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临床试验/NCT00734422
NCT00734422已完成2 期

Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

VU University of Amsterdam1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2008年7月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
Flight Anxiety Situations Questionnaire (self-report); Flight Anxiety Modality Questionnaire (self-report)

研究概览

简要总结

Procedurally Virtual reality exposure therapy (VRET) is quite similar to models of extinction of conditioned fears. Recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. One of these cognitive enhancers is Yohimbine. An interesting finding in animal literature is that the administration of Yohimbine during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. It is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine in the prefrontal cortex. Therefore, we propose to extend these studies by combining VRET with Yohimbine. In this pilot study with a between groups design 20 participants with a fear of flying will be treated with VRET plus Yohimbine or VRET plus placebo. This between groups design was chosen to further characterize the differential within and between trial extinction. Outcome will be measured by self-report, behavioral, and psychophysiological assessments at pre- and post-treatment. In addition, we will examine extinction parameters during exposures.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of specific phobia (fear of flying).
  • Between the ages of 18-65
  • Sufficient fluency in Dutch to complete treatment and research protocol

排除标准

  • Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, respiratory disorder, cardiovascular disease, pacemaker, hypertension).
  • Resting blood pressure higher than 140 (systolic) or 105 (diastolic)
  • Unstable psychotropic medication.
  • Current use of tranquilizers (Benzodiazepines)
  • Psychosis
  • Depression with suicidal ideation
  • Dementia or other severe cognitive impairment
  • Substance dependence
  • Bipolar disorder
  • Borderline personality disorder
  • Anti-social personality disorder
  • Current use of beta-blockers

结局指标

主要结局

Flight Anxiety Situations Questionnaire (self-report); Flight Anxiety Modality Questionnaire (self-report)

时间窗: Assessed at pre- and post-treatment and 9-12 months follow-up

次要结局

  • Severity of Anxiety Symptoms (Beck Anxiety Inventory) Anxiety Sensitivity (Anxiety Sensitivity Inventory)(Assessed at pre- and post-treatment and 9-12 months follow-up)

研究者

发起方
VU University of Amsterdam
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul M.G.Emmelkamp

Professor

VU University of Amsterdam

研究点 (1)

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