NCT00733239已完成1 期
Drug Discrimination in Methadone-Maintained Humans Study 2
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Drug Discrimination Performance
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
- 主要目的
- Basic Science
- 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 month 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
- •Unstable medical condition or stable medical condition that would interact with study medications or participation.
- •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 (< 1 week) use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. Recent use will be defined based upon the pharmacokinetics of the drug and dosing schedule. Thus, a short-acting antihistamine taken as needed (e.g., once the night before) will not necessarily rule out a participant; however,
- •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 (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- •ECG abnormalities including but not limited to: bradycardia (<60 bpm); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
研究组 & 干预措施
1
Experimental
Receives 2-4 of the drugs listed under Intervention
干预措施: 2-4 of the drugs listed below (Drug)
结局指标
主要结局
Drug Discrimination Performance
时间窗: Every Session
次要结局
- Self-report Ratings(Every Session)
- Vital Signs(Every Session)
- ECG(Test Sessions)
研究者
研究点 (1)
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