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Completed

NCT Number: NCT01665573

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.

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Key information

Conditions

Fear Conditioning

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hearing problems
  • Psychiatric or mental problems

Treatment and study plan

PF-04457845

Drug

Acquisition of conditioning Administration of drug Extinction of conditioning

Placebo

Drug

Acquisition of conditioning Administration of placebo Extinction of conditioning

Primary outcomes

  1. Galvanic skin response

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

    Measure of sympathetic autonomic activation

  2. Cortisol levels measured in blood

    Time frame: Test 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 15, 2012
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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