PhobiasNCT00767767
The Effect of Intravenous Anesthetics on Fear Learning and Memory
A study testing Propofol 0.45mcg/mL, Propofol 0.90mcg/mL and Thiopental 1.5mcg/mL in people with Phobias, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
People often develop fearful responses to things, but have no conscious control over the fear. This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobias
- What is being tested?
- Propofol 0.45mcg/mL, Propofol 0.90mcg/mL and Thiopental 1.5mcg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 50
- minimum of high school education
- fluent in English
- normal vocabulary
Who cannot join
- any significant medical or psychiatric comorbidity (e.g. asthma, diabetes, hypertension, depression, high anxiety)--subjects must be in excellent health such that they would be classified as American Society of Anesthesiologists Physical Status Class I
- deficit in vision or hearing that would impede the study
- allergies to any of the study drugs, to soybeans, or to eggs
- a history of head trauma
- a family history of major psychiatric illness
- body mass index > 30 kg/m2
Show all 13Show fewer
- a recent history of recreational drug use
- prior exposure to the study materials
- pregnancy
- a personal or family history of any porphyria
- failure to exhibit a skin conductance response to deep inspiration
- the ability to read Chinese characters
- assessment by the investigators that the subject may be unable to cooperate or comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065
About this study
People often develop fearful responses to things, but have no conscious control over the fear. This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear memories.
To address this question, the investigators will study 114 healthy adult volunteer subjects. The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the bloodstream). The dose is so low that the subject might not even be able tell if they are getting the drug. While they are receiving the drug, the subject will perform a series of memory tests and a fear conditioning experiment, which are set up like a very simple computer game. To create the "fear response", subjects will occasionally receive a mildly uncomfortable shock to their arm. The subject is able to determine the highest level of shock that they will receive.
The investigators are doing this study because the investigators wish to know exactly how the drugs affect the way people process fear and emotion. This knowledge might one day be used in the treatment of some psychiatric disorders.
Read the detailed description
People often develop fearful responses to things, but have no conscious control over the fear (e.g. phobias). This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear memories.
To address this question, the investigators will study 114 healthy adult volunteer subjects. The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the bloodstream). The dose is so low that the subject might not even be able tell if they are getting the drug. While they are receiving the drug, the subject will perform a series of memory tests and a fear conditioning experiment, which are set up like a very simple computer game. To create the "fear response", subjects will occasionally receive a mildly uncomfortable shock to their arm. The subject is able to determine the highest level of shock that they will receive.
The investigators are doing this study because the investigators wish to know exactly how the drugs affect the way people process fear and emotion. This knowledge might one day be used in the treatment of some psychiatric disorders.
- Conditions
- Phobias
- Being tested
- Placebos, Propofol 0.45mcg/mL, Propofol 0.90mcg/mL, Thiopental 1.5mcg/mL, Thiopental 3mcg/mL
- Keywords
- anesthetic drugs, associative memory, fear
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
IV Saline infusion for 2 hours.
Propofol 0.45mcg/mLDrug
Also called Propofol
IV Propofol infusion for 2 hours.
Propofol 0.90mcg/mLDrug
Also called Propofol
IV Propofol infusion for 2 hours.
Thiopental 1.5mcg/mLDrug
Also called Thiopental
IV Thiopental 1.5mcg/mL infusion for 2 hours
Thiopental 3mcg/mLDrug
Also called Thiopental
IV Thiopental 3mcg/mL infusion for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Placebos | Placebo comparator | Saline Infusion Receives: Drug: Placebos |
| Propofol 0.45mcg/mL | Active comparator | Anesthetic Drug Infusion Receives: Drug: Propofol 0.45mcg/mL |
| Propofol 0.90mcg/mL | Active comparator | Anesthetic Drug Infusion Receives: Drug: Propofol 0.90mcg/mL |
| Thiopental 1.5mcg/mL | Active comparator | Anesthetic Drug Infusion Receives: Drug: Thiopental 1.5mcg/mL |
| Thiopental 3mcg/mL | Active comparator | Anesthetic Drug Infusion Receives: Drug: Thiopental 3mcg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSR Trial 1
Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)
Measured: First Trial, for up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionMay 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.
