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

October 11, 2013 updated by: Crisitian Sirbu, PhD, CAMC Health System

D-Cycloserine as Enhancer of One-Session Treatment for Phobia of Heights in Adults

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University School of Medicine Charleston Division
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IVET+DCS
Behavioral: In Vivo Exposure Therapy
Three hours of exposure therapy in a high place
Drug: D-Cycloserine
50 mg of DCS administered 30 minutes before the session
Other Names:
  • Seromycin
Experimental: VRET+DCS
Drug: D-Cycloserine
50 mg of DCS administered 30 minutes before the session
Other Names:
  • Seromycin
Behavioral: Virtual Reality Exposure Therapy
Three hours of exposure therapy using a virtual reality system
Experimental: VRET+Placebo
Behavioral: Virtual Reality Exposure Therapy
Three hours of exposure therapy using a virtual reality system
Drug: Placebo
50 mg placebo administered 30 minutes before the session
Active Comparator: IVET+Placebo
Behavioral: In Vivo Exposure Therapy
Three hours of exposure therapy in a high place
Drug: Placebo
50 mg placebo administered 30 minutes before the session
No Intervention: Wait-List
3 weeks Wait-List

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specific Phobia (acrophobia) diagnosis based on Anxiety Disorders Interview Schedule-IV (ADIS-IV)
Time Frame: One week post-treatment and 3 months folow-up
One week post-treatment and 3 months folow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
One week post-treatment and 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CAMC Health System

Collaborators

West Virginia University
University of Charleston

Investigators

  • Principal Investigator: Cristian Sirbu, Ph.D., CAMC Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 18, 2009

First Submitted That Met QC Criteria

December 18, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 11, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-01-1896

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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