The Use of Propranolol to Block Memory Reconsolidation in PTSD

Wayne State University

Status and phase: Terminated; Phase 2

Conditions: Posttraumatic Stress Disorders

Treatments: Drug: Placebo; Drug: Propranolol

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00611871

HIC 0703002443

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

12 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Propranolol following traumatic memory

Treatment:

Drug: Propranolol

2

Active Comparator group

Description:

Propranolol following neutral memory

Treatment:

Drug: Propranolol

3

Placebo Comparator group

Description:

Placebo following traumatic memory

Treatment:

Drug: Placebo