HealthyPhase 1NCT01736020
Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy
A Phase 1 study testing Dexmedetomidine, Propofol and Ketamine in people with Healthy, run by Southern California Institute for Research and Education at 1 site in United States.
Trial summary
This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dexmedetomidine, Propofol and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults.
- Between the ages of 18 and 35.
Who cannot join
- Pregnancy.
- Left-handed.
- Unusual facial anatomy.
- History of esophageal reflux.
- Respiratory problems.
- Central nervous system disorders.
Show all 16Show fewer
- Cardiovascular problems.
- Kidney disease.
- Diabetes.
- History of Substance abuse.
- History of adverse anesthetic reactions.
- Hepatitis.
- Failure to pass MRI screening questionnaire.
- Fear of small-enclosed spaces.
- Mental illness.
- Non-native English speakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: Developing Anesthesia as PTSD Therapy
This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with PTSD.
- Conditions
- Healthy
- Being tested
- Dexmedetomidine, Propofol, Ketamine, Nitrous Oxide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
PropofolDrug
A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
KetamineDrug
A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Nitrous OxideDrug
A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Dexmedetomidine; Drug: Propofol; Drug: Ketamine; Drug: Nitrous Oxide; Drug: Placebo |
| Dexmedetomidine | Experimental | Dexmedetomidine intravenous infusion during scan. Receives: Drug: Dexmedetomidine |
| Propofol | Experimental | Propofol intravenous infusion during scan. Receives: Drug: Propofol |
| Ketamine | Experimental | Ketamine intravenous infusion during scan. Receives: Drug: Ketamine |
| Nitrous Oxide | Experimental | Nitrous Oxide inhalation during scan. Receives: Drug: Nitrous Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of events remembered
The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.
Measured: Day 4
Secondary outcomes (1)
Event-related fMRI BOLD signals
Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startSep 2009
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Alkire, Southern California Institute for Research and Education
- Investigators
- Michael T Alkire, MD, Principal investigator, University of California, Irvine and Long Beach VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736020
- Sponsor's protocol ID
- MIRB 1007, UCI 2004-3707
- Other IDs
- R34MH087390
- Status last verified
- Oct 2016
- First submitted
- 16 Nov 2012
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Anesthesia as PTSD Therapy
- ClinicalTrials.gov ID
- NCT01736020
- Acronym / sponsor ID
- MIRB 1007, UCI 2004-3707
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Irvine
- Study start
- Sep 2009
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with PTSD.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Dexmedetomidine, Drug: Propofol, Drug: Ketamine, Drug: Nitrous Oxide, Drug: PlaceboPlacebo |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine intravenous infusion during scan. |
| Propofol | Experimental | Drug: PropofolPropofol intravenous infusion during scan. |
| Ketamine | Experimental | Drug: KetamineKetamine intravenous infusion during scan. |
| Nitrous Oxide | Experimental | Drug: Nitrous OxideNitrous Oxide inhalation during scan. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults.
- Between the ages of 18 and 35.
Key exclusion criteria (16 listed)
- Pregnancy.
- Left-handed.
- Unusual facial anatomy.
- History of esophageal reflux.
- Respiratory problems.
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 |
|---|---|---|
| DexmedetomidineA low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability. | Drug | Dexmedetomidine, Placebo |
| PropofolA low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability. | Drug | Placebo, Propofol |
| KetamineA low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability. | Drug | Ketamine, Placebo |
| Nitrous OxideA low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability. | Drug | Nitrous Oxide, Placebo |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Number of events remembered
Time frame: Day 4
The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.
1 secondary outcome
Event-related fMRI BOLD signals
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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.
Michael T Alkire, MD principal investigator
University of California, Irvine and Long Beach VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine, Propofol and Ketamine in people with Healthy, run by Southern California Institute for Research and Education 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 2 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 13 Oct 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of events remembered (time frame: Day 4). 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 13 Oct 2016.