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The Use of Propranolol to Block Memory Reconsolidation in PTSD

This study has been terminated.
(Low enrollment, grant term expired)
John D. Dingell VA Medical Center
New York University
Information provided by (Responsible Party):
Deane Aikins, Wayne State University Identifier:
First received: January 1, 2008
Last updated: October 31, 2016
Last verified: October 2016
The purpose of this investigation is to see if propranolol will reduce the psychophysiological hyperactivation associated with memories of combat stress in Veterans with Posttraumatic Stress Disorder.

Condition Intervention Phase
Posttraumatic Stress Disorders
Drug: Propranolol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)

Resource links provided by NLM:

Further study details as provided by Deane Aikins, Wayne State University:

Primary Outcome Measures:
  • Facial corrugator EMG [ Time Frame: Change in Facial corrugator EMG from baseline at 1 month post-intervention ]

Secondary Outcome Measures:
  • CAPS score [ Time Frame: Change in CAPS score from baseline at 1 month post-intervention ]
  • PCL-M score [ Time Frame: Change in PCL-M score from baseline at 1 month post-intervention ]

Enrollment: 12
Study Start Date: September 2007
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Propranolol following traumatic memory
Drug: Propranolol
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
Active Comparator: 2
Propranolol following neutral memory
Drug: Propranolol
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
Placebo Comparator: 3
Placebo following traumatic memory
Drug: Placebo
40mg placebo, followed 2 hrs after with 60mg placebo

Detailed Description:
The goal of this translational research project is to generate a pilot sample of data from an investigation of a novel therapeutic approach to post traumatic stress disorder (PTSD). Current treatments for PTSD include exposure and other aspects of cognitive therapy as well as drug therapies based on serotonin-reuptake inhibiting antidepressant agents. However, these treatments are often unsuccessful, and symptoms in affected individuals may persist for decades. The central hypothesis guiding this research project posits that acquired fear responses, such as those in PTSD, when reactivated by recall become sensitive to noradrenergic modulation and thus may be permanently attenuated by blocking noradrenergic transmission. Further, we predict that this attenuation will facilitate subsequent therapy. In the current study, we will be investigating this model in three groups of Veterans of either Operation Iraqi Freedom or Operation Enduring Freedom (OIF/OEF) with PTSD: 1) Individuals who receive propranolol following recall of a traumatic memory (Propranolol-trauma); 2) Individuals who receive a placebo following recall of a traumatic memory (Placebo-trauma), and; 3) Individuals who receive propranolol following recall of an affective neutral memory (Propranolol-neutral). In addition, traumatic memory recall will be psychophysiologically assessed by measuring Veterans' facial corrugator electromyography (EMG), skin conductance, blood pressure and cardiovascular inter-beat interval responses pre- and one month post-medication administration.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants will meet the clinical criteria of PTSD (DSM IVTR) secondary to combat exposure.

Exclusion Criteria:

  • Current illicit substance use or alcohol consumption, as determined by urine toxicology and alcohol breath test.
  • Any diagnosis of current comorbid psychotic disorders, bipolar disorder, or illicit substance or alcohol abuse or dependence.
  • Any current prescription medication usage or supplement (dietary or herbal) usage that is contraindicated with propranolol.
  • Active enrollment into any psychiatric or psychological treatment.
  • Any condition that contraindicates the use of propranolol, such as:

    • history of bronchial asthma.
    • heart block.
    • sinus bradycardia.
    • congestive heart failure.
    • insulin-dependent diabetes.
    • initial systolic blood pressure < 100 mmHg.
    • Hyperthyroidism.
    • Thyroid disease.
    • Renal or liver impairment.
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Please refer to this study by its identifier: NCT00611871

United States, Michigan
John D Dingell VA Hospital
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
John D. Dingell VA Medical Center
New York University
Principal Investigator: Deane Aikins, PhD Wayne State University
  More Information

Responsible Party: Deane Aikins, Associate Professor, Wayne State University Identifier: NCT00611871     History of Changes
Other Study ID Numbers: HIC 0703002443
Study First Received: January 1, 2008
Last Updated: October 31, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents processed this record on May 25, 2017