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

NCT ID: NCT01037101

Last Updated: 2013-10-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Height Phobia

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IVET+DCS

Group Type ACTIVE_COMPARATOR

In Vivo Exposure Therapy

Intervention Type BEHAVIORAL

Three hours of exposure therapy in a high place

D-Cycloserine

Intervention Type DRUG

50 mg of DCS administered 30 minutes before the session

VRET+DCS

Group Type EXPERIMENTAL

Virtual Reality Exposure Therapy

Intervention Type BEHAVIORAL

Three hours of exposure therapy using a virtual reality system

D-Cycloserine

Intervention Type DRUG

50 mg of DCS administered 30 minutes before the session

VRET+Placebo

Group Type EXPERIMENTAL

Virtual Reality Exposure Therapy

Intervention Type BEHAVIORAL

Three hours of exposure therapy using a virtual reality system

Placebo

Intervention Type DRUG

50 mg placebo administered 30 minutes before the session

IVET+Placebo

Group Type ACTIVE_COMPARATOR

In Vivo Exposure Therapy

Intervention Type BEHAVIORAL

Three hours of exposure therapy in a high place

Placebo

Intervention Type DRUG

50 mg placebo administered 30 minutes before the session

Wait-List

3 weeks Wait-List

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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In Vivo Exposure Therapy

Three hours of exposure therapy in a high place

Intervention Type BEHAVIORAL

Virtual Reality Exposure Therapy

Three hours of exposure therapy using a virtual reality system

Intervention Type BEHAVIORAL

D-Cycloserine

50 mg of DCS administered 30 minutes before the session

Intervention Type DRUG

Placebo

50 mg placebo administered 30 minutes before the session

Intervention Type DRUG

Other Intervention Names

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Seromycin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West Virginia University

OTHER

Sponsor Role collaborator

University of Charleston

OTHER

Sponsor Role collaborator

CAMC Health System

OTHER

Sponsor Role lead

Responsible Party

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Crisitian Sirbu, PhD

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

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