The Use of Propranolol to Block Memory Reconsolidation in PTSD

Posttraumatic Stress Disorders Clinical Trial

Official title:

The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00611871
• Other study ID #: HIC 0703002443
• Status: Terminated
• Phase: Phase 2
• First received: January 1, 2008
• Last updated: October 31, 2016
• Start date: September 2007
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Propranolol
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
• Placebo
40mg placebo, followed 2 hrs after with 60mg placebo

Locations

Country	Name	City	State
United States	John D Dingell VA Hospital	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	John D. Dingell VA Medical Center, New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial corrugator EMG		Change in Facial corrugator EMG from baseline at 1 month post-intervention	No
Secondary	CAPS score		Change in CAPS score from baseline at 1 month post-intervention	No
Secondary	PCL-M score		Change in PCL-M score from baseline at 1 month post-intervention	No