NCT01665573

Cannabinoid Augmentation of Fear Response in Humans

Completed EARLY_PHASE1 Last updated 11 March 2022

What this trial tests

EARLY_PHASE1 trial testing PF-04457845 in Fear Conditioning in 31 participants. Completed in 16 October 2015.

Timeline

17 July 2012

Primary endpoint
16 October 2015

16 October 2015

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	31
Start date	17 July 2012
Primary completion	16 October 2015
Estimated completion	16 October 2015
Sites	1 location across United States

Drugs / interventions tested

• PF-04457845
• Placebo

Conditions studied

• Fear Conditioning — all drugs for Fear Conditioning →

Sponsor

Yale University

Who can join

Adults 18 to 65, any sex, with Fear Conditioning. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amygdala FAAH and anandamide: mediating protection and recovery from stress.
   Gunduz-Cinar O, Hill MN, McEwen BS, Holmes A. · · 2013 · cited 178× · PMID 24325918 · DOI 10.1016/j.tips.2013.08.008
2. Emerging drugs for the treatment of anxiety.
   Murrough JW, Yaqubi S, Sayed S, Charney DS. · · 2015 · cited 91× · PMID 26012843 · DOI 10.1517/14728214.2015.1049996
3. Targeting the Endocannabinoid System in the Treatment of Posttraumatic Stress Disorder: A Promising Case of Preclinical-Clinical Translation?
   Mayo LM, Rabinak CA, Hill MN, Heilig M. · · 2022 · cited 69× · PMID 34598785 · DOI 10.1016/j.biopsych.2021.07.019
4. Meet Your Stress Management Professionals: The Endocannabinoids.
   deRoon-Cassini TA, Stollenwerk TM, Beatka M, Hillard CJ. · · 2020 · cited 46× · PMID 32868170 · DOI 10.1016/j.molmed.2020.07.002
5. The endocannabinoid system in the amygdala and modulation of fear.
   Gunduz-Cinar O. · · 2021 · cited 28× · PMID 32976951 · DOI 10.1016/j.pnpbp.2020.110116
6. Cannabinoids, Inner Ear, Hearing, and Tinnitus: A Neuroimmunological Perspective.
   Perin P, Mabou Tagne A, Enrico P, Marino F, et al · · 2020 · cited 8× · PMID 33329293 · DOI 10.3389/fneur.2020.505995
7. The role of cannabinoids in shaping lifespan neurodevelopment.
   Marusak HA. · · 2022 · cited 3× · PMID 35106825 · DOI 10.1002/jnr.25012
8. Enhancing anandamide signalling through fatty acid amide hydrolase inhibition: An update on the pharmacological strategy for treating psychiatric disorders.
   Couttas TA, Hoffmann AE, Jieu B, Golla FR, et al · · 2026 · PMID 42209468 · DOI 10.1038/s41398-026-04120-4