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

Primary Purpose

Height Phobia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In Vivo Exposure Therapy
Virtual Reality Exposure Therapy
D-Cycloserine
Placebo
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Height Phobia focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • West Virginia University School of Medicine Charleston DivisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Active Comparator

No Intervention

Arm Label

IVET+DCS

VRET+DCS

VRET+Placebo

IVET+Placebo

Wait-List

Arm Description

3 weeks Wait-List

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2009
Last Updated
October 11, 2013
Sponsor
CAMC Health System
Collaborators
West Virginia University, University of Charleston
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1. Study Identification

Unique Protocol Identification Number
NCT01037101
Brief Title
D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
Official Title
D-Cycloserine as Enhancer of One-Session Treatment for Phobia of Heights in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CAMC Health System
Collaborators
West Virginia University, University of Charleston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Height Phobia
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVET+DCS
Arm Type
Active Comparator
Arm Title
VRET+DCS
Arm Type
Experimental
Arm Title
VRET+Placebo
Arm Type
Experimental
Arm Title
IVET+Placebo
Arm Type
Active Comparator
Arm Title
Wait-List
Arm Type
No Intervention
Arm Description
3 weeks Wait-List
Intervention Type
Behavioral
Intervention Name(s)
In Vivo Exposure Therapy
Intervention Description
Three hours of exposure therapy in a high place
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
Three hours of exposure therapy using a virtual reality system
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Other Intervention Name(s)
Seromycin
Intervention Description
50 mg of DCS administered 30 minutes before the session
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 mg placebo administered 30 minutes before the session
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian Sirbu, Ph.D.
Organizational Affiliation
CAMC Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University School of Medicine Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristian Sirbu, Ph.D.
Phone
304-388-1024
Email
cristian.sirbu@camc.org
First Name & Middle Initial & Last Name & Degree
Patrick L Kerr, Ph.D.
Phone
304.388.1033
Email
patrick.kerr@camc.org

12. IPD Sharing Statement

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

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