D-Cycloserine-Enhancer of One-Session Treatment for Phobia of Heights
This study is currently recruiting participants.
Verified March 2012 by CAMC Health System
Sponsor:
CAMC Health System
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: March 5, 2012
Last verified: March 2012
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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 2012 |
| Estimated Primary Completion Date: | September 2012 (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
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: | March 5, 2012 |
| 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-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013