The Use of Propranolol to Block Memory Reconsolidation in PTSD

This study has been terminated.
(Low enrollment, grant term expired)
Sponsor:
Collaborators:
John D. Dingell VA Medical Center
New York University
Information provided by (Responsible Party):
Deane Aikins, Wayne State University
ClinicalTrials.gov Identifier:
NCT00611871
First received: January 1, 2008
Last updated: August 14, 2015
Last verified: August 2015

January 1, 2008
August 14, 2015
September 2007
October 2015   (final data collection date for primary outcome measure)
Facial corrugator EMG [ Time Frame: Change in Facial corrugator EMG from baseline at 1 month post-intervention ] [ Designated as safety issue: No ]
  • Facial corrugator EMG [ Time Frame: Pre- and post-intervention ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00611871 on ClinicalTrials.gov Archive Site
  • CAPS score [ Time Frame: Change in CAPS score from baseline at 1 month post-intervention ] [ Designated as safety issue: No ]
  • PCL-M score [ Time Frame: Change in PCL-M score from baseline at 1 month post-intervention ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
The Use of Propranolol to Block Memory Reconsolidation in PTSD
The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Posttraumatic Stress Disorders
  • Drug: Propranolol
    40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
  • Drug: Placebo
    40mg placebo, followed 2 hrs after with 60mg placebo
  • Experimental: 1
    Propranolol following traumatic memory
    Intervention: Drug: Propranolol
  • Active Comparator: 2
    Propranolol following neutral memory
    Intervention: Drug: Propranolol
  • Placebo Comparator: 3
    Placebo following traumatic memory
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
December 2015
October 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611871
HIC 0703002443, DAIKINS0001
No
Deane Aikins, Wayne State University
Wayne State University
  • John D. Dingell VA Medical Center
  • New York University
Principal Investigator: Deane Aikins, PhD Wayne State University
Wayne State University
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP