Effect of Propranolol on Preventing Post-Traumatic Stress Disorder
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Traumatic Stress Disorder
Intervention: Propranolol (Drug); Placebo (Drug)
Phase: Phase 4
Sponsored by: Massachusetts General Hospital
Official(s) and/or principal investigator(s):
Roger K. Pitman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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
Official title: Prophylaxis of Post-Traumatic Stress Disorder With Post-Trauma Propranolol
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Psychophysiologic responses to traumatic recollection
Secondary outcome: Post Traumatic Stress Disorder symptoms
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.
Minimum age: 18 Years.
Maximum age: 55 Years.
- Experienced an acute psychological traumatic event
- Heart rate of 80 bpm or greater
- Understands English
- Traumatic event that occurred more than four hours before arrival to emergency
- 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
Locations and Contacts
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Starting date: August 2004
Last updated: April 26, 2013