Monoaminergic system and depression.

Major depressive disorder is a severe, disabling disorder that affects around 4.7% of the population worldwide. Based on the monoaminergic hypothesis of depression, monoamine reuptake inhibitors have been developed as antidepressants and nowadays, they are used widely in clinical practice. However, these drugs have a limited efficacy and a slow onset of therapeutic action. Several strategies have been implemented to overcome these limitations, including switching to other drugs or introducing combined or augmentation therapies. In clinical practice, the most often used augmenting drugs are lithium, triiodothyronine, atypical antipsychotics, buspirone, and pindolol, although some others are in the pipeline. Moreover, multitarget antidepressants have been developed to improve efficacy. Despite the enormous effort exerted to improve these monoaminergic drugs, they still fail to produce a rapid and sustained antidepressant response in a substantial proportion of depressed patients. Recently, new compounds that target other neurotransmission system, such as the glutamatergic system, have become the focus of research into fast-acting antidepressant agents. These promising alternatives could represent a new pharmacological trend in the management of depression.

Medida de la eficiencia técnica de programas de tratamiento con opiáceos: utilidad del modelo Data Envelopment Analysis (DEA) / Measurement of the technical efficiency of opioid substitution programs: Usefulness of the Data Envelopment Analysis (DEA) model

Objetivo. Valorar la utilidad del modelo matemático Data Envelopment Analysis (DEA) para medir la eficiencia de programas de tratamiento con opiáceos (PTO). Material y métodos. Se realiza un estudio de "simulación", es decir, se parte de un conjunto de supuestos y se manejan datos no reales pero fundamentados en la literatura. Se comparan 15 hipotéticos PTO y se mide la eficiencia de cada uno de ellos. De cada programa habríamos obtenido información sobre seis variables, tres de las cuales serían consideradas como indicadores de input (ratio terapeuta/paciente, unidades asistenciales en drogodependencias y porcentaje de pacientes con dosis adecuadas) y tres de output (días de abstinencia de heroína en el último mes, tasas de retención y grado de mejoría de los problemas relacionados con el consumo). La matriz de datos generada se somete a análisis mediante el DEA. Resultados. El modelo ordena los programas en función de su nivel de eficiencia. Los programas P8, P9, P11, P5 y P6 son considerados "ineficientes" y se estiman las magnitudes de las variables de input y output que distan de un rendimiento óptimo. En este análisis, la variable de output que añade más eficiencia a los programas es el "número de días de abstinencia de heroína en el último mes" y la variable de input que añade más ineficiencia a los mismos, es el "porcentaje de pacientes con dosis adecuadas". Conclusión. El modelo DEA tiene una utilidad potencial para la medida comparativa de la eficiencia de PTO. La información aportada por este modelo podría ser utilizada por los coordinadores de programas para introducir cambios en los procesos terapéuticos con el objetivo de mejorar la calidad asistencial (AU)

Aim. To assess the usefulness of the mathematical model Data Envelopment Analysis (DEA) to measure the efficiency of opioid substitution programs (OSP). Material and Methods. A simulation study was conducted based on a series of assumptions that are tested using non-real data imputed from theoretical background. Fifteen hypothetical OSP are compared to estimate their relative efficiency. We obtained six variables from each program, three of which are considered input indices (therapists/patients ratio, number of treatment units and proportion of patients with adequate opioid doses), and the other three are considered output indices (number days of heroin abstinence in the last month, retention rates and degree of recovery from drug-use related problems). The data set was subjected to DEA analyses. Results. The DEA model ranked the OSP as a function of their efficiency levels. Programs P8, P9, P11, P5 and P6 were considered inefficient and the magnitude of the input and output variables were far from optimal achievement. In these analyses, the output variable that yielding a greater efficiency was the number days of heroin abstinence in the last month and the input variable providing greater inefficiency was the proportion of patients with adequate opioid doses. Conclusion. The DEA model yields can be useful to measure the relative efficiency of the OSP. The information provided by the model may be used by OSPs managers to introduce changes in therapeutic processes with the aim of increasing their quality (AU)

Self-regulation and treatment retention in cocaine dependent individuals: a longitudinal study.

