Noradrenergic Manipulation and Virtual Reality Exposure Therapy in Phobic Participants

VU University of Amsterdam

Status and phase: Completed; Phase 3; Phase 2

Conditions: Phobic Disorders

Treatments: Behavioral: Virtual Reality Exposure Therapy (VRET)

Study type: Interventional

Funder types: Other

Identifiers

NCT02007694

2012-KP-2464

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

VRET plus Yohimbine

Active Comparator group

Description:

Virtual Reality Exposure Therapy combined with the administration of yohimbine.

Treatment:

Behavioral: Virtual Reality Exposure Therapy (VRET)

VRET plus propranolol

Active Comparator group

Description:

Virtual Reality Exposure Therapy combined with the administration of propranolol

Treatment:

Behavioral: Virtual Reality Exposure Therapy (VRET)

VRET plus placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Virtual Reality Exposure Therapy (VRET)