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

NCT01450306 | Completed Results DMC

• 1 other identifier: NAVE003220HU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Specific Phobia

Outcome Measures

Primary Outcomes (1)

• Snake Questionnaire (SNAQ)

  30-item self-report scale of severity of snake fear and avoidance Range: 0-30; higher values indicate greater fear severity

  2 weeks

Secondary Outcomes (2)

• Clinician's Global Impression (CGI)-Severity

  2 weeks

• Clinician's Global Impression (CGI)-Improvement

  2 weeks

Study Arms (2)

D-cycloserine plus exposure therapy

EXPERIMENTAL

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; Behavioral: Exposure therapy

Placebo plus exposure therapy

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

D-cycloserine DRUG

50 mg d-cycloserine, oral, 1 dose

D-cycloserine plus exposure therapy

Exposure therapy BEHAVIORAL

Single session graded in vivo exposure therapy, 60-180 minutes

D-cycloserine plus exposure therapy; Placebo plus exposure therapy

Placebo DRUG

Single capsule of oral placebo, administered once 1 hr prior to exposure therapy

Placebo plus exposure therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of specific phobia (snakes)

You may not qualify if:

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• Nave AM, Tolin DF, Stevens MC. Exposure therapy, D-cycloserine, and functional magnetic resonance imaging in patients with snake phobia: a randomized pilot study. J Clin Psychiatry. 2012 Sep;73(9):1179-86. doi: 10.4088/JCP.11m07564.

  PMID: 23059145 RESULT

MeSH Terms

Conditions

Phobia, Specific

Interventions

Cycloserine; Implosive Therapy

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr David Tolin
• Organization: Hartford Hospital

david.tolin@hhchealth.org

860-545-7685

Study Officials

• David Tolin, PhD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 12, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 15, 2024
• Results First Posted: April 21, 2016

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)