BACKGROUND: We aimed to explore the association between baseline executive functioning and treatment outcome in Therapeutic Communities (TCs). METHODS: We used a longitudinal descriptive design: a baseline neuropsychological assessment was performed within the first 30 days of treatment in TCs. Once participants finished or abandoned treatment, the information about time of stay in treatment was computed for each individual. The study was conducted across six TCs located in the region of Andalusia (Spain): Cartaya, Almonte, Mijas, Los Palacios, La Línea, and Tarifa. Participants were 131 patients with cocaine dependence who initiated and finished treatment in TCs between January 2009 and December 2010 (2 years). Cognitive assessment was composed of general measures of executive functioning: Letter Number Sequencing (working memory) and Similarities (reasoning), and executive tasks sensitive to ventromedial prefrontal cortex dysfunction, including the Delis-Kaplan Stroop test (inhibition/cognitive switching), the Revised-Strategy Application Test (strategy application/multitasking), and the Iowa Gambling Task (decision-making). The outcome measure was retention, defined as time in TC treatment (number of days). RESULTS: Poor executive functioning significantly predicted shorter treatment retention in cocaine dependent individuals on TC residential treatment (14% of explained variance). Reduced performance on the R-SAT, a multitasking test taxing the ability to develop and apply the best strategy to organize multiple sub-routine tasks in order to achieve a long-term goal, was the most powerful predictor of treatment retention. CONCLUSIONS: Self-regulation deficits predict the capacity to remain in residential treatment among cocaine dependents.

Análisis de las diferencias en el perfil y patrón de consumo de drogas de hombres y mujeres que asisten a fiestas rave / Analysis of the differences in the profile and drug use patterns between male and female who attend raves

Objetivo. Estudios poblacionales muestran un consumo diferencial de drogas entre hombres y mujeres. Algunos trabajos han apuntado hacia las raves como una cultura andrógina donde las diferencias de género se diluyen. No obstante, las evidencias empíricas sobre el patrón diferencial según género en este contexto son escasas. Este estudio tiene como objetivo analizar las diferencias en el patrón de consumo de drogas y el perfil sociodemográfico de hombres y mujeres que asisten a fiestas rave. Material y método. Se entrevistó a 252 asistentes a fiestas rave en Andalucía (España). Se administró un cuestionario en el que se recogía información sobre el patrón de consumo de 15 drogas distintas y el perfil sociodemográfico. Resultados. Los resultados muestran un elevado consumo y policonsumo de drogas entre los participantes, no encontrándose diferencias significativas en el patrón de consumo y el perfil sociodemográfico según el género. Como media, los hombres han consumido alguna vez 9,9 drogas frente a 9,5 las mujeres. En el último mes, 7,3 frente a 6,9, y en la última rave, 5 frente a 4,9. Conclusiones. Al contrario de lo que sucede en la población general, donde la prevalencia de consumo de drogas de los hombres es superior a la de las mujeres, este trabajo no ha encontrado diferencias significativas en el patrón de consumo entre ambos géneros. Este hecho debe ser considerado para el diseño de estrategias preventivas de reducción de riesgos y daños en este colectivo (AU)

Objective. Population studies show differential drug consumption between male and female. Some studies point to rave as an androgynous culture, where gender differences disappear. Nonetheless, in this context, empirical evidences on differential patterns of drug use by gender are scarce. The purpose of this study is to analyze differences in drug use patterns and sociodemographic profile between male and female who attend raves. Material and method. Two hundred and fifty-two people who went to raves in Andalucía (Spain) were interviewed. It was administered a questionnaire to collect information on use patterns of 15 different drugs and sociodemographic profile. Results. Results show a high substance and polysubstance use between ravers. No significant differences by gender were found in drug use patterns or sociodemographic profile. The average number of drug consumed for male "some time in their lives" were 9.9, versus 9.5 for female. In the last month, 7.3 versus 6.9, and last rave, 5 versus 4.9. Conclusions. Opposite to what it happens in general population, where drug use prevalence of male is higher than female, this study haven´t found significant differences by gender. This fact must be considered in order to design risk and harm reduction preventive strategies (AU)

Estimation of cutoff for the Severity of Dependence Scale (SDS) for opiate dependence by ROC analysis.

BACKGROUND: The Severity of Dependence Scale (SDS) is a five-item scale that has been reported to be a reliable and valid screening instrument for dependence in several types of substances. Optimal cutoff points on the SDS indicative of clinically significant dependence have been determined for a large range of substance types, however, to date no data have been reported on its performance in a population with opiate dependence. SAMPLE: A structured interview was administered to 315 opiate-dependent patients in treatment. METHOD: The diagnostic performance of the SDS was measured via Receiver Operating Characteristic (ROC) analysis according to the DSM-IV diagnosis of heroin dependence, as measured by section 12 of the Schedule for Clinical Assessment in Neuropsychiatry (SCAN). RESULTS: ROC analysis revealed the SDS to be a test of high diagnostic utility for the measurement of opiate dependence (Area Under Curve =0.8875). The cut-off point on the SDS at which there is optimal discrimination between the presence and absence of a diagnosis of heroin dependence was found to be 5 (i.e. a score of 5 or more). This score provides the best trade-off between sensitivity (83.15%) and specificity (84.51%). Similar results were found for heroin current consumption (AUC = 0.8325; cut-off = 5; sensitivity = 77.94 and specificity = 77.33). CONCLUSION: The SDS can be recommended as an effective short instrument for the discrimination of the degree of dependency and heroin consumption in the clinical area.

Estimación de un punto de corte para la Escala de Severidad de la Dependencia (SDS) para la adicción a opiáceos mediante análisis ROC / Estimation of cutoff for the Severity of Dependence Scale (SDS) for opiate dependence by ROC analysis

Contexto. La escala de severidad de la dependencia (SDS)es una escala de cinco ítems que ha mostrado su fiabilidad y validez como instrumento de cribado de la dependencia en varios tipos de sustancias. El punto de corte óptimo de la SDS indicativo de la significación clínica de la dependencia ha sido determinado para un rango amplio de drogas, pero a día de hoy no se ha informado del valor del mismo para el caso de la dependencia a opiáceos. Muestra. Se ha administrado una entrevista estructurada a 315 personas con dependencia a opiáceos en tratamiento. Método. La capacidad diagnóstica de la SDS ha sido evaluada a través de análisis de la curva característica operativa del receptor (ROC) tomando como estándar el diagnóstico de dependencia según criterios DSM-IV a través dela sección 12 del SCAN. Resultados. El análisis ROC presenta la SDS como una prueba de alta utilidad diagnóstica para la valoración de la dependencia de opiáceos (Área Bajo la Curva = 0,8875). El punto de corte óptimo de la SDS para la discriminación entre la presencia y ausencia de diagnóstico de dependencia de opiáceos ha sido de 5 (una puntuación mayor o igual a 5), el cual presenta el mejor balance comparativo entre la sensibilidad (83,15%) y la especificidad (84,51%). Similares resultados se han encontrado para el consumo actual de heroína (ABC = 0,8325; Punto de corte = 5; Sensibilidad =77,94% y Especificidad = 77,33%).Conclusión. La escala SDS puede ser recomendada como un instrumento breve efectivo para la discriminación del grado de dependencia y consumo de heroína en el ámbito clínico (AU)

Background. The Severity of Dependence Scale (SDS) is a five-item scale that has been reported to be a reliable and valid screening instrument for dependence in several types of substances. Optimal cutoff points on the SDS indicative of clinically significant dependence have been determined for a large range of substance types, however, to date no data have been reported on its performance in a population with opiate dependence. Sample. A structured interview was administered to315 opiate-dependent patients in treatment. Method. The diagnostic performance of the SDS was measured via Receiver Operating Characteristic (ROC) analysis according to the DSM-IV diagnosis of heroin dependence, as measured by section 12 of the Schedule for Clinical Assessment in Neuropsychiatry (SCAN).Results. ROC analysis revealed the SDS to be a test of high diagnostic utility for the measurement of opiate dependence (Area Under Curve =0.8875). The cut-off point on the SDS at which there is optimal discrimination between the presence and absence of a diagnosis of heroin dependence was found to be 5 (i.e. a score of 5or more). This score provides the best trade-off between sensitivity (83.15%) and specificity (84.51%). Similar results were found for heroin current consumption (AUC = 0.8325; cut-off = 5; sensitivity = 77.94 and specificity = 77.33).Conclusion. The SDS can be recommended as an effective short instrument for the discrimination of the degree of dependency and heroin consumption in the clinical area (AU)

Diagnóstico del trastorno por déficit de atención e hiperactividad (TDAH) en pacientes adultos con dependencia de cocaína: utilidad de los nuevos síntomas de funcionamiento ejecutivo de Barkley / Diagnosing adult attention-deficit/hyperactivity disorder in patients with cocaine dependence: usefulness of new Barkley executive function symptoms

