Specific PhobiaNCT01450306
Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
A study testing D-cycloserine and Exposure therapy in people with Specific Phobia, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Specific Phobia
- What is being tested?
- D-cycloserine and Exposure therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of specific phobia (snakes)
Who cannot join
- History of psychosis, obsessive-compulsive disorder, or mania
- Recent substance abuse or suicidality
- Previous receipt of study treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Conditions
- Specific Phobia
- Being tested
- D-cycloserine, Exposure therapy, Placebo
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
50 mg d-cycloserine, oral, 1 dose
Exposure therapyBehavioural
Single session graded in vivo exposure therapy, 60-180 minutes
PlaceboDrug
Single capsule of oral placebo, administered once 1 hr prior to exposure therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Exposure therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snake Questionnaire (SNAQ)
30-item self-report scale of severity of snake fear and avoidance
Range: 0-30; higher values indicate greater fear severity
Measured: 2 weeks
Secondary outcomes (2)
Clinician's Global Impression (CGI)-Severity
Clinician rating of global illness severity (at pre- and post-treatment)
CGI-Severity range 1-7; higher scores indicate greater illness severity.
Measured: 2 weeks
Clinician's Global Impression (CGI)-Improvement
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Tolin, PhD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450306
- Sponsor's protocol ID
- NAVE003220HU
- Status last verified
- Mar 2024
- First submitted
- 6 Oct 2011
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data will be made available upon request
Publications
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.
PubMed 23059145
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics
- ClinicalTrials.gov ID
- NCT01450306
- Acronym / sponsor ID
- NAVE003220HU
- Conditions
- Specific Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Posted 21 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine plus exposure therapy | Experimental | Drug: D-cycloserine, Behavioral: Exposure therapySingle session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session |
| Placebo plus exposure therapy | Placebo comparator | Behavioral: Exposure therapy, Drug: PlaceboSingle session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of specific phobia (snakes)
Key exclusion criteria (3 listed)
- History of psychosis, obsessive-compulsive disorder, or mania
- Recent substance abuse or suicidality
- Previous receipt of study treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-cycloserine50 mg d-cycloserine, oral, 1 dose | Drug | D-cycloserine plus exposure therapy |
| Exposure therapySingle session graded in vivo exposure therapy, 60-180 minutes | Behavioural | D-cycloserine plus exposure therapy, Placebo plus exposure therapy |
| PlaceboSingle capsule of oral placebo, administered once 1 hr prior to exposure therapy | Drug | Placebo plus exposure therapy |
Primary outcome
Snake Questionnaire (SNAQ)
Time frame: 2 weeks
30-item self-report scale of severity of snake fear and avoidance Range: 0-30; higher values indicate greater fear severity
2 secondary outcomes
Clinician's Global Impression (CGI)-Severity
Time frame: 2 weeks
Clinician's Global Impression (CGI)-Improvement
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23059145Nave 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.
- Individual participant dataSharing planned: Yes. De-identified data will be made available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tolin, PhD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-cycloserine and Exposure therapy in people with Specific Phobia, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snake Questionnaire (SNAQ) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.