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The Use of Propranolol to Block Memory Reconsolidation in PTSD

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Wayne State University
Sponsor:
Collaborators:
John D. Dingell VA Medical Center
New York University
Information provided by (Responsible Party):
Deane Aikins, Wayne State University
ClinicalTrials.gov Identifier:
NCT00611871
First received: January 1, 2008
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Wayne State University:

Primary Outcome Measures:
  • Facial corrugator EMG [ Time Frame: Pre- and post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CAPS score [ Time Frame: Pre- and post-intervention ] [ Designated as safety issue: No ]
  • PCL-M score [ Time Frame: Pre- and post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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 two weeks post-medication administration.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611871

Contacts
Contact: Deane E Aikins, PhD 203 641 4421 deaikins@med.wayne.edu

Locations
United States, Michigan
John D Dingell VA Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Deane Aikins, PhD    203-641-4421      
Sponsors and Collaborators
Wayne State University
John D. Dingell VA Medical Center
New York University
Investigators
Principal Investigator: Deane Aikins, PhD Wayne State University
  More Information

No publications provided

Responsible Party: Deane Aikins, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00611871     History of Changes
Other Study ID Numbers: HIC 0703002443, DAIKINS0001
Study First Received: January 1, 2008
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014