Objetivos: Estimación de la prevalencia del trastorno por déficit de atención e hiperactividad (TDAH) del adulto en una muestra de dependientes de cocaína y evaluación de la utilidad de los síntomas de funcionamiento ejecutivo de Barkley para diferenciar entre pacientes dependientes de cocaína con y sin TDAH. Métodos: Diseño observacional transversal. Se evaluó un total de 70 sujetos dependientes de cocaína que ingresaron para tratamiento en una comunidad terapéutica. Los sujetos seleccionados fueron citados para una entrevista cara a cara entre los días 15.º y 20.º del ingreso. Se utilizó una técnica de muestreo consecutivo no aleatorio. Se reclutó a los sujetos según acudían a la comunidad terapéutica y cumplían los criterios de selección. El instrumento de medida empleado para diagnosticar TDAH en la edad adulta fue la Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID). Los trastornos psiquiátricos comórbidos fueron evaluados según criterios DSM-IV-TR mediante la versión española de la entrevista Psychiatric Research Interview for Substance and Mental Disorders (PRISM-IV). Para la evaluación del "funcionamiento ejecutivo" empleamos el Current Behavior Scale Self-Report de Russell A. Barkley. Resultados: La prevalencia de TDAH observada en nuestra muestra fue del 14,3 % (intervalo de confianza [IC] 95 %: 6,1-22,5). Las puntuaciones medias en todos los ítems de la escala de Barkley son superiores en el grupo de pacientes diagnosticados de TDAH y dependencia a la cocaína, en comparación con los sujetos que sólo presentan dependencia a la esta sustancia, con diferencias estadísticamente significativas. Conclusiones: La prevalencia observada de TDAH en nuestra muestra fue elevada y se sitúa dentro del rango de las encontradas por otros autores en muestras similares. Los datos del estudio apoyan la teoría de Barkley en esta población (AU)

Objectives: Estimation of the prevalence of adult attention-deficit/hyperactivity disorder (ADHD) in a sample of cocaine users treated in a therapeutic community and evaluation of the usefulness of Barkley executive function symptoms in differentiating cocaine-dependent patients with and without ADHD. Methods: A transversal observation design was used. A total of 70 cocaine-dependent subjects who were admitted for treatment in a therapeutic community were assessed. Non-random consecutive sampling was used, recruiting the subjects as they arrived at the therapeutic community and met the selection criteria. Subjects included in the study were given an appointment for a face-to-face interview from 15 to 20 days after admission. The measurement instrument used for diagnosing adult ADHD was Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID). Comorbid psychiatric disorders were evaluated according to DSM-IV-TR criteria using the Spanish version of the Psychiatric Research Interview for Substance and Mental Disorders (PRISM-IV). For assessment of the "executive function", we used the Current Behavior Scale Self-Report by Russell A. Barkley. Results: The prevalence of ADHD observed in our sample was 14.3 % (confidence interval [CI] 95 %: 6.1-22.5). The mean scores on all the items on the Barkley scale are higher in the group of cocaine-dependent patients diagnosed with ADHD than for subjects who were cocaine-dependent only by a statistically significant difference. Conclusions: The high prevalence of ADHD observed in our sample was within the range found by other authors in similar samples. The study data support Barkley's theory in this population (AU)

Análisis cualitativo de la percepción del tratamiento con buprenorfina sublingual para la retirada del tratamiento con metadona / Qualitative analysis of patient perception of tapering off methadone treatment with sublingual buprenorphine

Objetivo. Diversos autores han puesto de relieve la importancia de incorporar a los estudios sobre tratamiento en drogodependencias indicadores que tomen en cuenta la percepción del paciente hacia el tratamiento y su satisfacción con el mismo. La percepción sobre el tratamiento influye sobre su aceptabilidad y, por lo tanto, sobre el seguimiento y la adherencia, modulando así su efectividad. El objetivo de este estudio es conocer la percepción y la satisfacción de los pacientes que participan en un estudio piloto de tratamiento con buprenorfina en comunidades terapéuticas y en un centro ambulatorio. Material y métodos. El estudio se ha desarrollado con una metodología cualitativa. Los participantes en el estudio han sido 18 pacientes que recibieron tratamiento en régimen residencial y ambulatorio, a los que se les realizó una entrevista semiestructurada. El análisis de los resultados se ha realizado a través del método de comparación constante, propuesto por la Teoría Fundamentada. Resultados. Los resultados obtenidos reflejan que los pacientes perciben una mayor comodidad en la retirada del tratamiento con buprenorfina, en comparación con la de metadona. Además, los pacientes perciben que el tratamiento con buprenorfina es más fácil de adaptar a la vida cotidiana, a lo que contribuiría una posible dispensación en farmacias. Igualmente, relatan que el estigma percibido asociado a este fármaco es menor en comparación con lo que representa estar en tratamiento con metadona. Conclusiones. Los participantes consideran que estas características y el menor efecto euforizante y sedante facilitan su proceso de incorporación social (AU)

