The Use of Propranolol to Block Memory Reconsolidation in PTSD

NCT ID: NCT00611871

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2015-09-30

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.

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.

Conditions

Posttraumatic Stress Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Propranolol following traumatic memory

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection

2

Propranolol following neutral memory

Group Type: ACTIVE_COMPARATOR

Propranolol

Intervention Type: DRUG

40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection

3

Placebo following traumatic memory

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

40mg placebo, followed 2 hrs after with 60mg placebo

Interventions

Propranolol

40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection

Intervention Type: DRUG

Placebo

40mg placebo, followed 2 hrs after with 60mg placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

John D. Dingell VA Medical Center

FED

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Deane Aikins

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deane Aikins, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

John D Dingell VA Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

HIC 0703002443

Identifier Type: -

Identifier Source: org_study_id