The Use of Propranolol to Block Memory Reconsolidation in PTSD
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Posttraumatic Stress Disorders |
Drug: Propranolol Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Use of Propranolol to Block Memory Reconsolidation in Post Traumatic Stress Disorders (PTSD) |
- 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 ]
- Facial corrugator EMG [ Time Frame: Pre- and 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Propranolol following traumatic memory
|
Drug: Propranolol
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
|
|
Active Comparator: 2
Propranolol following neutral memory
|
Drug: Propranolol
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
|
|
Placebo Comparator: 3
Placebo following traumatic memory
|
Drug: Placebo
40mg placebo, followed 2 hrs after with 60mg placebo
|
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 two weeks post-medication administration.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Deane E Aikins, PhD | 203 641 4421 | deane.aikins@yale.edu |
| United States, Connecticut | |
| Yale Center for Clinical Investigations | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Principal Investigator: | Deane Aikins, PhD | Yale University |
More Information
No publications provided
| Responsible Party: | Deane Aikins, Associate Research Scientist, Yale University |
| ClinicalTrials.gov Identifier: | NCT00611871 History of Changes |
| Other Study ID Numbers: | HIC 0703002443, DAIKINS0001 |
| Study First Received: | January 1, 2008 |
| Last Updated: | January 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Propranolol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on May 22, 2013