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

• Sponsor: Hartford Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01450306
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 1.2

Study Details

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	Phase
Specific Phobia	Drug: D-cycloserine; Behavioral: Exposure therapy; Drug: Placebo	N/A

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
• 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: Jul 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

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) [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Living/Hartford Hospital	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

• Hartford Hospital

Investigators

• Principal Investigator: David Tolin, PhD, Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hartford Hospital
• ClinicalTrials.gov Identifier: NCT01450306
• Other Study ID Numbers: NAVE003220HU
• First Posted: Oct 12, 2011
• Last Update Posted: May 4, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Cycloserine

Study Results

Participant Flow

Arm/Group Title	D-cycloserine Plus Exposure Therapy	Placebo Plus Exposure Therapy
Arm/Group Description	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	Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	D-cycloserine Plus Exposure Therapy	Placebo Plus Exposure Therapy	Total
Arm/Group Description	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	Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39 (13.91)	34.6 (12.69)	37 (13)
Sex: Female, Male (Count of Participants)
Female	6 60%	6 60%	12 60%
Male	4 40%	4 40%	8 40%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Snake Questionnaire (SNAQ)
Description	30-item self-report scale of severity of snake fear and avoidance Range: 0-30; higher values indicate greater fear severity
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-cycloserine Plus Exposure Therapy	Placebo Plus Exposure Therapy
Arm/Group Description	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	Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	9.6 (5.99)	9.7 (6.18)

2. Secondary Outcome

Title	Clinician's Global Impression (CGI)-Severity
Description	Clinician rating of global illness severity (at pre- and post-treatment) CGI-Severity range 1-7; higher scores indicate greater illness severity.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-cycloserine Plus Exposure Therapy	Placebo Plus Exposure Therapy
Arm/Group Description	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	Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	3 (1.15)	2.7 (.68)

3. Secondary Outcome

Title	Clinician's Global Impression (CGI)-Improvement
Description	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
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-cycloserine Plus Exposure Therapy	Placebo Plus Exposure Therapy
Arm/Group Description	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	Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
Measure Participants	10	10
Number [participants]	8 80%	9 90%

Adverse Events

Arm/Group Title	D-cycloserine Plus Exposure Therapy		Placebo Plus Exposure Therapy
Arm/Group Description	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		Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
All Cause Mortality
	D-cycloserine Plus Exposure Therapy		Placebo Plus Exposure Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	D-cycloserine Plus Exposure Therapy		Placebo Plus Exposure Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	D-cycloserine Plus Exposure Therapy		Placebo Plus Exposure Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		0/10 (0%)
Gastrointestinal disorders
Nausea	1/10 (10%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.