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Cannabinoid Augmentation of Fear Response in Humans

Cannabinoid Augmentation of Fear Response in Humans

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01665573
Enrollment
31
Registered
2012-08-15
Start date
2012-07-17
Completion date
2015-10-16
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear Conditioning

Keywords

Fear Conditioning, Cannabinoids, Fear Response

Brief 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.

Interventions

Acquisition of conditioning Administration of drug Extinction of conditioning

DRUGPlacebo

Acquisition of conditioning Administration of placebo Extinction of conditioning

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Hearing problems * Psychiatric or mental problems

Design outcomes

Primary

MeasureTime frameDescription
Galvanic skin responseTest days #1, #2, and #3, on average a weekMeasure of sympathetic autonomic activation
Cortisol levels measured in bloodTest days #1, #2, and #3, on average a weekSalivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026