- Other trials for PhobiasStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Kane Pryor, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767767
- Sponsor's protocol ID
- 0710009434
- Other IDs
- K08GM083213
- Status last verified
- Apr 2019
- First submitted
- 3 Oct 2008
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Anesthetics on Fear Learning and Memory
- ClinicalTrials.gov ID
- NCT00767767
- Acronym / sponsor ID
- 0710009434
- Conditions
- Phobias
- Keywords
- anesthetic drugs, associative memory, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- Oct 2008 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Oct 2008 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People often develop fearful responses to things, but have no conscious control over the fear. This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear memories.
To address this question, the investigators will study 114 healthy adult volunteer subjects. The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the bloodstream). The dose is so low that the subject might not even be able tell if they are getting the drug. While they are receiving the drug, the subject will perform a series of memory tests and a fear conditioning experiment, which are set up like a very simple computer game. To create the "fear response", subjects will occasionally receive a mildly uncomfortable shock to their arm. The subject is able to determine the highest level of shock that they will receive.
The investigators are doing this study because the investigators wish to know exactly how the drugs affect the way people process fear and emotion. This knowledge might one day be used in the treatment of some psychiatric disorders.
Detailed description
People often develop fearful responses to things, but have no conscious control over the fear (e.g. phobias). This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear memories.
To address this question, the investigators will study 114 healthy adult volunteer subjects. The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the bloodstream). The dose is so low that the subject might not even be able tell if they are getting the drug. While they are receiving the drug, the subject will perform a series of memory tests and a fear conditioning experiment, which are set up like a very simple computer game. To create the "fear response", subjects will occasionally receive a mildly uncomfortable shock to their arm. The subject is able to determine the highest level of shock that they will receive.
The investigators are doing this study because the investigators wish to know exactly how the drugs affect the way people process fear and emotion. This knowledge might one day be used in the treatment of some psychiatric disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebos | Placebo comparator | Drug: PlacebosSaline Infusion |
| Propofol 0.45mcg/mL | Active comparator | Drug: Propofol 0.45mcg/mLAnesthetic Drug Infusion |
| Propofol 0.90mcg/mL | Active comparator | Drug: Propofol 0.90mcg/mLAnesthetic Drug Infusion |
| Thiopental 1.5mcg/mL | Active comparator | Drug: Thiopental 1.5mcg/mLAnesthetic Drug Infusion |
| Thiopental 3mcg/mL | Active comparator | Drug: Thiopental 3mcg/mLAnesthetic Drug Infusion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 50
- minimum of high school education
- fluent in English
- normal vocabulary
Key exclusion criteria (13 listed)
- any significant medical or psychiatric comorbidity (e.g. asthma, diabetes, hypertension, depression, high anxiety)--subjects must be in excellent health such that they would be classified as American Society of Anesthesiologists Physical Status Class I
- deficit in vision or hearing that would impede the study
- allergies to any of the study drugs, to soybeans, or to eggs
- a history of head trauma
- a family history of major psychiatric illness
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 |
|---|---|---|
| PlacebosIV Saline infusion for 2 hours. | Drug | Placebos |
| Propofol 0.45mcg/mLAlso: PropofolIV Propofol infusion for 2 hours. | Drug | Propofol 0.45mcg/mL |
| Propofol 0.90mcg/mLAlso: PropofolIV Propofol infusion for 2 hours. | Drug | Propofol 0.90mcg/mL |
| Thiopental 1.5mcg/mLAlso: ThiopentalIV Thiopental 1.5mcg/mL infusion for 2 hours | Drug | Thiopental 1.5mcg/mL |
| Thiopental 3mcg/mLAlso: ThiopentalIV Thiopental 3mcg/mL infusion for 2 hours | Drug | Thiopental 3mcg/mL |
Primary outcome
GSR Trial 1
Time frame: First Trial, for up to 1 day
Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Phobias
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Effects of Transcranial Direct Current Stimulation and Manual Therapy on Musculoskeletal Pain in Adolescent Dancers
Musculoskeletal Pain, Chronic Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
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.
Kane Pryor, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol 0.45mcg/mL, Propofol 0.90mcg/mL and Thiopental 1.5mcg/mL in people with Phobias, run by Weill Medical College of Cornell University 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 4 inclusion and 13 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 May 2019. 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 10 Apr 2017). 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?
GSR Trial 1 (time frame: First Trial, for up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2019.