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Clinical Trials/NCT00611871
NCT00611871TerminatedPhase 2

The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)

Wayne State University1 site in 1 country12 target enrollmentStarted: September 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
12
Locations
1
Primary Endpoint
Facial corrugator EMG

Study Overview

Brief Summary

The purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in Veterans with Posttraumatic Stress Disorder.

Detailed Description

The goal of this translational research project is to generate a pilot sample of data from an investigation of a novel therapeutic approach to post traumatic stress disorder (PTSD). Current treatments for PTSD include exposure and other aspects of cognitive therapy as well as drug therapies based on serotonin-reuptake inhibiting antidepressant agents. However, these treatments are often unsuccessful, and symptoms in affected individuals may persist for decades. The central hypothesis guiding this research project posits that acquired fear responses, such as those in PTSD, when reactivated by recall become sensitive to noradrenergic modulation and thus may be permanently attenuated by blocking noradrenergic transmission. Further, we predict that this attenuation will facilitate subsequent therapy. In the current study, we will be investigating this model in three groups of Veterans of either Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) with PTSD: 1) Individuals who receive propranolol following recall of a traumatic memory (Propranolol-trauma); 2) Individuals who receive a placebo following recall of a traumatic memory (Placebo-trauma), and; 3) Individuals who receive propranolol following recall of an affective neutral memory (Propranolol-neutral). In addition, traumatic memory recall will be psychophysiologically assessed by measuring Veterans' facial corrugator electromyography (EMG), skin conductance, blood pressure and cardiovascular inter-beat interval responses pre- and one month post-medication administration.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants will meet the clinical criteria of PTSD (DSM IVTR) secondary to combat exposure.

Exclusion Criteria

  • Current illicit substance use or alcohol consumption, as determined by urine toxicology and alcohol breath test.
  • Any diagnosis of current comorbid psychotic disorders, bipolar disorder, or illicit substance or alcohol abuse or dependence.
  • Any current prescription medication usage or supplement (dietary or herbal) usage that is contraindicated with propranolol.
  • Active enrollment into any psychiatric or psychological treatment.
  • Any condition that contraindicates the use of propranolol, such as:
  • history of bronchial asthma.
  • heart block.
  • sinus bradycardia.
  • congestive heart failure.
  • insulin-dependent diabetes.
  • initial systolic blood pressure < 100 mmHg.
  • Hyperthyroidism.
  • Thyroid disease.
  • Renal or liver impairment.

Arms & Interventions

1

Experimental

Propranolol following traumatic memory

Intervention: Propranolol (Drug)

2

Active Comparator

Propranolol following neutral memory

Intervention: Propranolol (Drug)

3

Placebo Comparator

Placebo following traumatic memory

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Facial corrugator EMG

Time Frame: Change in Facial corrugator EMG from baseline at 1 month post-intervention

Secondary Outcomes

  • CAPS score(Change in CAPS score from baseline at 1 month post-intervention)
  • PCL-M score(Change in PCL-M score from baseline at 1 month post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Deane Aikins

Associate Professor

Wayne State University

Study Sites (1)

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