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

NCT ID: NCT01450306

Last Updated: 2024-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Specific Phobia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

D-cycloserine

Intervention Type DRUG

50 mg d-cycloserine, oral, 1 dose

Exposure therapy

Intervention Type BEHAVIORAL

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

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

Group Type PLACEBO_COMPARATOR

Exposure therapy

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

D-cycloserine

50 mg d-cycloserine, oral, 1 dose

Intervention Type DRUG

Exposure therapy

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

Intervention Type BEHAVIORAL

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Tolin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23059145 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NAVE003220HU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.