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CompletedNCT01665573Updated Mar 11, 2022

Cannabinoid Augmentation of Fear Response in Humans

An Early Phase 1 interventional study of PF-04457845 and Placebo in Fear Conditioning, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Yale University · Early Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Oct 2015, 10 years 11 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Fear Conditioning

Keywords

  • Fear Conditioning
  • Cannabinoids
  • Fear Response
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Between the ages of 18 and 65
  • Male and female
  • No major medical problems

Exclusion criteria

Exclusion Criteria:

  • Hearing problems
  • Psychiatric or mental problems
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Active comparator
    PF-04457845

    Acquisition of conditioning Administration of drug Extinction of conditioning

    Drug: PF-04457845 · Drug: Placebo

  • Placebo comparator
    Placebo

    Placebo

    Drug: PF-04457845 · Drug: Placebo

Interventions

  • DrugPF-04457845

    Acquisition of conditioning Administration of drug Extinction of conditioning

  • DrugPlacebo

    Acquisition of conditioning Administration of placebo Extinction of conditioning

06

What researchers measure

Primary outcomes

  1. Galvanic skin response

    Measure of sympathetic autonomic activation

    Time frame: Test days #1, #2, and #3, on average a week

  2. Cortisol levels measured in blood

    Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.

    Time frame: Test days #1, #2, and #3, on average a week

07

Study locations

1 site
  • VA Connecticut Healthcare System
    West Haven, Connecticut 06516, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01665573
Lead sponsor
Yale University
Responsible party
Mohini Ranganathan (Assistant Professor, Yale University) — Principal investigator
First posted
Aug 15, 2012
Start date
Jul 17, 2012
Primary completion
Oct 16, 2015
Completion
Oct 16, 2015
Last update
Mar 11, 2022

Study contacts

Mohini Ranganathan, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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