Drug Discrimination in Methadone-Maintained Humans Study 1

University of Arkansas1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2006年9月最近更新: 2011年3月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: University of Arkansas
入组人数: 40
试验地点: 1
主要终点: Drug Discrimination Measure

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Must be between the ages of 18-
•Participation in the UAMS Substance Abuse Treatment Clinic Methadone Maintenance Program or the CATAR Clinic Little Rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry.
•Subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. This would be defined as < 3 missed methadone medications and missed < 3 group or <3 individual therapy sessions in the two months prior to study participation
•Subjects must submit a urine sample negative for illicit drugs prior to study entry.
•Subjects must be able to read and understand English.

排除标准

•Exclusion criteria
•Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
•Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
•History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
•Pregnancy, plans to become pregnant or inadequate birth control.
•Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested.
•History of severe reaction to Narcan challenge, which may have been given as part of admission into the Methadone Maintenance Program or to reverse overdose.
•Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
•EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged with QTc interval (>420 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.