Fear ConditioningEarly Phase 1NCT01665573
Cannabinoid Augmentation of Fear Response in Humans
A Early Phase 1 study testing PF-04457845 in people with Fear Conditioning, run by Yale University at 1 site in United States.
Trial summary
The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear Conditioning
- What is being tested?
- PF-04457845
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2012to 16 Oct 2015
- Phase
- Early 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65
- Male and female
- No major medical problems
Who cannot join
- Hearing problems
- Psychiatric or mental problems
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On three days over not more than two weeks, subjects will be trained to associate cues with two different stimuli, then this association will be extinguished. Cannabinoid receptor stimulation will be accomplished indirectly by harnessing the brain's capacity to endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845. Some details of this study have not been disclosed to preserve the study design.
- Conditions
- Fear Conditioning
- Being tested
- PF-04457845, Placebo
- Keywords
- Fear Conditioning, Cannabinoids, Fear Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04457845Drug
Acquisition of conditioning Administration of drug Extinction of conditioning
PlaceboDrug
Acquisition of conditioning Administration of placebo Extinction of conditioning
| Study group | Role | What they receive |
|---|---|---|
| PF-04457845 | Active comparator | Acquisition of conditioning Administration of drug Extinction of conditioning Receives: Drug: PF-04457845; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: PF-04457845; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galvanic skin response
Measure of sympathetic autonomic activation
Measured: Test days #1, #2, and #3, on average a week
Cortisol levels measured in blood
Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.
Measured: Test days #1, #2, and #3, on average a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study start17 Jul 2012
- Primary completion16 Oct 2015
- Study completion16 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear ConditioningStudies of the same condition, open and under way.
- More trials run by Yale 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
- Investigators
- Mohini Ranganathan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665573
- Sponsor's protocol ID
- 120303009906
- Status last verified
- Feb 2022
- First submitted
- 11 Jul 2012
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoid Augmentation of Fear Response in Humans
- ClinicalTrials.gov ID
- NCT01665573
- Acronym / sponsor ID
- 120303009906
- Conditions
- Fear Conditioning
- Keywords
- Fear Conditioning, Cannabinoids, Fear Response
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 17 Jul 2012 (actual)
- Primary completion
- 16 Oct 2015 (actual)
- Study completion
- 16 Oct 2015 (actual)
- First posted
- 15 Aug 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.
The purpose of this double blind, randomized, controlled, proof-of-concept study is to test the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On three days over not more than two weeks, subjects will be trained to associate cues with two different stimuli, then this association will be extinguished. Cannabinoid receptor stimulation will be accomplished indirectly by harnessing the brain's capacity to endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845. Some details of this study have not been disclosed to preserve the study design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04457845 | Active comparator | Drug: PF-04457845, Drug: PlaceboAcquisition of conditioning Administration of drug Extinction of conditioning |
| Placebo | Placebo comparator | Drug: PF-04457845, Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 65
- Male and female
- No major medical problems
Key exclusion criteria (2 listed)
- Hearing problems
- Psychiatric or mental 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 |
|---|---|---|
| PF-04457845Acquisition of conditioning Administration of drug Extinction of conditioning | Drug | PF-04457845, Placebo |
| PlaceboAcquisition of conditioning Administration of placebo Extinction of conditioning | Drug | PF-04457845, Placebo |
Primary outcome
Galvanic skin response
Time frame: Test days #1, #2, and #3, on average a week
Measure of sympathetic autonomic activation
Cortisol levels measured in blood
Time frame: Test days #1, #2, and #3, on average a week
Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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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.
Mohini Ranganathan, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PF-04457845 in people with Fear Conditioning, run by Yale 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 3 inclusion and 2 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 11 Mar 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Galvanic skin response (time frame: Test days #1, #2, and #3, on average a week). The study lists 2 primary outcomes in all. 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 11 Mar 2022.