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Cannabinoid Augmentation of Fear Response in Humans

This study has suspended participant recruitment.
(IND placed on clinical hold)
Sponsor:
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier:
NCT01665573
First received: July 11, 2012
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Fear Conditioning
Drug: PF-04457845
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Cannabinoid Augmentation of Fear Response in Humans

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Galvanic skin response [ Time Frame: Test days #1, #2, and #3, on average a week ] [ Designated as safety issue: No ]
    Measure of sympathetic autonomic activation

  • Cortisol levels measured in blood [ Time Frame: Test days #1, #2, and #3, on average a week ] [ Designated as safety issue: No ]
    Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.


Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo
Placebo
Drug: PF-04457845
Acquisition of conditioning Administration of drug Extinction of conditioning
Drug: Placebo
Acquisition of conditioning Administration of placebo Extinction of conditioning

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Hearing problems
  • Psychiatric or mental problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665573

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mohini Ranganathan, MD Yale University
  More Information

Responsible Party: Mohini Ranganathan, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01665573     History of Changes
Other Study ID Numbers: 120303009906 
Study First Received: July 11, 2012
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Fear Conditioning
Cannabinoids
Fear Response

ClinicalTrials.gov processed this record on September 26, 2016