Exposure, D-cycloserine Enhancement, and fMRI in Snake Phobics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hartford Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01450306
First received: October 6, 2011
Last updated: October 11, 2011
Last verified: October 2011
  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 fMRI in Snake Phobics

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Change in blood oxygen level dependent (BOLD) signal in several brain regions of interest [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Brain response to symptom provocation (viewing photographs of snakes) will be measured using functional magnetic resonance imaging (fMRI) at pre- and post-treatment.


Secondary Outcome Measures:
  • Snake Questionnaire (SNAQ) [Klorman R, Weerts TC, Hastings JE, Melamed BG, Lang PJ. Psychometric description of some specific fear questionnaires. Behavior Therapy. 1974;5:401-409.] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    30-item self-report scale of severity of snake fear and avoidance

  • Clinician's Global Impression (CGI) [Guy W. Assessment manual for psychopharmacology. Washington, DC: U.S. Government Printing Office; 1976.] [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Clinician rating of global illness severity (at pre- and post-treatment) and clinical improvement (at post-treatment).


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-cycloserine plus exposure therapy 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 Behavioral: Exposure therapy
Single session graded in vivo exposure therapy, 60-180 minutes
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
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
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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

No publications provided by Hartford Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01450306     History of Changes
Other Study ID Numbers: NAVE003220HU
Study First Received: October 6, 2011
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
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 September 22, 2014