Official Title: “Prophylaxis of Post-Traumatic Stress Disorder With Post-Trauma Propranolol”

This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of post-traumatic stress disorder in acutely traumatized individuals.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Post-Traumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will assess the effect of post-trauma propranolol on reducing the incidence and severity of PTSD. The study will also evaluate propranolol's effectiveness as a preventive measure against subsequent PTSD symptoms.

Participants in this double-blind study will be recruited upon admission to the Massachusetts General Hospital Emergency Department after exposure to a psychologically traumatic event.

Baseline psychometric and psychobiologic measurements will be collected. Within 6 hours following the traumatic event, participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo. For the next 10 days, participants will receive 120 mg of either long-acting propranolol or placebo twice daily. A 9-day medication tapering will follow. Participants will undergo psychophysiologic, psychodiagnostic, and psychometric testing for PTSD 1 and 3 months following the traumatic event.

Intervention(s) in this Clinical Trial

• Drug: Propranolol

Primary Measures

• Psychophysiologic responses to traumatic recollection, Months 1 and 3

Secondary Measures

• Post Traumatic Stress Disorder symptoms, Months 1 and 3

Inclusion Criteria:

• Experienced an acute psychological traumatic event
• Heart rate of 80 bpm or greater
• Understands English

Exclusion Criteria:

• Traumatic event that occurred more than four hours before arrival to emergency department
• Physical injury that may affect safe participation (e.g., head injury)
• Systolic blood pressure less than 100 mm Hg
• Medical or surgical condition that poses a risk of shock
• Medical condition that may affect the safe administration of propranolol
• Previous adverse reaction to, or non-compliance with, a B-blocker
• Current use of medication that may react badly with propranolol
• Elevated saliva alcohol level
• Presence of salivary opiates, marijuana, cocaine, or amphetamines
• Pregnant or breastfeeding
• Traumatic event reflecting ongoing victimization
• Psychiatric condition that may affect safe participation
• Unwilling or unable to commute to Boston for research visits
• Attending physician in emergency department does not advise participation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Roger K. Pitman, MD Principal Investigator Massachusetts General Hospital  

Overall Contact: Roger K. Pitman, MD 617-726-5333 roger_pitman@hms.harvard.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00158262

Study ID Number: R01 MH68603

ClinicalTrials.gov Identifier: NCT00158262

Health Authority: United States: Federal Government