Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

September 11, 2018 updated by: Paul M.G.Emmelkamp, VU University of Amsterdam
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • University of Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at pre- and post-treatment and 9-12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Assessed at pre- and post-treatment and 9-12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VU University of Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP-2007-226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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