Propranolol Injection |
Inderal IV |
Clinical Trial: Effect of Propranolol on Preventing Post-Traumatic Stress Disorder
This study is currently recruiting patients.
Verified by National Institute of Mental Health (NIMH) September 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Stress Disorders, Post Traumatic | Drug: Propranolol | Phase IV |
MedlinePlus related topics: Post-Traumatic Stress Disorder
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Prophylaxis of Post-Traumatic Stress Disorder with Post-Trauma Propranolol
Secondary Outcomes: Post Traumatic Stress Disorder symptoms, Months 1 and 3
Expected Total Enrollment: 128
Study start: August 2004
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 propanolol on reducing the incidence and severity of PTSD. The study will also evaluate propanolol’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 propanolol or placebo and 60 mg of either long-acting propanolol or placebo. For the next 10 days, participants will receive 120 mg of either long-acting propanolol 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.
Eligibility
Accepts Healthy Volunteers
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
Location and Contact Information
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Recruiting
Mark Pollack, MD, Sub-Investigator
Randall M Zusman, MD, Sub-Investigator
Scott P Orr, PhD, Sub-Investigator
Natasha Lasko, PhD, Sub-Investigator
Yuchiao Chang, PhD, Sub-Investigator
Roger K Pitman, MD, Principal Investigator
Glen Saxe, MD, Sub-Investigator
Brigham and Women''''s Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Thomas Stair, MD, Sub-Investigator
Roger K. Pitman, MD, Principal Investigator, Massachusetts General Hospital
More Information
Last Updated: September 10, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00158262
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Inderal IV (Drug Digest)
- Propranolol Injection (Drug Digest)

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