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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

December 18, 2009
October 11, 2013
July 2009
December 2014   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01037101 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Height Phobia
  • Behavioral: In Vivo Exposure Therapy
    Three hours of exposure therapy in a high place
  • 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
  • Drug: Placebo
    50 mg placebo administered 30 minutes before the session
  • Active Comparator: IVET+DCS
    Interventions:
    • Behavioral: In Vivo Exposure Therapy
    • Drug: D-Cycloserine
  • Experimental: VRET+DCS
    Interventions:
    • Behavioral: Virtual Reality Exposure Therapy
    • Drug: D-Cycloserine
  • Experimental: VRET+Placebo
    Interventions:
    • Behavioral: Virtual Reality Exposure Therapy
    • Drug: Placebo
  • Active Comparator: IVET+Placebo
    Interventions:
    • Behavioral: In Vivo Exposure Therapy
    • Drug: Placebo
  • No Intervention: Wait-List
    3 weeks Wait-List
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
United States
 
NCT01037101
07-01-1896
No
Crisitian Sirbu, PhD, CAMC Health System
CAMC Health System
  • West Virginia University
  • University of Charleston
Principal Investigator: Cristian Sirbu, Ph.D. CAMC Health System
CAMC Health System
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP