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Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics

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ClinicalTrials.gov Identifier: NCT01450306
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : April 21, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the present study is to determine whether people receiving d-cycloserine and exposure therapy show different brain reactions to symptom provocation compared to people receiving placebo and exposure therapy.

Condition or disease Intervention/treatment
Specific Phobia Drug: D-cycloserine Behavioral: Exposure therapy Drug: Placebo

Detailed Description:
D-cycloserine (DCS) is a partial N-methyl-D-aspartate (NMDA) receptor agonist that may improve or accelerate extinction learning. We will randomly assign people with snake phobia to receive DCS or placebo, and then provide all participants with exposure therapy. We will examine whether people receiving DCS and vs. placebo show different brain reactions to symptom provocation before and after exposure therapy.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
Study Start Date : July 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
Drug Information available for: Cycloserine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: D-cycloserine plus exposure therapy
Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
Drug: D-cycloserine
50 mg d-cycloserine, oral, 1 dose
Behavioral: Exposure therapy
Single session graded in vivo exposure therapy, 60-180 minutes
Placebo Comparator: Placebo plus exposure therapy
Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Behavioral: Exposure therapy
Single session graded in vivo exposure therapy, 60-180 minutes
Drug: Placebo
Single capsule of oral placebo, administered once 1 hr prior to exposure therapy


Outcome Measures

Primary Outcome Measures :
  1. Snake Questionnaire (SNAQ) [ Time Frame: 2 weeks ]

    30-item self-report scale of severity of snake fear and avoidance

    Range: 0-30; higher values indicate greater fear severity



Secondary Outcome Measures :
  1. Clinician's Global Impression (CGI)-Severity [ Time Frame: 2 weeks ]

    Clinician rating of global illness severity (at pre- and post-treatment)

    CGI-Severity range 1-7; higher scores indicate greater illness severity.


  2. Clinician's Global Impression (CGI)-Improvement [ Time Frame: 2 weeks ]

    Clinician rating of global illness severity (at post-treatment)

    CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of specific phobia (snakes)

Exclusion Criteria:

  • History of psychosis, obsessive-compulsive disorder, or mania
  • Recent substance abuse or suicidality
  • Previous receipt of study treatments
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450306


Locations
United States, Connecticut
Institute of Living/Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: David Tolin, PhD Hartford Hospital
More Information

Publications:
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01450306     History of Changes
Other Study ID Numbers: NAVE003220HU
First Posted: October 12, 2011    Key Record Dates
Results First Posted: April 21, 2016
Last Update Posted: April 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available upon request

Additional relevant MeSH terms:
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action