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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01450306
First received: October 6, 2011
Last updated: March 25, 2016
Last verified: March 2016
  Purpose
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 Intervention
Specific Phobia
Drug: D-cycloserine
Behavioral: Exposure therapy
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Snake Questionnaire (SNAQ) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

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



Secondary Outcome Measures:
  • Clinician's Global Impression (CGI)-Severity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

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


  • Clinician's Global Impression (CGI)-Improvement [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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



Enrollment: 20
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 6, 2011
Results First Received: May 24, 2012
Last Updated: March 25, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
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

ClinicalTrials.gov processed this record on July 28, 2016