Efficacy of Atomoxetine for methamphetamine users who are on methadone maintenance treatment(Randomized, double-blind, placebo-controlled clinical trials)

Vice chancellor for research,Kashan University of Medical Sciences0 个研究点目标入组 82 人开始时间: 待定最近更新: 2018年2月22日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 82

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 years 至 50 years（—）
性别: All

入选标准

•Inclusion Criteria:18-65 years old? On Methadone maintenance treatment? Seeking treatment for METH use? METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV? At least weekly self-reported METH use during a preceding three month period? Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing, and not be nursing? Men must agree to use effective means of contraception during the study.

排除标准

•Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician? Current opioid, alcohol or sedative physical dependence or cocaine dependence? Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, hypertension [i.e., > 160 SBP or > 100 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician? Schizophrenia or bipolar disorder of any type? present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with atomoxetine (e.g., an monoamine oxidase inhibitor (MAOI), paroxetine, fluoxetine, quinidine, dopamine, albuterol, or other ß2-agonists)? Medical contraindication to receiving atomoxetine (e.g., severe hepatic impairment, glaucoma, heart disease, hypertension, seizure disorders, documented hypersensitivity to atomoxetine); or other bronchospastic condition, (2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to atomoxetine)? Liver function tests (i.e., liver enzymes) greater than two times normal levels? Systolic blood pressure of < 90 or > 160 mmHg, diastolic blood pressure of < 60 or > 100 mmHg, or sitting heart rate of < 55 or > 100 beats/min or blood pressure readings > 140 systolic or > 90 diastolic on three separate, consecutive occasions? History of pheochromocytoma? Metabolic diseases such as diabetes and neurological diseases such as epilepsy? Pregnant or nursing female

研究者

发起方

Vice chancellor for research,Kashan University of Medical Sciences

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