Recruiting

D-Cycloserine

Sponsor:

CAMC Health System

Code:

NCT01037101

Conditions

Height Phobia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

In Vivo Exposure Therapy

Virtual Reality Exposure Therapy

D-Cycloserine

Placebo

Study Details

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).

Conditions

Height Phobia

Study ID

NCT01037101

Start date

Jul, 2009

Status verified date

Oct, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: IVET+DCS

experimental: VRET+DCS

experimental: VRET+Placebo

active comparator: IVET+Placebo

no intervention: Wait-List

3 weeks Wait-List

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Locations

West Virginia University School of Medicine Charleston Division

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Cristian Sirbu, Ph.D.

304-388-1024cristian.sirbu@camc.org

Patrick L Kerr, Ph.D.

304.388.1033patrick.kerr@camc.org

More Information

Sponsor

CAMC Health System

Last update posted

Oct 14, 2013

Last verified

Oct, 2013

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAMC Health System on 2013-10-14.