Clinical trial NCT00611871: The Use of Propranolol to Block Memory Reconsolidation in PTSD
Official title: The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorders
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: John D. Dingell VA Medical Center
name: New York University
First posted: 2008-02-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Facial corrugator EMG
timeFrame: Change in Facial corrugator EMG from baseline at 1 month post-intervention
Secondary outcomes:
measure: CAPS score
timeFrame: Change in CAPS score from baseline at 1 month post-intervention
measure: PCL-M score
timeFrame: Change in PCL-M score from baseline at 1 month post-intervention
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D Dingell VA Hospital
state: Michigan
Study officials:
affiliation: Wayne State University
name: Deane Aikins, PhD
role: PRINCIPAL_INVESTIGATOR
References: