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临床试验/NCT05507814
NCT05507814已完成不适用

Test Reinforcer Pathology Via Manipulation of the Temporal Window With Successive Episodic Future Thinking Generation.

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2022年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
2
主要终点
Neural activation during fMRI delay discounting task

研究概览

简要总结

The primary objective is to test the theory of Reinforcer Pathology via manipulation of the temporal window with successive Episodic Future Thinking generation in individuals with cocaine use disorder.

详细描述

Adults with cocaine use disorder will be randomly assigned to experimental or control groups, stratified by polydrug use disorder, SES, and sex. The experimental group will compare episodic future thinking (EFT) to control episodic thinking (CET). The study procedures will include a baseline session (S1) and a 4-week intervention period where participants will return to the lab three times a week. Participants will generate new EFT and CET events at approximately weekly intervals. The EFT or CET events will be texted to them twice daily with urine samples obtained thrice-weekly. To probe resistance to disruption, both groups will receive stress-inducing probes that shorten the temporal window after the first and last cue generation. During the first assessment visit (S2), participants will be randomized with stratification to generate either episodic future thinking (EFT) or control episodic thinking (CET) events and will undergo neuroimaging procedures. At the following session in S3, participants will be randomized to receive one of two stress probes (counterbalanced) or their respective control. Participants will be exposed to a stress probe or control at S3 and the corresponding narrative at the next visit, S4. S5 and S6 will begin with participants generating new EFT/CET events that will be used for that session and the following two sessions. S7, like S2, will begin with EFT/CET event generation and neuroimaging procedures. During the final two sessions (S8, S9), participants will be exposed to the other stress probe and control that they did not see during S3/S4.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • demonstrate recent cocaine use and CUD (use in last month, DSM-5 for CUD > 4)
  • be 18 years of age or older
  • have a desire to quit or cut down on their cocaine use, but do not have proximate plans to enroll in treatment for CUD during the study period

排除标准

  • meeting moderate to severe DSM-5 criteria for opioid use disorder
  • having a current diagnosis of any psychotic disorder
  • having a history of seizure disorders or traumatic brain injury
  • having any contraindication for participation in the MRI sessions

结局指标

主要结局

Neural activation during fMRI delay discounting task

时间窗: Over four weeks of participation (Baseline, Week 1, Week 4)

Brain maps will be compared between groups and time points.

Change in Delay Discounting

时间窗: Over four-weeks of participation (Weekly for four weeks)

Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using adjusting amount delay discounting and minute delay discounting tasks. Change in discounting rates will be compared within-subjects across sessions and between groups.

Change in Cocaine Demand

时间窗: Over four weeks of participation (Weekly for four weeks)

Intensity and elasticity of cocaine demand will be determined from a cocaine demand curve via a Cocaine Purchase Task (CPT). Change in cocaine demand will be compared within-subjects across sessions and between groups.

Cocaine Craving

时间窗: Over four weeks of participation (Weekly for four weeks)

The Desires for Drug Questionnaire (DDQ) will be used to assess instant craving for cocaine. Change in cocaine craving will be compared within-subjects across sessions and between groups.

Neural activation during fMRI cocaine purchase task

时间窗: Over four weeks of participation (Baseline, Week 1, Week 4)

Brain maps will be compared between groups and time points.

次要结局

  • Daily Cocaine Use(Over four weeks of participation)
  • Cocaine Urinalysis(Over four weeks of participation)

研究者

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

Stephen LaConte

Professor

Virginia Polytechnic Institute and State University

研究点 (2)

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