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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by CAMC Health System
Sponsor:
Collaborators:
West Virginia University
University of Charleston
Information provided by (Responsible Party):
Crisitian Sirbu, PhD, CAMC Health System
ClinicalTrials.gov Identifier:
NCT01037101
First received: December 18, 2009
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention
Height Phobia
Behavioral: In Vivo Exposure Therapy
Behavioral: Virtual Reality Exposure Therapy
Drug: D-Cycloserine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: D-Cycloserine as Enhancer of One-Session Treatment for Phobia of Heights in Adults

Resource links provided by NLM:


Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • Specific Phobia (acrophobia) diagnosis based on Anxiety Disorders Interview Schedule-IV (ADIS-IV) [ Time Frame: One week post-treatment and 3 months folow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Seromycin
Experimental: VRET+DCS Behavioral: Virtual Reality Exposure Therapy
Three hours of exposure therapy using a virtual reality system
Drug: D-Cycloserine
50 mg of DCS administered 30 minutes before the session
Other Name: Seromycin
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037101

Locations
United States, West Virginia
West Virginia University School of Medicine Charleston Division Recruiting
Charleston, West Virginia, United States, 25304
Contact: Cristian Sirbu, Ph.D.    304-388-1024    cristian.sirbu@camc.org   
Contact: Patrick L Kerr, Ph.D.    304.388.1033    patrick.kerr@camc.org   
Sponsors and Collaborators
CAMC Health System
West Virginia University
University of Charleston
Investigators
Principal Investigator: Cristian Sirbu, Ph.D. CAMC Health System
  More Information

No publications provided

Responsible Party: Crisitian Sirbu, PhD, Research Scientist, CAMC Health System
ClinicalTrials.gov Identifier: NCT01037101     History of Changes
Other Study ID Numbers: 07-01-1896
Study First Received: December 18, 2009
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
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

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014