Objective. Various authors have emphasized the importance of including treatment indicators that take into account patient perception of the treatment and his satisfaction with it in studies on drug addiction. Perception of the treatment influences its acceptability and therefore, whether it is followed and adhered to, thus modulating its effectiveness. The purpose of this study is to find outpatient perception and satisfaction with a pilot buprenorphine treatment study in therapeutic communities and one outpatient centre. Material and methods. The study was carried out with a qualitative methodology. The participants in the study were 18 patients that received treatment in therapeutic communities and one outpatient centre who were give n a semi-structured interview. Results: were analysed using the Constant Comparison Method, proposed by the Grounded Theory. Results. The results obtained show that the patients perceive they are more comfortable during withdrawal treatment with buprenorphine than with methadone. The patients further perceive that the buprenorphine treatment is easier to adapt to their daily lives, to which the possibility of dispensing it in pharmacies would contribute. They also say that the stigma associated with this pharmaceutical is less than with methadone. Conclusions. Patients think these characteristics and the absence of opioid effects facilitates the process of their incorporation in society (AU)

Escala de Adecuación de Dosis de Opiáceos (EADO): un nuevo instrumento para la evaluación clínica del ajuste de las dosis de metadona / The Opiate Dosage Adequacy Scale (ODAS): a new instrument for clinical assessment of adjusting methadone doses

Objetivo. Existe una marcada variabilidad inter-individual en la respuesta a una determinada dosis de metadona. Por esta razón, no debe hablarse de dosis «altas» o «bajas» tal como las definen los estudios epidemiológicos, sino de «dosis adecuadas» desde una perspectiva clínica individual. Hasta el momento no se ha publicado ningún instrumento que mida de forma global la adecuación de las dosis. El objetivo de la presente publicación es presentar y analizar la Escala de Adecuación de Dosis de Opiáceos (EADO). Material y métodos. El estudio, de diseño observacional, transversal y multicéntrico, se realizó sobre una muestra total de 300 pacientes en programa de tratamiento con metadona, seleccionados aleatoriamente de un total de 10 centros ambulatorios de tratamiento de conductas adictivas. La EADO es una entrevista clínica semiestructurada de 10 ítems que puede pasarse en 10-15 minutos y cuyo propósito es proporcionar una medida del grado en que una determinada dosis de metadona resulta «adecuada» para un paciente concreto. Resultados. Se presentan las evidencias psicométricas que avalan este uso publicadas previamente. La consistencia interna de la EADO es aceptable y la fiabilidad inter-examinadores es muy alta. El análisis factorial muestra una estructura formada por cuatro factores que coincide exactamente con las dimensiones del constructo «adecuación de dosis » propuestas a priori («síndrome de abstinencia a opiáceos», craving, «sobremedicación» y «consumo de heroína»). Conclusiones. La EADO mide el grado de adecuación o ajuste de las dosis de metadona que viene tomando el paciente. Este instrumento se ha mostrado útil en la práctica asistencial y en la investigación clínica, abriendo una interesante línea de estudio (AU)

Objectives.There are a lot of marked inter-individual variability in clinical response to one determinate methadone doses. For this reason, we should therefore not speak of «high» or «low» doses as defined in epidemiological studies, but «adequate dose» from an individual clinical perspective. So far no evidence has been published of a tool capable of providing a global measurement of dose adequacy. The purpose of this paper is to explain and to analize the Opiate Dosage Adequacy Scale (ODAS). Material and methods. One multicentric, observational and cross-sectional study design was performed on a total sample of 300 randomized opiatedependent out-patients treated in a methadone maintenance program (MMP) in 10 outpatient public centres. The Opiate Dosage Adequacy Scale (ODAS) is a brief semi-structured clinical interview (10 items, ruled in 10-15 minutes) whose purpose is to clinically assess how adequate the methadone dose prescribed in the context of the patient’s methadone maintenance program is to his or her individual needs. Results. The psychometrics propierties to support this use are explained, published previously. Internal consistency for the ODAS was acceptable. Very high inter-rater reliability was found across items. The factor analysis yielded a four factor structure exactly coinciding with the dimensions of the «dose adequacy» construct proposed a priori («opiate withdrawal syndrome», «craving», «overmedication » and «heroin use»). Conclusions. The ODAS attempts to provide clinical measurements of the degree to which a given methadone dose is «adequate» for an individual patient. This instrument can be one useful tool for clinical practice and clinical research, opening one interesting reseach line (AU)

