Effect of Propranolol on Preventing Posttraumatic Stress Disorder

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Post-Traumatic Stress Disorder

Treatments: Drug: Placebo; Drug: Propranolol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00158262

R01MH068603 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

Posttraumatic 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Experienced an acute psychological traumatic event
• Heart rate of 80 beats per minute (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 beta-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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

43 participants in 2 patient groups, including a placebo group

Propranolol

Experimental group

Description:

Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.

Treatment:

Drug: Propranolol

Placebo

Placebo Comparator group

Description:

Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.

Treatment:

Drug: Placebo