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

NCT01037101 | Unknown

• 1 other identifier: 07-01-1896
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Specific Phobia (acrophobia) diagnosis based on Anxiety Disorders Interview Schedule-IV (ADIS-IV)

  One week post-treatment and 3 months folow-up

Secondary Outcomes (1)

• Physiological responses to phobia-related stimuli, percentage of steps completed and Subjective Units of Distress during a Behavioral Avoidance Test (BAT)

  One week post-treatment and 3 months follow-up

Study Arms (5)

IVET+DCS

ACTIVE COMPARATOR

Behavioral: In Vivo Exposure Therapy; Drug: D-Cycloserine

VRET+DCS

EXPERIMENTAL

Behavioral: Virtual Reality Exposure Therapy; Drug: D-Cycloserine

VRET+Placebo

EXPERIMENTAL

Behavioral: Virtual Reality Exposure Therapy; Drug: Placebo

IVET+Placebo

ACTIVE COMPARATOR

Behavioral: In Vivo Exposure Therapy; Drug: Placebo

Wait-List

NO INTERVENTION

3 weeks Wait-List

Interventions

In Vivo Exposure Therapy BEHAVIORAL

Three hours of exposure therapy in a high place

IVET+DCS; IVET+Placebo

Virtual Reality Exposure Therapy BEHAVIORAL

Three hours of exposure therapy using a virtual reality system

VRET+DCS; VRET+Placebo

D-Cycloserine DRUG

50 mg of DCS administered 30 minutes before the session

Also known as: Seromycin

IVET+DCS; VRET+DCS

Placebo DRUG

50 mg placebo administered 30 minutes before the session

IVET+Placebo; VRET+Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead
• West Virginia University: collaborator
• University of Charleston: collaborator

Study Sites (1)

West Virginia University School of Medicine Charleston Division

Charleston, West Virginia, 25304, United States

RECRUITING

MeSH Terms

Conditions

Acrophobia

Interventions

Virtual Reality Exposure Therapy; Cycloserine

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Cristian Sirbu, Ph.D.

  CAMC Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

US (1)