Phobic DisordersPhase 2/3NCT00734422
Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants
A Phase 2/3 study testing Virtual Reality Exposure Therapy in people with Phobic Disorders, run by VU University of Amsterdam at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- Virtual Reality Exposure Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Dementia or other severe cognitive impairment
- Substance dependence
- Bipolar disorder
- Borderline personality disorder
- Anti-social personality disorder
- Current use of beta-blockers
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Virtual Reality Exposure Therapy
- Keywords
- Phobic Disorders (Fear of Flying), Virtual Reality Exposure Therapy, Fear extinction, Yohimbine
- Medical subject headings
- Phobic Disorders, Aerophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure TherapyBehavioural
Standard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill.
| Study group | Role | What they receive |
|---|---|---|
| VRET with yohimbine | Experimental | Virtual Reality Exposure Therapy will be combined with the administration of yohimbine hydrochloride Receives: Behavioral: Virtual Reality Exposure Therapy |
| VRET with placebo | Placebo comparator | Virtual Reality Exposure Therapy will be combined with an inactive placebo pill (Albochin). Receives: Behavioral: Virtual Reality Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flight Anxiety Situations Questionnaire (self-report); Flight Anxiety Modality Questionnaire (self-report)
Measured: 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)
Measured: Assessed at pre- and post-treatment and 9-12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M.G.Emmelkamp, VU University of Amsterdam
- Investigators
- Paul MG Emmelkamp, Professor, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734422
- Sponsor's protocol ID
- KP-2007-226
- Status last verified
- Sep 2018
- First submitted
- 11 Aug 2008
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitation of Fear Extinction With Yohimbine Hydrochloride in Phobic Participants
- ClinicalTrials.gov ID
- NCT00734422
- Acronym / sponsor ID
- KP-2007-226
- Conditions
- Phobic Disorders
- Keywords
- Phobic Disorders (Fear of Flying), Virtual Reality Exposure Therapy, Fear extinction, Yohimbine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRET with yohimbine | Experimental | Behavioral: Virtual Reality Exposure TherapyVirtual Reality Exposure Therapy will be combined with the administration of yohimbine hydrochloride |
| VRET with placebo | Placebo comparator | Behavioral: Virtual Reality Exposure TherapyVirtual Reality Exposure Therapy will be combined with an inactive placebo pill (Albochin). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Exposure TherapyStandard virtual reality exposure therapy for fear of flying will be combined with the administration of either yohimbine hydrochloride or an inactive placebo pill. | Behavioural | VRET with placebo, VRET with yohimbine |
Primary outcome
Flight Anxiety Situations Questionnaire (self-report); Flight Anxiety Modality Questionnaire (self-report)
Time frame: Assessed at pre- and post-treatment and 9-12 months follow-up
1 secondary outcome
Severity of Anxiety Symptoms (Beck Anxiety Inventory) Anxiety Sensitivity (Anxiety Sensitivity Inventory)
Time frame: Assessed at pre- and post-treatment and 9-12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
Related trials for Phobic Disorders
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Recruiting
Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement
Phobia
Recruiting
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
Recruiting
Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting
Emotional Disorders, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Not yet recruiting
A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
Specific Phobia, Animal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul MG Emmelkamp, Professor principal investigator
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Virtual Reality Exposure Therapy in people with Phobic Disorders, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flight Anxiety Situations Questionnaire (self-report); Flight Anxiety Modality Questionnaire (self-report) (time frame: Assessed at pre- and post-treatment and 9-12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.