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Completed

NCT Number: NCT00734422

Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Amsterdam

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

virtual reality exposure therapy

Behavioral

Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.

Primary outcomes

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

    Time frame: Assessed at pre- and post-treatment and 9-12 months follow-up

Secondary outcomes

  1. Severity of Anxiety Symptoms (Beck Anxiety Inventory) Anxiety Sensitivity (Anxiety Sensitivity Inventory)

    Time frame: Assessed at pre- and post-treatment and 9-12 months follow-up

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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