Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

NCT00734422 | Completed Phase 2

• 1 other identifier: KP-2007-226
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobic Disorders

Keywords

Phobic Disorders (Fear of Flying); Virtual Reality Exposure Therapy; Fear extinction; Yohimbine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Severity of Anxiety Symptoms (Beck Anxiety Inventory) Anxiety Sensitivity (Anxiety Sensitivity Inventory)

  Assessed at pre- and post-treatment and 9-12 months follow-up

Study Arms (2)

VRET with yohimbine

EXPERIMENTAL

Virtual Reality Exposure Therapy will be combined with the administration of yohimbine hydrochloride

Behavioral: Virtual Reality Exposure Therapy

VRET with placebo

PLACEBO COMPARATOR

Virtual Reality Exposure Therapy will be combined with an inactive placebo pill (Albochin).

Behavioral: Virtual Reality Exposure Therapy

Interventions

Virtual Reality Exposure Therapy BEHAVIORAL

Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.

VRET with placebo; VRET with yohimbine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

University of Amsterdam

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Phobic Disorders; Aerophobia

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paul MG Emmelkamp, Professor

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 14, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2010
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

NL (1)