Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

This study has been completed.
Sponsor:
Information provided by:
VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT00734422
First received: August 11, 2008
Last updated: August 3, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Phobic Disorders
Behavioral: Virtual Reality Exposure Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VRET with yohimbine
Virtual Reality Exposure Therapy will be combined with the administration of yohimbine hydrochloride
Behavioral: Virtual Reality Exposure Therapy
Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.
Placebo Comparator: VRET with placebo
Virtual Reality Exposure Therapy will be combined with an inactive placebo pill (Albochin).
Behavioral: Virtual Reality Exposure Therapy
Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734422

Locations
Netherlands
University of Amsterdam
Amsterdam, Netherlands
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Paul MG Emmelkamp, Professor University of Amsterdam, The Netherlands
  More Information

No publications provided

Responsible Party: Professor dr. Paul M.G. Emmelkamp, Department of Clinical Psychology, University of Amsterdam, The Netherlands
ClinicalTrials.gov Identifier: NCT00734422     History of Changes
Other Study ID Numbers: KP-2007-226
Study First Received: August 11, 2008
Last Updated: August 3, 2011
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by VU University of Amsterdam:
Phobic Disorders (Fear of Flying)
Virtual Reality Exposure Therapy
Fear extinction
Yohimbine

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Yohimbine
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014