跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01500018
NCT01500018撤回1 期

A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users

AstraZeneca0 个研究点开始时间: 2012年1月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
发起方
AstraZeneca
主要终点
Momentary Drug Liking VAS maximum effect (Emax)
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记录与标识符相似试验

研究概览

简要总结

This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to placebo, ketamine, and phentermine in healthy recreational polydrug users.

详细描述

A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Current recreational polydrug users with experience with at least 2 drug classes of abuse.
  • •At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA [ecstasy], LSD, mesacline, or psilocybin).
  • •Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates).
  • •Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening.
  • •Must pass qualification phase eligibility criteria.

排除标准

  • •Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation).
  • •Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up.
  • •Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
  • •Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation.
  • •Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours.
  • •Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).

研究组 & 干预措施

Crossover Treatment Sequence 1

Experimental

Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 1

Experimental

Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 1

Experimental

Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 1

Experimental

Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 2

Experimental

Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 2

Experimental

Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 2

Experimental

Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 2

Experimental

Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 3

Experimental

Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 3

Experimental

Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 3

Experimental

Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 3

Experimental

Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 4

Experimental

Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 4

Experimental

Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 4

Experimental

Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 4

Experimental

Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 5

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 5

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 5

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 5

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 6

Experimental

Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 6

Experimental

Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 6

Experimental

Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 6

Experimental

Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 7

Experimental

Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 7

Experimental

Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 7

Experimental

Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 7

Experimental

Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 8

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 8

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 8

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 8

Experimental

Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 9

Experimental

Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7:

Phentermine 45 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 9

Experimental

Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7:

Phentermine 45 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 9

Experimental

Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7:

Phentermine 45 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 9

Experimental

Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7:

Phentermine 45 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 10

Experimental

Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 10

Experimental

Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 10

Experimental

Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 10

Experimental

Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 11

Experimental

Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 11

Experimental

Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 11

Experimental

Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 11

Experimental

Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 12

Experimental

Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 12

Experimental

Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 12

Experimental

Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 12

Experimental

Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 13

Experimental

Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 13

Experimental

Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 13

Experimental

Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 13

Experimental

Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg

干预措施: Phentermine (Drug)

Crossover Treatment Sequence 14

Experimental

Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg

干预措施: TC-5214 (Drug)

Crossover Treatment Sequence 14

Experimental

Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg

干预措施: TC-5214 Placebo (Drug)

Crossover Treatment Sequence 14

Experimental

Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg

干预措施: Ketamine (Drug)

Crossover Treatment Sequence 14

Experimental

Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg

干预措施: Phentermine (Drug)

结局指标

主要结局

Momentary Drug Liking VAS maximum effect (Emax)

时间窗: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.

次要结局

  • Momentary Drug Liking VAS minimum effect (Emin)(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Drug Liking VAS time-weighted mean (TWmean)(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Overall Drug Liking VAS maximum effect ( Emax)(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Overall Drug Liking VAS (Emin)(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Overall Drug Liking VAS 10-hour mean score(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose)
  • Overall Drug Liking VAS 24-hour mean score(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Take Drug Again VAS Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Take Drug Again VAS 10-hour mean score(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose)
  • Take Drug Again VAS 24-hour mean score(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Subjective Drug Value Emax(10 and 24 hours post dose)
  • Subjective Drug Value 10 hour mean score(10 hours post dose)
  • Subjective Drug 24 hour mean scores(10 and 24 hours post dose)
  • High VAS Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • High VAS TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Good Effects VAS Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Good Effects VAS TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Bad Effects VAS Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Bad Effects VAS TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI dysphoria scale (LSD) Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI dysphoria scale (LSD) TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI sedation scale (PCAG) Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI sedation scale (PCAG) TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Alertness/Drowsiness VAS Emin (drowsiness)(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Alertness/Drowsiness VAS TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Any Effects VAS Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Any Effects VAS TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Bowdle VAS Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • Bowdle VAS TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI A scale Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI A scale TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI Phentermine and Benzedrine Group scale (BG) Emax(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)
  • ARCI Phentermine and Benzedrine Group scale (BG) TWmean(0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

相似试验

终止
1 期
Determining Highest Dose Administration of TC-5214 and Evaluating Effect on the Electrical Activity in the HeartHealthy Male
NCT01359618AstraZeneca16
已完成
3 期
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.Major Depressive Disorder
NCT01197508AstraZeneca696
已完成
3 期
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive DisorderMajor Depressive DisorderMDDDepression
NCT01152554AstraZeneca813
已完成
3 期
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)Major Depressive DisorderDepression
NCT01157078AstraZeneca319
已完成
3 期
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive DisorderMajor Depressive DisorderDepression
NCT01180400AstraZeneca295