Aspectos farmacológicos de los programas de tratamiento con buprenorfina-naloxona / Pharmacological aspects of the buprenorhine-naloxona treatment programmes

Objetivo. El objetivo del presente trabajo es realizar una revisión conceptual sobre los principales aspectos farmacológicos que fundamentan el uso clínico de la buprenorfina/naloxona. Material y métodos. Se realiza una búsqueda bibliográfica y se revisan las principales guías clínicas de buena práctica sobre el tratamiento con buprenorfina y buprenorfina/naloxona. Se seleccionan las recomendaciones coincidentes y se realiza una síntesis actualizada desde una orientación clínica práctica. Resultado. La buprenorfina/naloxona es un producto con un perfil farmacológico eficaz y seguro para el tratamiento de la dependencia de opiáceos. Como agonista parcial de los receptores opiáceos µ y antagonista de los receptores opiáceos k, ofrece ciertas ventajas para un determinado grupo de pacientes dependientes de los opiáceos, a pesar de que la metadona seguirá siendo el fármaco de primera elección para la mayoría. La fase de inducción es un proceso seguro y cómodo para la mayoría de los pacientes, siendo fundamental una correcta y suficiente información. Se constata una estrecha relación entre el tiempo del paciente en tratamiento y los resultados del programa. Debido a su prolongada vida media, la retirada del fármaco es cómoda para el paciente, sin la presencia de síntomas de abstinencia significativos. Conclusiones. La buprenorfina/naloxona va a ocupar el «espacio» existente entre los programas de tratamiento con agonistas (metadona) y los denominados «programas libres de drogas». Se trata de un fármaco eficaz y seguro que debe emplearse en el contexto de un programa de intervención psicosocial más amplio

Objectives. The aim of this work is to carry out a conceptual review of the main pharmacological aspects on which the clinical use of buprenorphine/naloxone is based. Materials and methods. A bibliographical search is done, and the major clinical guides are reviewed for good practice in treatment with buprenorphine and buprenorphine/nolaxone. The recommendations they have in common are selected and an updated synthesis is carried out from a clinical practice viewpoint. Results. Buprenorphine/naloxone has a safe and efficient pharmacological profile for the treatment of dependence on opiates. As a partial agonist of the opiate µ receptors and antagonist of the opiate k receptors, they offer certain advantages for a particular group of opiate addicts, even though methadone will continue to be the first choice for most such patients. The induction phase, in which sufficient, and correct information is essential, is a safe and easy process for most patients. The time the patient is treated and the programme results are closely related. Due to the prolonged half-life of this medicament, there are no significant withdrawal symptoms when patients end treatment. Conclusions. Buprenorphine/naloxone will cover the existing «gap» between treatment programmes using agonist (methadone) and the so-called «drug-free programmes». It is a safe and effective medicament that should be used in the context of a wider programme of psycho-social intervention

Inducción a buprenorfina sublingual desde metadona: estudio clínico descriptivo en una muestra de pacientes tratados en una comunidad terapéutica / Induction from methadone to sublingual buprenorphine: a descriptive clinical trial in a methadone patients sample treated in therapeutic communities

