Humanos , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Pentazocina/farmacología , Embarazo , Tripelenamina/farmacología
17.
Arch Gen Psychiatry ; 41(2): 193-9, 1984 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-6365017

RESUMEN

Various schedules exist for inducting heroin addicts newly admitted to treatment into methadyl acetate maintenance and crossover schedules for the transition from methadone maintenance to methadyl acetate maintenance. A sample of 255 street addicts was randomized to three induction schedules: methadyl acetate three times a week (tiw) with placebos on alternate days; methadyl acetate tiw supplemented with decreasing doses of methadone on alternate days; methadyl acetate six days a week with diminishing doses on three days. Treatment was double-blind for four weeks and single-blind for six. All schedules were considered feasible, but supplementation with methadyl acetate or methadone had no advantage. A sample of 310 patients receiving methadone maintenance was randomized to comparable supplementation groups, except that the group receiving supplementary methadyl acetate received it along with the regular dose. This schedule was not successful. Supplementing with methadone had no advantage.


Asunto(s)
Dependencia de Heroína/rehabilitación , Metadona/análogos & derivados , Metadona/administración & dosificación , Acetato de Metadil/administración & dosificación , Adolescente , Adulto , Actitud Frente a la Salud , Ensayos Clínicos como Asunto , Método Doble Ciego , Esquema de Medicación , Quimioterapia Combinada , Dependencia de Heroína/psicología , Humanos , Masculino , Pacientes Desistentes del Tratamiento , Placebos , Distribución Aleatoria , Síndrome de Abstinencia a Sustancias/prevención & control
19.
Am J Drug Alcohol Abuse ; 10(3): 361-74, 1984.
Artículo en Inglés | MEDLINE | ID: mdl-6528870

RESUMEN

We studied 108 heroin-dependent patients who had been "stabilized" on methadone, i.e., had no change in methadone dose for at least 2 weeks. With respect to their methadone detoxification regimen, 65 of the study patients preferred physician regulation and 43 study patients preferred self-regulation. Half of each group was randomly assigned to self- or physician regulation. Twenty-five of the 108 patients reached abstinence following a regimen which lasted 22 weeks; there was no statistically significant difference in proportion of subjects reaching abstinence from any of the four study groups. We observed no differences in treatment retention, symptom severity, frequency of urines positive for morphine or quinine, or psychosocial functioning. Study subjects preferring self-regulation had statistically significant increases in the number of dose raises. We conclude that there is no evidence to support the belief that physician regulation is superior to self-regulation in opioid detoxification regimens.


Asunto(s)
Dependencia de Heroína/rehabilitación , Metadona/administración & dosificación , Adolescente , Adulto , Femenino , Dependencia de Heroína/psicología , Humanos , Masculino , Pacientes Desistentes del Tratamiento , Distribución Aleatoria , Autoadministración
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