Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

Posttraumatic Stress Disorder Clinical Trial

Official title:

Psychophysiology of Delayed Extinction and Reconsolidation in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631682
• Other study ID #: W81XWH-11-2-0092
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2012
• Last updated: May 5, 2015
• Start date: November 2010
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Partners Human Research CommitteeUnited States: Food and Drug AdministrationUnited States: U.S. Army Human Research Protection Office (HRPO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Disease
• Posttraumatic Stress Disorder
• Reconsolidation
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Propranolol
40mg single pill

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)

Drug:
• Mifepristone
1800mg, 9 tablets
• Intranasal oxytocin
32 IU, 8 self-administered intranasal sprays, 4 in each nostril

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline skin conductance response	Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will compare the SCR measurements on day 2 to those acquired during fear conditioning acquisition on day 1.	24hrs	No
Primary	Baseline skin conductance response	Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will use these baseline data as a point of comparison at future time points.	0hrs	No
Primary	Change from baseline skin conductance	Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will compare the SCR measurements on day 3 to baseline and day 2.	48hrs	No
Primary	Change in skin conductance response	Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will compare the SCR measurements on day 30 to baseline, day 2, and day 3.	30 days (plus or minus 3 days)	No