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Status unknownNCT01037101Updated Oct 14, 2013

D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights

An interventional study of In Vivo Exposure Therapy and Virtual Reality Exposure Therapy in Height Phobia, sponsored by CAMC Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-14.

Sponsored by CAMC Health System · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study will determine the effects of D-Cycloserine (DCS) on fear reduction in patients diagnosed with phobia of heights (acrophobia) undergoing one session of three hours of virtual reality exposure therapy (VRET) or in vivo exposure therapy (IVET).

Read the detailed description

The impact of D-Cycloserine on Virtual Reality Exposure Therapy (VRET) and In Vivo Exposure Therapy (IVET) for phobia of heights (acrophobia) will be tested using a randomized, double-blind, placebo-controlled trial. Eighty participants will be randomly assigned to one of the four treatment conditions: one-session VRET (3 hours) and 50 mg D-Cycloserine (VR-OST + DCS, N1=20); one-session VRET (3 hours) and placebo (VR-OST + Pl, N2=20); one-session IVET (3 hours) and placebo (IV + Pl, N3=20); or one-session IVET (3 hours) and 50 mg D-Cycloserine, (IV + DCS, N4=20). For twenty participants (5 from each group) the treatment will be delayed for three weeks and an additional assessment will be conducted as they will comprise a Wait List (WL) control group. Behavioral, cognitive and physiological changes in acrophobia will be assessed at pre-treatment, post-waitlist, post-treatment and 3 months follow-up.

02

Conditions studied

  • Height Phobia

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Keywords

  • acrophobia
  • virtual reality
  • exposure therapy
  • In Vivo Exposure Therapy plus D-Cycloserine
  • In Vivo Exposure Therapy plus Placebo
  • Virtual Reality Exposure Therapy plus D-Cycloserine
  • Virtual Reality Exposure Therapy plus Placebo
  • Wait-List
03

In context

Phobic Disorders

135 studies on the registry are indexed under Phobic Disorders; 16 are open to participants now.

This study's planned enrollment of 80 is above the median of 68 across 122 interventional studies indexed under Phobic Disorders.

Browse Phobic Disorders studies →

Lead sponsor

CAMC Health System is the lead sponsor of 47 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 18 and 65 years
  • Men and women
  • Diagnosis of acrophobia based on a clinical interview (ADIS-IV)
  • Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion criteria

Exclusion Criteria:

  • A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders; organic brain syndrome, cognitive dysfunction that could interfere with capacity to engage in therapy;
  • A history of substance or alcohol dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the period of study participation.
  • Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate services.
  • Patients must be off concurrent anxiolytics and beta blockers and on a stable dose of antidepressant medication for at least 3 weeks prior to initiation of randomized treatment.
  • Patients receiving medication that might interfere with study medication (medication that might lower seizure threshold: meperidine or antibiotics in high dosage: penicillins, cephalosporins, amphotericin and imipenem),
  • Patients with a current or past history of seizures
  • Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted effective methods of contraception or abstinence
  • Patients with a history of renal insufficiency (creatinine clearance less than 60 mL/min) or liver insufficiency
  • Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration specifically targeting phobias
  • Patients unable to understand study procedures and participate in the informed consent process.
  • Other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or blood-related diseases),
  • Inability to tolerate wearing the Virtual Reality Head Mounted Display,
  • If patients refuse the study medication
  • Any allergic reactions to D-Cycloserine by history
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    IVET+DCS

    Behavioral: In Vivo Exposure Therapy · Drug: D-Cycloserine

  • Experimental
    VRET+DCS

    Behavioral: Virtual Reality Exposure Therapy · Drug: D-Cycloserine

  • Experimental
    VRET+Placebo

    Behavioral: Virtual Reality Exposure Therapy · Drug: Placebo

  • Active comparator
    IVET+Placebo

    Behavioral: In Vivo Exposure Therapy · Drug: Placebo

  • No intervention
    Wait-List

    3 weeks Wait-List

Interventions

  • BehavioralIn Vivo Exposure Therapy

    Three hours of exposure therapy in a high place

  • BehavioralVirtual Reality Exposure Therapy

    Three hours of exposure therapy using a virtual reality system

  • DrugD-Cycloserine

    50 mg of DCS administered 30 minutes before the session

    Also known as: Seromycin

  • DrugPlacebo

    50 mg placebo administered 30 minutes before the session

06

What researchers measure

Primary outcomes

  1. Specific Phobia (acrophobia) diagnosis based on Anxiety Disorders Interview Schedule-IV (ADIS-IV)

    Time frame: One week post-treatment and 3 months folow-up

Secondary outcomes

  1. Physiological responses to phobia-related stimuli, percentage of steps completed and Subjective Units of Distress during a Behavioral Avoidance Test (BAT)

    Time frame: One week post-treatment and 3 months follow-up

07

Study locations

1 of 1 sites recruiting
  • West Virginia University School of Medicine Charleston Division
    Charleston, West Virginia 25304, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01037101
Lead sponsor
CAMC Health System
Collaborators
West Virginia University, University of Charleston
Responsible party
Crisitian Sirbu, PhD (Research Scientist, CAMC Health System) — Principal investigator
First posted
Dec 21, 2009
Start date
Jul 2009
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Oct 14, 2013

Study contacts

Cristian Sirbu, Ph.D.
principal investigator · CAMC Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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