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1.
Addiction ; 111(8): 1416-27, 2016 08.
Artículo en Inglés | MEDLINE | ID: mdl-26948856

RESUMEN

AIMS: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone(®) ) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol(®) ) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. METHODS: This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. RESULTS: No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. CONCLUSIONS: Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.


Asunto(s)
Analgésicos Opioides/uso terapéutico , Combinación Buprenorfina y Naloxona/uso terapéutico , Trastornos Relacionados con Cocaína/tratamiento farmacológico , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico , Administración Oral , Adulto , Terapia Cognitivo-Conductual , Preparaciones de Acción Retardada , Método Doble Ciego , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
2.
J Subst Abuse Treat ; 44(1): 103-14, 2013 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-22657748

RESUMEN

AIMS: The study evaluated the effectiveness of an 8-week combined group plus individual 12-step facilitative intervention on stimulant drug use and 12-step meeting attendance and service. DESIGN: Multisite randomized controlled trial, with assessments at baseline, mid-treatment, end of treatment, and 3- and 6-month post-randomization follow-ups (FUs). SETTING: Intensive outpatient substance treatment programs. PARTICIPANTS: Individuals with stimulant use disorders (n = 471) randomly assigned to treatment as usual (TAU) or TAU into which the Stimulant Abuser Groups to Engage in 12-Step (STAGE-12) intervention was integrated. MEASUREMENTS: Urinalysis and self-reports of substance use and 12-step attendance and activities. INTERVENTION: Group sessions focused on increasing acceptance of 12-step principles; individual sessions incorporated an intensive referral procedure connecting participants to 12-step volunteers. FINDINGS: Compared with TAU, STAGE-12 participants had significantly greater odds of self-reported stimulant abstinence during the active 8-week treatment phase; however, among those who had not achieved abstinence during this period, STAGE-12 participants had more days of use. STAGE-12 participants had lower Addiction Severity Index Drug Composite scores at and a significant reduction from baseline to the 3-month FU, attended 12-step meetings on a greater number of days during the early phase of active treatment, engaged in more other types of 12-step activities throughout the active treatment phase and the entire FU period, and had more days of self-reported service at meetings from mid-treatment through the 6-month FU. CONCLUSIONS: The present findings are mixed with respect to the impact of integrating the STAGE-12 intervention into intensive outpatient drug treatment compared with TAU on stimulant drug use. However, the results more clearly indicate that individuals in STAGE-12 had higher rates of 12-step meeting attendance and were engaged in more related activities throughout both the active treatment phase and the entire 6-month FU period than did those in TAU.


Asunto(s)
Estimulantes del Sistema Nervioso Central/efectos adversos , Cooperación del Paciente , Grupos de Autoayuda , Trastornos Relacionados con Sustancias/rehabilitación , Adulto , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , National Institute on Drug Abuse (U.S.) , Recurrencia , Derivación y Consulta/organización & administración , Índice de Severidad de la Enfermedad , Detección de Abuso de Sustancias , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
3.
J Subst Abuse Treat ; 44(4): 426-32, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23007109

RESUMEN

Absence of successful transition to post-detoxification treatment leads to high rates of relapse among detoxified heroin users. The present study evaluated a pilot buprenorphine treatment program (BTP). Heroin dependent individuals were inducted onto buprenorphine/naloxone in detox, maintained while transitioning through an intensive inpatient program (IIP), and gradually tapered off medication over 5 months of outpatient (OP) treatment. Compared to programmatic indicators of treatment engagement in the year prior to BTP implementation, referrals from detox to IIP, entry into and completion of IIP and subsequent OP, and days in OP treatment increased substantially. BTP completers, compared to non-completers, viewed abstinence as more difficult and as requiring more assistance to achieve, were less likely to be current cocaine and alcohol users or to have relapsed during the course of treatment. Although preliminary and in need of replication, initial adjunctive use of buprenorphine in an abstinence-based continuum of care may improve post-detoxification treatment entry, engagement, and completion.


