Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Phobic Disorders Clinical Trial

Official title:

Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734422
• Other study ID #: KP-2007-226
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2018
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Phobic Disorders

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University of Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of Anxiety Symptoms (Beck Anxiety Inventory) Anxiety Sensitivity (Anxiety Sensitivity Inventory)		Assessed at pre- and post-treatment and 9-12 months follow-up