Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders
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Purpose
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 Reconsolidation |
Drug: Propranolol Behavioral: Reactivation |
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 |
- Change from baseline skin conductance response [ Time Frame: 24hrs ] [ Designated as safety issue: No ]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.
- Baseline skin conductance response [ Time Frame: 0hrs ] [ Designated as safety issue: No ]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.
- Change from baseline skin conductance [ Time Frame: 48hrs ] [ Designated as safety issue: No ]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.
- Change in skin conductance response [ Time Frame: 30 days (plus or minus 3 days) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 85 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | January 2013 (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
|
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| 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| Contact: Scott Orr, Ph.D. | (617) 643-7269 | scott_orr@hms.harvard.edu |
| Contact: Justin Spring, M.A. | (617) 643-4780 | jspring@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Charlestown, Massachusetts, United States, 02129 | |
| Contact: Justin Spring, M.A. 617-643-4780 jspring@partners.org | |
| Principal Investigator: Scott Orr, Ph.D. | |
| Sub-Investigator: Roger Pitman, M.D. | |
More Information
No publications provided
| Responsible Party: | Scott Orr, Associate Professor of Psychology, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01631682 History of Changes |
| Other Study ID Numbers: | W81XWH-11-2-0092 |
| Study First Received: | June 25, 2012 |
| Last Updated: | June 27, 2012 |
| Health Authority: | United States: Partners Human Research Committee United States: Food and Drug Administration United States: U.S. Army Human Research Protection Office (HRPO) |
Keywords provided by Massachusetts General Hospital:
|
Posttraumatic Stress Disorder PTSD Anxiety |
Fear of spiders Reconsolidation Reconsolidation blockade |
Additional relevant MeSH terms:
|
Anxiety Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Mental Disorders Propranolol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on May 16, 2013