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Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Primary Purpose

Phobic Disorders

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phobic Disorders focused on measuring Phobic Disorders (Fear of Flying), Virtual Reality Exposure Therapy, Fear extinction, Yohimbine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VRET with yohimbine

VRET with placebo

Arm Description

Virtual Reality Exposure Therapy will be combined with the administration of yohimbine hydrochloride

Virtual Reality Exposure Therapy will be combined with an inactive placebo pill (Albochin).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2008
Last Updated
September 11, 2018
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT00734422
Brief Title
Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants
Official Title
Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobic Disorders
Keywords
Phobic Disorders (Fear of Flying), Virtual Reality Exposure Therapy, Fear extinction, Yohimbine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VRET with yohimbine
Arm Type
Experimental
Arm Description
Virtual Reality Exposure Therapy will be combined with the administration of yohimbine hydrochloride
Arm Title
VRET with placebo
Arm Type
Placebo Comparator
Arm Description
Virtual Reality Exposure Therapy will be combined with an inactive placebo pill (Albochin).
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul MG Emmelkamp, Professor
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Amsterdam
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

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Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

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