Cannabinoid Augmentation of Fear Response in Humans

NCT ID: NCT01665573

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-17
• Study Completion Date: 2015-10-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

PF-04457845

Acquisition of conditioning Administration of drug Extinction of conditioning

Group Type: ACTIVE_COMPARATOR

PF-04457845

Intervention Type: DRUG

Acquisition of conditioning Administration of drug Extinction of conditioning

Placebo

Intervention Type: DRUG

Acquisition of conditioning Administration of placebo Extinction of conditioning

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

PF-04457845

Intervention Type: DRUG

Acquisition of conditioning Administration of drug Extinction of conditioning

Placebo

Intervention Type: DRUG

Acquisition of conditioning Administration of placebo Extinction of conditioning

Interventions

PF-04457845

Acquisition of conditioning Administration of drug Extinction of conditioning

Intervention Type: DRUG

Placebo

Acquisition of conditioning Administration of placebo Extinction of conditioning

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mohini Ranganathan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohini Ranganathan, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

120303009906

Identifier Type: -

Identifier Source: org_study_id