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Cannabinoid Augmentation of Fear Response in Humans

This study is currently recruiting participants.
Verified May 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
R. Andrew Sewell, Yale University
ClinicalTrials.gov Identifier:
NCT01665573
First received: July 11, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  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 both directly by administering the exogenous cannabinoid Δ9-tetrahydrocannabinol (THC) and 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, Δ9-tetrahydrocannabinol (THC) 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: Delta-9-THC
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:
  • Startle Probe [ Time Frame: Test days #1, #2, and #3, on average a week ] [ Designated as safety issue: No ]
    Measure of anxiety

  • 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


Estimated Enrollment: 75
Study Start Date: May 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delta-9-THC
Delta-9-THC
 Drug: Delta-9-THC
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
Active Comparator: PF-04457845
Acquisition of conditioning Administration of drug Extinction of conditioning
 Drug: Delta-9-THC
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: Delta-9-THC
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have used cannabis at least once in their lifetime

Exclusion Criteria:

  • Hearing problems
  • Psychiatric or mental problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665573

Contacts
Contact: Lawrence V Rispoli, BA 203-932-5711 ext 2526 lawrence.rispoli@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lawrence V. Rispoli, B.A.     203-932-5711 ext 2526     lawrence.rispoli@yale.edu    
Principal Investigator: R. Andrew Sewell, M.D.            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: R. Andrew Sewell, MD Yale University
  More Information

No publications provided

Responsible Party: R. Andrew Sewell, Associate Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT01665573     History of Changes
Other Study ID Numbers: 120303009906
Study First Received: July 11, 2012
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Fear conditioning
Cannabinoids
Extinction learning

ClinicalTrials.gov processed this record on June 18, 2013