Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-12-31

Brief Summary

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Recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. One cognitive enhancers is Yohimbine hydrochloride (YOH). A finding in animal literature is that the administration of YOH 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. However, recent findings demonstrate mixed results. In a randomized controlled trial claustrophobic participants underwent exposure in combination with YOH or placebo. The YOH group showed significantly better results on anxiety improvement than the placebo group. In a more recent study with participants with fear of flying no additional benefits of YOH were demonstrated. Therefore, we intend to replicate and extend these studies by enhancing the dose of YOH in combination with VRET and by extending our experimental design with another group which receives propranolol in combination with VRET. Propranolol is β-adrenergic receptor antagonist, which has proven to disrupt reconsolidation in healthy humans. In this randomized controlled trial a between groups design is chosen to further characterize the differential within and between trial extinction and to enhance possible between groups effects. Sixty participants with fear of flying or fear of heights will be randomly assigned to one of the following three conditions 1) VRET plus YOH, 2) VRET plus Propranolol, or 3) VRET plus placebo. Participants in all conditions will be offered three sessions of VRET over a period of two weeks.

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Detailed Description

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Conditions

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Phobic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VRET plus Yohimbine

Virtual Reality Exposure Therapy combined with the administration of yohimbine.

Group Type ACTIVE_COMPARATOR

Virtual Reality Exposure Therapy (VRET)

Intervention Type BEHAVIORAL

Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

VRET plus propranolol

Virtual Reality Exposure Therapy combined with the administration of propranolol

Group Type ACTIVE_COMPARATOR

Virtual Reality Exposure Therapy (VRET)

Intervention Type BEHAVIORAL

Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

VRET plus placebo

Virtual Reality Exposure Therapy combined with the administration of a non-active placebo pill

Group Type PLACEBO_COMPARATOR

Virtual Reality Exposure Therapy (VRET)

Intervention Type BEHAVIORAL

Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

Interventions

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Virtual Reality Exposure Therapy (VRET)

Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Marked fear of flying or acrophobia, indicated by a subjective fear rating of moderate or higher on anxiety specific measures.

Being older than 18 years and younger than 75 years.