Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants

NCT ID: NCT00734422

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VRET with yohimbine

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

Group Type: EXPERIMENTAL

Virtual Reality Exposure Therapy

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Virtual Reality Exposure Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: lead

Responsible Party

Paul M.G.Emmelkamp

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul MG Emmelkamp, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

Locations

University of Amsterdam

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

KP-2007-226

Identifier Type: -

Identifier Source: org_study_id