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临床试验/NCT03954938
NCT03954938终止早期 1 期

Influence of Craving Manipulation on Cocaine Self-Administration

William Stoops1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
终止
入组人数
5
试验地点
1
主要终点
Number of Times Cocaine Was Selected

研究概览

简要总结

The specific aim of this project is to demonstrate that the decisional analysis/craving regulation aspects of CBT reduce cocaine self-administration in subjects with cocaine use disorder through diminished craving responses. Thirty non-treatment seeking human subjects meeting diagnostic criteria for cocaine use disorder will complete an outpatient, crossover, placebo-controlled study consisting of 1 practice and 9 experimental sessions. In each experimental session, the reinforcing effects of intranasal cocaine will be determined under one of three regulation of craving conditions that simulate CBT decisional analysis (i.e., negative instruction, positive instruction or a neutral "look" condition). After sampling the dose of cocaine available in each session, subjects will complete the craving manipulation assigned to that session, they will then rate their craving and finally they will have the opportunity to earn the sampled dose in a progressive-ratio procedure. We hypothesize that focusing on the negative effects of cocaine use will decrease craving and reduce cocaine self-administration relative to the positive and "look" conditions, and that craving will be positively correlated with self-administration outcomes.

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, Outcomes Assessor)

入排标准

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

入选标准

  • Current cocaine use

排除标准

  • Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
  • Current or past histories of substance use disorder that are deemed by the study physicians to interfere with study completion
  • History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
  • Females not currently using effective birth control
  • Contraindications to cocaine

研究组 & 干预措施

Neutral-Look

Sham Comparator

Subjects will be instructed to look at cocaine associated images and respond naturally.

干预措施: Craving Manipulation (Behavioral)

Neutral-Look

Sham Comparator

Subjects will be instructed to look at cocaine associated images and respond naturally.

干预措施: Cocaine (Drug)

Neutral-Look

Sham Comparator

Subjects will be instructed to look at cocaine associated images and respond naturally.

干预措施: Placebo (Drug)

Positive

Experimental

Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.

干预措施: Craving Manipulation (Behavioral)

Positive

Experimental

Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.

干预措施: Cocaine (Drug)

Positive

Experimental

Subjects will be instructed to look at cocaine associated images and anticipate the positive aspects of engaging with the items shown.

干预措施: Placebo (Drug)

Negative

Active Comparator

Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.

干预措施: Craving Manipulation (Behavioral)

Negative

Active Comparator

Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.

干预措施: Cocaine (Drug)

Negative

Active Comparator

Subjects will be instructed to look at cocaine associated images and anticipate the negative aspects of engaging with the items shown.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Times Cocaine Was Selected

时间窗: One test for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.

The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects can make 5 choices for each available cocaine dose. Reinforcing effects were measured for each cocaine dose during across the craving manipulation conditions.

次要结局

  • Cocaine Craving(Measured for each of the craving manipulations for placebo and each cocaine dose level over approximately two weeks of participation.)

研究者

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

William Stoops

Professor

University of Kentucky

研究点 (1)

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