Cannabinoid Augmentation of Fear Response in Humans

NCT01665573 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 120303009906
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear Conditioning

Keywords

Fear Conditioning; Cannabinoids; Fear Response

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

PF-04457845

ACTIVE COMPARATOR

Acquisition of conditioning Administration of drug Extinction of conditioning

Drug: PF-04457845; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: PF-04457845; Drug: Placebo

Interventions

PF-04457845 DRUG

Acquisition of conditioning Administration of drug Extinction of conditioning

PF-04457845; Placebo

Placebo DRUG

Acquisition of conditioning Administration of placebo Extinction of conditioning

PF-04457845; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hearing problems
• Psychiatric or mental problems

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Interventions

N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide

Study Officials

• Mohini Ranganathan, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: August 15, 2012
• Study Start: July 17, 2012
• Primary Completion: October 16, 2015
• Study Completion: October 16, 2015
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

US (1)