Asunto(s)
Buprenorfina/uso terapéutico , Dependencia de Heroína/rehabilitación , Antagonistas de Narcóticos/uso terapéutico , Adolescente , Adulto , Alcoholismo/complicaciones , Alcoholismo/rehabilitación , Atención Ambulatoria , Trastornos Relacionados con Cocaína/complicaciones , Trastornos Relacionados con Cocaína/rehabilitación , Interpretación Estadística de Datos , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Personal de Salud , Dependencia de Heroína/tratamiento farmacológico , Humanos , Renta , Tiempo de Internación , Masculino , Cooperación del Paciente , Selección de Paciente , Proyectos Piloto , Recurrencia , Factores Socioeconómicos , Adulto Joven
4.
J Psychoactive Drugs ; 38(4): 505-12, 2006 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-17373566

RESUMEN

Previous studies indicate that buprenorphine has efficacy in medically supervised opioid withdrawal, but the optimal dosing for maximum tolerability and ease of administration remains undetermined. Five heroin-dependent individuals entered this open-label study of inpatient detoxification with a single 24 mg dose of buprenorphine. The mean Clinical Opiate Withdrawal Scale (COWS) score prior to buprenorphine administration was 17.6 (SD = 3.36). COWS scores declined significantly thereafter. There was one episode of precipitated withdrawal that resolved within four hours. Use of ancillary medications was minimal. This study suggests that a single high dose of buprenorphine can be used safely and effectively for inpatient detoxification.


Asunto(s)
Buprenorfina/uso terapéutico , Dependencia de Heroína/tratamiento farmacológico , Síndrome de Abstinencia a Sustancias/tratamiento farmacológico , Adulto , Buprenorfina/administración & dosificación , Buprenorfina/efectos adversos , Femenino , Humanos , Masculino , Proyectos Piloto
5.
Drug Alcohol Depend ; 77(1): 71-9, 2005 Jan 07.
Artículo en Inglés | MEDLINE | ID: mdl-15607843

RESUMEN

The optimum dose of buprenorphine for acute inpatient heroin detoxification has not been determined. This randomized, double-blind, double-dummy, pilot study compares two buprenorphine sublingual tablet dosing schedules to oral clonidine. Heroin users (N = 30) who met DSM-IV criteria for opioid dependence and achieved a Clinical Opiate Withdrawal Scale (COWS) score of 13 (moderate withdrawal), were randomized to receive higher dose buprenorphine (HD, 8-8-8-4-2 mg/day on days 1-5), lower dose buprenorphine (LD, 2-4-8-4-2 mg/day on days 1-5), or clonidine (C, 0.2-0.3-0.3-0.2-0.1 mg QID on days 1-5). COWS scores were obtained QID. Twenty-four hours after randomization, the percentages of subjects who achieved suppression of withdrawal, as defined by four consecutive COWS scores <12, were: C = 11%, LD = 40%, and HD = 60%. Generalized estimating equation regression models, controlling for baseline COWS and time, indicated that COWS scores over the course of 5 days were lower in both LD and HD compared to C (chi(2)(2) = 13.28, P = 0.001). Similar analyses examining scores over time on the Adjective Rating Scale for Withdrawal (ARSW) and on a Visual Analog Scale of Opiate Craving (VAS) indicated an overall treatment effect on the VAS accounted for by a significant difference between HD and C, but no overall treatment effect on the ARSW. There were no discontinuations due to treatment-related adverse events. Both HD and LD regimens are safe and efficacious treatment for opioid detoxification, but HD demonstrated superiority to C on a greater number of measures.


Asunto(s)
Analgésicos Opioides/uso terapéutico , Buprenorfina/uso terapéutico , Dependencia de Heroína/tratamiento farmacológico , Receptores Opioides mu/agonistas , Adulto , Analgésicos Opioides/farmacología , Análisis de Varianza , Buprenorfina/farmacología , Clonidina/farmacología , Clonidina/uso terapéutico , Método Doble Ciego , Femenino , Estudios de Seguimiento , Dependencia de Heroína/psicología , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Estudios Prospectivos , Receptores Opioides mu/fisiología , Factores de Tiempo
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