Clinical trial NCT01037101: D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
Official title: D-Cycloserine as Enhancer of One-Session Treatment for Phobia of Heights in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: CAMC Health System
Sponsor class: OTHER
Collaborators: name: West Virginia University
name: University of Charleston
First posted: 2009-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Specific Phobia (acrophobia) diagnosis based on Anxiety Disorders Interview Schedule-IV (ADIS-IV)
timeFrame: One week post-treatment and 3 months folow-up
Secondary outcomes:
measure: Physiological responses to phobia-related stimuli, percentage of steps completed and Subjective Units of Distress during a Behavioral Avoidance Test (BAT)
timeFrame: One week post-treatment and 3 months follow-up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: West Virginia University School of Medicine Charleston Division
state: West Virginia
Study officials:
affiliation: CAMC Health System
name: Cristian Sirbu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: