D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
NCT ID: NCT01037101
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2009-07-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IVET+DCS
In Vivo Exposure Therapy
Three hours of exposure therapy in a high place
D-Cycloserine
50 mg of DCS administered 30 minutes before the session
VRET+DCS
Virtual Reality Exposure Therapy
Three hours of exposure therapy using a virtual reality system
D-Cycloserine
50 mg of DCS administered 30 minutes before the session
VRET+Placebo
Virtual Reality Exposure Therapy
Three hours of exposure therapy using a virtual reality system
Placebo
50 mg placebo administered 30 minutes before the session
IVET+Placebo
In Vivo Exposure Therapy
Three hours of exposure therapy in a high place
Placebo
50 mg placebo administered 30 minutes before the session
Wait-List
3 weeks Wait-List
No interventions assigned to this group
Interventions
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In Vivo Exposure Therapy
Three hours of exposure therapy in a high place
Virtual Reality Exposure Therapy
Three hours of exposure therapy using a virtual reality system
D-Cycloserine
50 mg of DCS administered 30 minutes before the session
Placebo
50 mg placebo administered 30 minutes before the session
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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West Virginia University
OTHER
University of Charleston
OTHER
CAMC Health System
OTHER
Responsible Party
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Crisitian Sirbu, PhD
Research Scientist
Principal Investigators
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Cristian Sirbu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
CAMC Health System
Locations
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West Virginia University School of Medicine Charleston Division
Charleston, West Virginia, United States
Countries
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Facility Contacts
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Cristian Sirbu, Ph.D.
Role: primary
Patrick L Kerr, Ph.D.
Role: backup
Other Identifiers
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07-01-1896
Identifier Type: -
Identifier Source: org_study_id