Cannabinoid Augmentation of Fear Response in Humans

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 Overview

• Status: Completed
• Conditions: Fear Conditioning
• Intervention / Treatment: Drug: PF-04457845; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: PF-04457845; Acquisition of conditioning Administration of drug Extinction of conditioning; Drug: Placebo; Acquisition of conditioning Administration of placebo Extinction of conditioning
ACTIVE_COMPARATOR: PF-04457845; Acquisition of conditioning Administration of drug Extinction of conditioning	Drug: PF-04457845; Acquisition of conditioning Administration of drug Extinction of conditioning; Drug: Placebo; Acquisition of conditioning Administration of placebo Extinction of conditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Galvanic skin response	Measure of sympathetic autonomic activation	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.	Test days #1, #2, and #3, on average a week

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2012
• Primary Completion (ACTUAL): October 16, 2015
• Study Completion (ACTUAL): October 16, 2015

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: August 9, 2012
• First Posted (ESTIMATE): August 15, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Fear Conditioning; Cannabinoids; Fear Response
• Other Study ID Numbers: 120303009906

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No