Objetivo. Descripción y evaluación clínica del proceso de inducción a buprenorfina sublingual (Subutex®) en el contexto de una comunidad terapéutica, en pacientes que venían tomando metadona. Material y métodos. Estudio observacional (descriptivo), longitudinal prospectivo y abierto (diseño antes-después). Se utilizó un procedimiento de muestreo consecutivo no probabilístico. Una muestra de pacientes en tratamiento con metadona que ingresaron en una comunidad terapéutica fueron transferidos a buprenorfina sublingual (Subutex®). Posteriormente, las dosis de este fármaco se fueron reduciendo hasta su retirada dentro de un período de 16 semanas. Los pacientes cumplían criterios DSM-IV de dependencia de opiáceos, eran mayores de edad y firmaron un consentimiento informado. Todos los pacientes fueron evaluados antes y después de la toma de buprenorfina durante los cinco días que duró la inducción. El protocolo del estudio fue aprobado por el Comité Autonómico de Ensayos Clínicos de Andalucía y se ha desarrollado de acuerdo con la Declaración de Helsinki. Como medidas se han utilizado la Objective Opiate Withdrawal Scale (OOWS), la Subjective Opiate Withdrawal Scale (SOWS), el Test para la Evaluación de la Calidad de Vida en Adictos a Sustancias Psicoactivas (TECVASP), el General Health Questionnaire (GHQ-28), el Opiate Treatment Index (OTI) y el Schedules for Clinical Assessment in Neuropsychiatry (SCAN). Resultados. Un total de 119 pacientes cumplieron los criterios de selección. De éstos, 46 sujetos fueron transferidos desde metadona a buprenorfina, mientras que los 73 restantes decidieron permanecer en tratamiento con metadona. Se observa una reducción de casi dos tercios en las puntuaciones de las escalas de abstinencia entre ambos momentos de la evaluación. Esta diferencia fue estadísticamente significativa tanto para el síndrome de abstinencia a opiáceos (SAO) objetivo (t = 4,679; g.l. = 44; p < 0,000) como para el SAO subjetivo (t = 4,886; grados de libertad (g.l.) = 44; p < 0,000). A medida que se incrementaban día a día las dosis medias de Subutex® los síntomas de abstinencia fueron disminuyendo durante los tres primeros días y, a partir del cuarto día, el SAO prácticamente habían desaparecido. Conclusiones. Los datos de este trabajo aportan más evidencias sobre la efectividad farmacológica, la seguridad y la comodidad del proceso de transferencia desde el tratamiento con metadona al de buprenorfina

Objective. Description and clinical assessment of buprenorphine induction in a sample of opiate-dependent patients transferred from methadone in therapeutic communities. Material and methods. Observational (descriptive), open longitudinal prospective study («before-after» design). A non-probabilistic consecutive sampling procedure was used. A sample of patients in treatment with methadone who were admitted to five therapeutic communities was transferred to buprenorphine induction (Subutex®). When it was considered appropriate, gradual reduction was begun to reduce the buprenorphine dose to 0 mg within 16 weeks. The patients met DSM-IV-TR criteria for Opiate Dependence, were adults and signed an informed consent release. All of the patients were evaluated at three times; baseline assessment (Mo), after one month of treatment (M1) and after three months (M2). The study protocol was approved by the Andalusian Regional Committee for Clinical Trials, and was conducted in accordance with the Declaration of Helsinki. The measurement instruments are: The Objective Opiate Withdrawal Scale (OOWS), the Subjective Opiate Withdrawal Scale (SOWS), the Health Related Quality of Life for Drug Abusers Test (HRQoLDA Test), the General Health Questionnaire (GHQ-28), the Opiate Treatment Index (OTI) and the Schedules for Clinical Assessment in Neuropsychiatry (SCAN). Results. A total of 119 patients met the selection criteria. Of these, 46 subjects were transferred from methadone to buprenorphine, while the remaining 73 decided to stay on their methadone maintenance treatment. A clinically significant reduction in opiate withdrawal scores between assessment points was observed. This differences was statistically significant too for objective OWS (t = 4,679; g.l. = 44; p < 0,000) and for subjective OWS (t = 4,886; g.l. = 44; p < 0,000). The day by day increment of Subutex® doses was associated to go down withdrawal symptoms during the first three days. From fourth day to forward the OWS symptoms was negligible. Conclusions. Data of this paper provide more evidences about pharmacologic effectiveness, security and comfort of transfer from methadone to buprenorphine process

Aspectos farmacoeconómicos de los tratamientos con buprenorfina / Pharmacoeconomic aspects of treatments with buprenorphine

Objetivo: Establecer una opinión formadaacerca de las evidencias farmacoeconómicasde los tratamientos con buprenorfina.Material y métodos: Revisión bibliográfica no sistemáticay valoración crítica de los estudios de evaluacióneconómica sobre este tratamiento.Resultados: El número de estudios encontradoses muy limitado. La mayoría son análisis de costeefectividadque tratan de comparar los tratamientosde buprenorfina con los de metadona. En términosglobales, la metadona es la alternativamenos costosa y la más efectiva pero, al compararlas razones efectividad/coste, no se observan diferenciassignificativas.Conclusiones: La evidencia farmacoeconómicaes aún insuficiente para extraer conclusiones relevantes.No obstante, hay datos que apoyan la utilidadde los tratamientos con buprenorfina paraalgunas tipologías de pacientes. Debería incorporarsela perspectiva del usuario ante la decisión sobrela financiación de este fármaco

