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The Use of Propranolol to Block Memory Reconsolidation in PTSD

Primary Purpose

Posttraumatic Stress Disorders

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Placebo
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • John D Dingell VA Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Propranolol following traumatic memory

Propranolol following neutral memory

Placebo following traumatic memory

Outcomes

Primary Outcome Measures

Facial corrugator EMG

Secondary Outcome Measures

CAPS score
PCL-M score

Full Information

First Posted
January 1, 2008
Last Updated
October 31, 2016
Sponsor
Wayne State University
Collaborators
John D. Dingell VA Medical Center, New York University
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1. Study Identification

Unique Protocol Identification Number
NCT00611871
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment, grant term expired
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
John D. Dingell VA Medical Center, New York University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Propranolol following traumatic memory
Arm Title
2
Arm Type
Active Comparator
Arm Description
Propranolol following neutral memory
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo following traumatic memory
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
40mg placebo, followed 2 hrs after with 60mg placebo
Primary Outcome Measure Information:
Title
Facial corrugator EMG
Time Frame
Change in Facial corrugator EMG from baseline at 1 month post-intervention
Secondary Outcome Measure Information:
Title
CAPS score
Time Frame
Change in CAPS score from baseline at 1 month post-intervention
Title
PCL-M score
Time Frame
Change in PCL-M score from baseline at 1 month post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deane Aikins, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
John D Dingell VA Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Use of Propranolol to Block Memory Reconsolidation in PTSD

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