Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder

Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder

This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.

Study Overview

• Status: Terminated
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Drug: Propanolol; Behavioral: Cognitive therapy workbook; Drug: Placebo

Detailed Description

Post-traumatic stress disorder (PTSD) is a common and disabling condition, with about 10% of people having experienced PTSD at some point during their lives. The diagnosis of PTSD requires certain criteria: exposure to a severe psychological trauma and the persistent presence of three symptom clusters that include re-experiencing the traumatic event, physiologic hyperarousal, and emotional numbing paired with avoidance of stimuli associated with the event. Stimuli and cues associated with the trauma, such as features of an assailant or accident site, can cause a person to re-experience the traumatic memory and associated feelings of helplessness and fear. When re-experiencing a traumatic memory, people with PTSD usually undergo a heightened stress-related hormonal response that further solidifies new stimulating associations with the traumatic memory. Treatment with propranolol, a blood pressure-lowering drug that reduces stress-related hormonal responses, may be an effective means of preventing the formation of traumatic memories and of improving PTSD symptoms. This study will evaluate the effectiveness of propranolol in reducing symptoms of distress associated with traumatic memories in people with PTSD.

Participation in this study will last 14 weeks. All potential participants will undergo a 4-hour initial visit that will begin with a medical and psychiatric history review, a psychiatric interview, and symptom questionnaires. Participants will then be assigned randomly to take a test dose of either propranolol or placebo. Upon completion of the test dose, participants will begin 14 weeks of treatment with their assigned test dose medication. Participants will be asked to take the study medication each time they have a traumatic memory associated with hyperarousal symptoms, but no more than two times a day. Using a cognitive behavioral therapy based-workbook, participants will track their symptoms daily and when they use cognitive techniques to relieve symptoms.

Participants will attend study visits every 2 weeks for the 14 weeks of treatment. During these visits, participants will describe any side effects experienced, complete interviews and questionnaires about PTSD symptom severity, review with study officials their daily workbook entries, and pick up medication. Study participation will end upon completion of the Week 14 study visit.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00391430

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD (event, hyperarousal, re-experiencing, duration, and distress/impaired functioning symptom criteria), but not the avoidance/numbing symptom criteria

Exclusion Criteria:

• Past or current asthma
• Diabetes or heart disease
• Currently pregnant or breastfeeding
• Concurrent use of daily benzodiazepine; daily use of antidepressant medication allowed if dose has been stable for the 3 months before study entry
• Exposure therapy or additional cognitive therapy during the course of the study (supportive psychotherapy is allowed if ongoing for at least 3 months before study entry)
• Substance abuse
• Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or digoxin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Propranolol; Participants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.	Drug: Propanolol; Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.; Other Names: Inderal; Behavioral: Cognitive therapy workbook; Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
PLACEBO_COMPARATOR: Placebo; Participants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day.	Behavioral: Cognitive therapy workbook; Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.; Drug: Placebo; Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)	Scores range from 0-70, higher scores represent more severe symptoms	Measured at Week 0, 2,4,6,8,10,12,14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Measured by Beck Depression Inventory (BDI)	Scores range from 0-30, higher scores represent more severe symptoms	Measured at Weeks 0,2,4,6,8,10,12, 14
Change in Post-traumatic Scale-Self Score (PS-SR)	This is a 17-item self-report scale. Scores range from 0-51, higher scores represent more severe symptoms.	Measured at Weeks 0,2,4,6,8,10,12, 14
Change in Brief Symptoms Inventory-Short Form (BSI-SF)	BSI-SF is an 18 item scale used for a global score of general distress. Scores range from 0-72, higher scores represent more severe symptoms	Measured at Weeks 0,2,4,6,8,10,12, 14

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (ACTUAL): June 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (ESTIMATE): April 1, 2008

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; Cognitive Therapy; Propanolol; Reconsolidation; Beta Blockers
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: P50MH058911-01 (NIH); 0305006139 (OTHER: Weill Cornell IRB)