The Use of Propranolol to Block Memory Reconsolidation in PTSD

Condition(s) targeted: Posttraumatic Stress Disorders

Intervention: Propranolol (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Deane Aikins, PhD, Principal Investigator, Affiliation: Yale University

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

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.

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

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

Primary outcome:

Galvanic Skin Response

Heart rate

Facial corrugator EMG

Secondary outcome:

CAPS score

PCL-M score

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 two weeks post-medication administration.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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.

Deane E Aikins, PhD, Phone: 203 641 4421, Email: deane.aikins@yale.edu

Yale Center for Clinical Investigations, New Haven, Connecticut 06519, United States; Recruiting

Starting date: September 2007
Ending date: September 2010
Last updated: February 8, 2008