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临床试验/NCT03075501
NCT03075501已完成4 期

Drug Contextual Conditioning With in Humans: Causes and Consequences

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
133
试验地点
1
主要终点
Change in Time Spent in Drug-paired Room

研究概览

简要总结

The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.

详细描述

Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • past use of stimulants
  • bmi 19-26
  • hormonal birth control for women

排除标准

  • current or recent (Past year) history of major axis I disorder

研究组 & 干预措施

Paired

Active Comparator

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room.

干预措施: Paired (Behavioral)

Paired

Active Comparator

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room.

干预措施: Stimulant or sedative (Drug)

Paired

Active Comparator

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in only one room.

干预措施: Placebo (Drug)

Unpaired

Other

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms.

干预措施: Stimulant or sedative (Drug)

Unpaired

Other

Individuals receive drug (stimulant, or sedative) on two separate occasions and placebo on two separate occasions. Individuals receive drug in both rooms.

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Time Spent in Drug-paired Room

时间窗: Measured through study completion (maximum 5 weeks).

The amount of time spent in the two testing rooms is assessed during a 10min exploration test conducted at the orientation session (pre-test) and again at the testing session (post-test). Between the pre- and post-tests, participants complete 4 drug administration sessions; 2 with 20mg MA, 2 with 0mg MA. The Paired Group always receives 20mg MA in the room they spent the least time in at pre-test, and 0mg MA in the other room. The Unpaired Group receives 20mg MA and 0mg MA once in each room. The research question is whether the Paired Group spends significantly more time in the room paired with 20mg MA in comparison to the Unpaired Group. Thus, the outcome measure is the difference in time spent in the room paired with drug administration (i.e. the room that they spent the least time in at pre-test) between pre- and post-tests (i.e., post-test time spent - pre-test time spent) which is compared between the groups. NOTE: Time spent is NOT obtained during drug administration sessions.

次要结局

  • Subjective Drug Effects(Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma Childs

Associate Professor

University of Illinois at Chicago

研究点 (1)

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