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The Use of Propranolol to Block Memory Reconsolidation in PTSD

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ClinicalTrials.gov Identifier: NCT00611871
Recruitment Status : Terminated (Low enrollment, grant term expired)
First Posted : February 11, 2008
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
John D. Dingell VA Medical Center
New York University
Information provided by (Responsible Party):
Deane Aikins, Wayne State University

Brief Summary:
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 or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Drug: Propranolol Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)
Study Start Date : September 2007
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611871


Locations
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
Investigators
Principal Investigator: Deane Aikins, PhD Wayne State University

Responsible Party: Deane Aikins, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00611871     History of Changes
Other Study ID Numbers: HIC 0703002443
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Propranolol
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