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Cannabinoid Augmentation of Fear Response in Humans

Early Phase 1
Completed
Conditions
Fear Conditioning
Interventions
Drug: Placebo
Registration Number
NCT01665573
Lead Sponsor
Yale University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
Inclusion Criteria
  • Between the ages of 18 and 65
  • Male and female
  • No major medical problems
Exclusion Criteria
  • Hearing problems
  • Psychiatric or mental problems

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PF-04457845PlaceboAcquisition of conditioning Administration of drug Extinction of conditioning
PlaceboPlaceboPlacebo
PF-04457845PF-04457845Acquisition of conditioning Administration of drug Extinction of conditioning
PlaceboPF-04457845Placebo
Primary Outcome Measures
NameTimeMethod
Galvanic skin responseTest days #1, #2, and #3, on average a week

Measure of sympathetic autonomic activation

Cortisol levels measured in bloodTest 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

VA Connecticut Healthcare System

🇺🇸

West Haven, Connecticut, United States

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