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临床试验/NCT02444208
NCT02444208已完成不适用

Randomized Clinical Trial (01): A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use

University of Kentucky2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Stop-Signal Task

研究概览

简要总结

Cocaine abuse is an unrelenting public-health concern. Behavioral therapies are considered the "standard of care" for reducing cocaine use and preventing relapse. However, even with intense behavioral interventions, rates of relapse to cocaine use are discouragingly high (i.e., 60-95% of patients return to drug use). Novel strategies are urgently needed to improve treatment outcomes for cocaine-use disorders. The overarching goal of this project is to assess the feasibility, acceptability and initial efficacy of an innovative cocaine-based inhibitory-control training procedure. This goal will be accomplished through the conduct of a Stage I pilot trial. Cocaine-dependent participants will be enrolled and randomized to receive inhibitory-control training to cocaine or neutral images (N=20/condition). This proposed intervention, cocaine based inhibitory-control training, will be delivered using an innovative computer program which teaches cocaine abusers to inhibit a pre-potent response to cocaine or neutral cues. The primary hypothesis is the proposed procedures are feasible and acceptable to the participants. Feasibility will be assessed by determining time needed to enroll the target sample; adaptive randomization outcomes; participant attendance, completion and adherence to study procedures. Acceptability will be determined using a Treatment Acceptability Questionnaire. The secondary hypothesis is that participants receiving cocaine-based inhibitory-control training will reduce their drug use to a greater extent than their counterparts in the neutral-image condition. Reduced cocaine use will be demonstrated by fewer positive-urine samples using qualitative urinalysis and a reduction in levels of benzoylecgonine as determined by quantitative urinalysis (i.e., ELISA). The third hypothesis is that participants receiving cocaine-based inhibitory-control training will show improved inhibitory control and neurocognitive functioning relative to their counterparts in the neutral-image condition. Improved inhibitory control, impulsivity and cognitive functioning will be demonstrated using a battery of clinical instruments and laboratory tasks. The proposed research is highly innovative in that it will provide critical information regarding the feasibility, acceptability, initial efficacy of cocaine-based inhibitory-control training to reduce drug use and improve inhibitory control and neurocognitive functioning in cocaine-dependent participants. Cocaine-based inhibitory control training is also easy to administer (i.e., 15 minutes), inexpensive, need not be administered by a clinician, and could easily be incorporated into current behavioral or community-based treatment approaches to enhance sustained abstinence, thereby quickly impacting clinical research and practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, 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

  • Recent cocaine use verified by a cocaine-positive urine sample
  • Meet Cocaine Abuse or Dependence criteria, verified by computerized Structured Clinical Interview for DSM-IV (SCID)
  • Subjects must be seeking treatment for their cocaine use.
  • Subjects must have at least 10% errors in response to cocaine go cues on the ABBA Task at baseline

排除标准

  • History of serious physical or psychiatric disease that would interfere with study participation
  • Current physical or psychiatric disease that would interfere with study participation
  • Current or past histories of substance abuse or dependence that would interfere with study completion

研究组 & 干预措施

Cocaine Inhibitory Control Training

Experimental

This group will receive active inhibitory control training.

干预措施: Active Inhibitory Control Training (Behavioral)

Neutral Inhibitory Control Training

Placebo Comparator

This group will receive neutral inhibitory control training.

干预措施: Neutral Inhibitory Control Training (Behavioral)

结局指标

主要结局

Stop-Signal Task

时间窗: 8 weeks after study entry

Response inhibition and response execution will be measured using a stop-signal paradigm using a choice reaction time task that engages participants in responding to go-signals when stop-signals occasionally inform them to inhibit the response.

次要结局

  • Self-Reported Cocaine Use(7 days)
  • Retention(8, 9 and 10 weeks after study entry)
  • Protocol Adherence(Three years)
  • Biologically verified cocaine use(72 hours)
  • Recruitment(Three years)
  • Treatment acceptability(8, 9 and 10 weeks after study)

研究者

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

Craig Rush

Professor

University of Kentucky

研究点 (2)

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