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Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

This study has been completed.
Information provided by (Responsible Party):
Scott Orr, Massachusetts General Hospital Identifier:
First received: June 25, 2012
Last updated: January 3, 2017
Last verified: January 2017
The aim of this project is to create fear conditioning paradigm within which the relative strengths of various novel pharmacological and behavioral interventions can be tested. These interventions are intended to reduce the fearfulness associated with fear conditioning by blocking a memory process known as reconsolidation. In fear conditioning, a "conditioned" stimulus (CS) is paired with an aversive "unconditioned" stimulus (US) such as an electric shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR). The investigators hypothesize that by using a more highly prepared CS (i.e. video of spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional experimental probes for the presence of the latent CR, the investigators may develop a normal human paradigm that is not plagued by previously observed floor effects (i.e. intervention is 100% effective), within which both the established techniques of propranolol and delayed extinction will produce significant, but only partial, CR reduction. This would leave room to test and compare potentially more powerful candidate reconsolidation-blocking or memory-updating interventions. To achieve these aims, subjects will undergo a four-day fear conditioning and delayed extinction protocol. Skin conductance response data will be gathered across the different phases of the experiment.

Condition Intervention Phase
Posttraumatic Stress Disorder
Anxiety Disorder
Drug: Propranolol
Behavioral: Reactivation
Drug: Mifepristone
Drug: Intranasal oxytocin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Psychophysiology of Delayed Extinction and Reconsolidation in Humans

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change From Baseline Skin Conductance Response [ Time Frame: 48hrs ]
    Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.

Enrollment: 186
Study Start Date: November 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propranolol
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Drug: Propranolol
40mg single pill
Other Name: Inderal
Active Comparator: Reactivation with time delay
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction
Behavioral: Reactivation
subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
Experimental: Mifepristone
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Drug: Mifepristone
1800mg, 9 tablets
Other Names:
  • Mifeprex
  • Korlym
Experimental: Intranasal oxytocin
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Drug: Intranasal oxytocin
32 IU, 8 self-administered intranasal sprays, 4 in each nostril
Other Name: Syntocinon

  Show Detailed Description


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-35
  • Top half of the normal human distribution of the Spider Phobia Questionnaire-15

Exclusion Criteria:'

  • Any criteria for diagnosable spider phobia
  • Any current Axis I mental disorder on the Structured Clinical Interview for DSM-IV (SCID)
  • Presence of drugs of abuse (e.g. opiates, marijuana, cocaine, or amphetamines) per urine screen
  • Non-English speaking (due to lack of validated questionnaires/instruments in other languages)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01631682

United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Scott P. Orr, Ph.D. Massachusetts General Hospital
  More Information

Responsible Party: Scott Orr, Associate Professor of Psychology, Massachusetts General Hospital Identifier: NCT01631682     History of Changes
Other Study ID Numbers: W81XWH-11-2-0092
Study First Received: June 25, 2012
Results First Received: September 13, 2016
Last Updated: January 3, 2017

Keywords provided by Massachusetts General Hospital:
Posttraumatic Stress Disorder
Fear of spiders
Reconsolidation blockade

Additional relevant MeSH terms:
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists processed this record on April 21, 2017