Objectives: The development of anscientific-based opinion on buprenorphine treatmentevidence-based pharmacoeconomics.Material and methods: Non-systematized, criticaland bibliographic revision of published clinicaltrials and revision on economic evaluation on thistreatment.Results: The number of papers published is veryscarce. The greater part of this are cost-effectivenessstudies on methadone maintenance treatmentvs. buprenorphine maintenance treatment. In globalsense, the most effective and in low cost alternativeis methadone program, however, there arenot statistical differences in the effective/cost ratios.Conclusions: The evidence-based pharmacoeconomicsis non-sufficient in order to obtain relevantconclusions. However, some informations confirmthe usefulness of buprenorphine for several patientstipologies. It is necessary to include the patientopinions on the decision-making process onbuprenorphine financing

Documento de consenso de la sociedad Española de toxicomanías sobre el empleo y la disponibilidad de la buprenorfina para el tratamiento de la dependencia de opiáceos en España / SET position paper. Buprenosphine in the treatment of opioid dependence in Spain

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Feasibility, reliability and validity of the Spanish version of Psychiatric Assessment Schedule for Adults with Developmental Disability: a structured psychiatric interview for intellectual disability.

BACKGROUND: Over 30% of people with intellectual disability (ID) have a comorbid psychiatric disorder. However, there are few assessment instruments available for international use and cross-cultural validation studies of these instruments are rare. The aim of the present study was to standardize the Spanish version of the Psychiatric Assessment Schedule for Adults with Developmental Disability (PAS-ADD-10), a semi-structured interview for people with ID. METHODS: After a conceptual translation, feasibility (i.e. applicability, acceptability and practicality) and reliability analyses were carried out. The predictive validity of the PAS-ADD-10 CATEGO-5 codings was also examined (i.e. positive and negative predictive values). Four independent raters with wide-ranging experience in quantitative evaluation and psychiatric assessment of ID evaluated a sample of 80 subjects with ID and borderline intellectual functioning at the AFANAS occupational centre in Jerez, Southern Spain. The ICD-10 codes were used for psychiatric diagnosis. RESULTS: The practicality of the PAS-ADD-10 is limited because of the need for previous standardization of SCAN interviews. Nevertheless, its overall feasibility was judged adequate by raters and the PAS-ADD-10 was considered extremely useful for training. Test-retest and inter-rater reliability kappa values were moderate to high. The CATEGO coding showed limited validity because of overdiagnosis of anxiety disorders and underdiagnosis of mood and psychotic disorders (positive predictive value = 74%, negative predictive value = 76%). CONCLUSIONS: The PAS-ADD-10 is a useful tool for standard psychiatric assessment of people with ID; however, CATEGO codings show low validity and a series of modifications should be considered before this instrument is used extensively in Spain. In this regard, a study on the clinical usefulness of the PAS-ADD-10 in patients with ID and severe mental disorders has been undertaken.

[Drug dependent patients in the methadone maintenance program: evaluation in primary care of psychosocial and organic severity]. / Pacientes toxicómanos en Programa de Mantenimiento con Metadona: evaluación del perfil de gravedad psicosocial y orgánico en atención primaria.

OBJECTIVE: To describe the profile of bio-psycho-social gravity in opiate-dependent patients in the Methadone Maintenance Programme. DESIGN: A descriptive crossover study. SETTING: Primary Care Centre. PATIENTS: 31 heroin-dependent patients on Methadone treatment at a drug-dependency care centre who attended the Health Centre for drug dispensing, between February and December 1996. MEASUREMENTS AND MAIN RESULTS: All patients were given the semi-structured clinical interview Opiate Treatment Index (OTI) and filled in the self-administered APGAR family questionnaire. 48.3% had little deterioration in their "General Health Status" section and 54.8% had low scores in "Conduct causing risk of HIV contagion". CONCLUSIONS: The observed data are consistent with the results to be expected in this kind of programme. The multidimensional evaluation instruments are a tool that can be used to tackle drug-dependent patients in Primary Care.