Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Sponsor

VU University of Amsterdam (Other)

Overall Status

Completed

CT.gov ID

NCT00734422

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Phobic Disorders	Behavioral: Virtual Reality Exposure Therapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Flight Anxiety Situations Questionnaire (self-report); Flight Anxiety Modality Questionnaire (self-report) [Assessed at pre- and post-treatment and 9-12 months follow-up]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Amsterdam	Amsterdam		Netherlands

Sponsors and Collaborators

VU University of Amsterdam

Investigators

Principal Investigator: Paul MG Emmelkamp, Professor, University of Amsterdam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paul M.G.Emmelkamp, Professor, VU University of Amsterdam

ClinicalTrials.gov Identifier:

NCT00734422

Other Study ID Numbers:

KP-2007-226

First Posted:

Aug 14, 2008

Last Update Posted:

Sep 13, 2018

Last Verified:

Sep 1, 2018

Keywords provided by Paul M.G.Emmelkamp, Professor, VU University of Amsterdam

Phobic Disorders (Fear of Flying)

Virtual Reality Exposure Therapy

Fear extinction

Yohimbine

Additional relevant MeSH terms:

Phobic Disorders

Study Results

No Results Posted as of Sep 13, 2018