CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 186 enrolled
Drug / intervention
Propranolol +3 moredrug
Likely dose
Propranolol 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01631682
NCT01631682Phase 4Completed

Psychophysiology of Delayed Extinction and Reconsolidation in Humans

Massachusetts General Hospital·interventional·Posted Jun 29, 2012·Updated Feb 23, 2017

In Brief

A Phase 4 clinical trial evaluating Propranolol, Reactivation, and 2 other interventions for Posttraumatic Stress Disorder and Anxiety Disorder. Completed, enrolled 186 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2012
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.0 years ago

Interventions

Propranololdrug

40mg single pill

Reactivationbehavioral

subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)

Mifepristonedrug

1800mg, 9 tablets

Intranasal oxytocindrug

32 IU, 8 self-administered intranasal sprays, 4 in each nostril