The Use of Propranolol to Block Memory Reconsolidation in PTSD - Full Text View

Sponsors and Collaborators:	Yale University National Center for Posttraumatic Stress Disorder New York University School of Medicine
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00611871

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 II

MedlinePlus related topics: Memory Post-Traumatic Stress Disorder

Drug Information available for: Propranolol Dexpropranolol Propranolol hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)

Further study details as provided by Yale University:

Primary Outcome Measures:

Galvanic Skin Response [ Time Frame: Pre- and post-intervention ] [ Designated as safety issue: No ]
Heart rate [ Time Frame: Pre- and post-intervention ] [ Designated as safety issue: No ]
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:	September 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Propranolol following traumatic memory	Drug: Propranolol 40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
2: Active Comparator Propranolol following neutral memory	Drug: Propranolol 40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
3: Placebo Comparator 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:	Male
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

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

Contacts

Contact: Deane E Aikins, PhD

203 641 4421

deane.aikins@yale.edu

Locations

United States, Connecticut
Yale Center for Clinical Investigations	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Center for Posttraumatic Stress Disorder

New York University School of Medicine

Investigators

Principal Investigator:

Deane Aikins, PhD

Yale University

More Information

Responsible Party:	Yale School of Medicine ( Deane Aikins, PhD Assistant Professor, Department of Psychiatry )
Study ID Numbers:	HIC 0703002443, DAIKINS0001
Study First Received:	January 1, 2008
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00611871
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Propranolol
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 15, 2009