Official Title: “The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2009

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 two weeks post-medication administration.

Intervention(s) in this Clinical Trial

• Drug: Propranolol
  • 40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
• Drug: Placebo
  • 40mg placebo, followed 2 hrs after with 60mg placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Propranolol following traumatic memory
• Active Comparator: 2
  • Propranolol following neutral memory
• Placebo Comparator: 3
  • Placebo following traumatic memory

Primary Measures

• Galvanic Skin Response
  • Time Frame: Pre- and post-intervention
    Safety Issue?: No
• Heart rate
  • Time Frame: Pre- and post-intervention
    Safety Issue?: No
• Facial corrugator EMG
  • Time Frame: Pre- and post-intervention
    Safety Issue?: No

Secondary Measures

• CAPS score
  • Time Frame: Pre- and post-intervention
    Safety Issue?: No
• PCL-M score
  • Time Frame: Pre- and post-intervention
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Deane Aikins, PhD Principal Investigator Yale University  

Overall Contact: Deane E Aikins, PhD 203 641 4421 deane.aikins@yale.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00611871

Study ID Number: HIC 0703002443

ClinicalTrials.gov Identifier: NCT00611871

Health Authority: United States: Institutional Review Board