RESUMEN
OBJECTIVE: Preclinical studies and early pilot clinical investigations have suggested that N-acetylcysteine (NAC) may be useful in treatment of methamphetamine (METH) dependence. The present study evaluated whether NAC would suppress craving to the METH. METHODS: In a double-blind, controlled crossover clinical trial, 32 METH-dependent volunteers were chosen to receive either NAC (1200 mg/day) or placebo, randomly. They were intervened in two four-week sessions. During first session they received either 1200 mg/day of NAC (group A) or placebo (group B). After three days of washout period, next session started with the crossover intervention of the previous regimen. During these eight weeks, all participants received standardized, and Matrix Model of treatment. Craving was assessed using the Cocaine Craving Questionnaire-Brief (CCQ-Brief). The data were analyzed using SPSS version 20.0 (SPSS Inc. Chicago, Illinois, USA). RESULTS: In 23 subjects who completed the study, the mean score of CCQ-Brief reduced in four consecutive weeks with NAC treatment. The mean (SD) scores of carving in group A and B were 3.38 (1.16) and 5.96 (1.03), at the end of first session; and 4.57 (1.88) and 3.2 (0.86), at the end of the second session, respectively. Our findings indicate that the main effect was significant for NAC (P < 0.001). Across placebo and NAC conditions, only mild side effects were noted, and the number of subjects who reported side effects did not differ. CONCLUSION: The NAC showed good efficacy in suppressing METH craving, and may be a useful pharmacological treatment for METH dependency.
Asunto(s)
Acetilcisteína/uso terapéutico , Trastornos Relacionados con Anfetaminas/tratamiento farmacológico , Depuradores de Radicales Libres/uso terapéutico , Síndrome de Abstinencia a Sustancias/tratamiento farmacológico , Adulto , Estimulantes del Sistema Nervioso Central/efectos adversos , Ansia , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Metanfetamina/efectos adversos , Síndrome de Abstinencia a Sustancias/etiología , Encuestas y Cuestionarios , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Nicotine replacement therapy (NRT) with gradual decreasing of nicotine is one of the smoking cessation methods. Muccoadhesive formulations are among the novel drug delivery systems that are available in the form of tablets and films, and can be used for NRT. Muccoadhesive nicotine tablets when placed in the upper gum will attach to the buccal mucosa and release nicotine content in a controlled manner. This will meet the immediate and long-term need of the individual to the nicotine, such that the person can decrease his/her dependency on smoking.[1]. MATERIALS AND METHODS: In this study, the tablets were prepared using different conventional bioadhesive polymers such as Hydroxypropyl Methycellulose (HPMC) 50cps, sodium carboxy methyl cellulose (NaCMC), and carbapol 934 (CP934) in singular or mixture form. Magnesium hydroxide were used as the pH increasing agent; magnesium stearate as the lubricant; and lactose as the excipiente. Nicotine hydrogen bitartrate, more stable than the liquid, was used in different formulations. Pharmaceutics characteristics such as adhesion degree and drug release rate were evaluated. RESULTS: Increasing of HPMC 50cps in the formulations decrease speed release of nicotine. The carbapol in formulations beget slow releasing of nicotine. With increasing the percent of lactose, the rate of release in formulations was increased. Formulations, which have HPMC 50cps has best adhesiveness and the formulations contains carbapol had not suitable adhesiveness. Formulations contains NaCMC were very fast release and had not suitable adhesiveness. CONCLUSION: The formulation contains mixture of HPMC50cps and CP934 was the best because of suitable adhesiveness and minimum swing in release.