Effect of Propranolol on Preventing Posttraumatic Stress Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propranolol

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.

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Propranolol short-acting or long-acting capsule

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo-matching propranolol short-acting or long-acting capsule

Interventions

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Propranolol

Propranolol short-acting or long-acting capsule

Intervention Type DRUG

Placebo

Placebo-matching propranolol short-acting or long-acting capsule

Intervention Type DRUG

Other Intervention Names

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Inderal

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes