The Use of Propranolol to Block Memory Reconsolidation in PTSD

NCT00611871 | Terminated Phase 2

• 1 other identifier: HIC 0703002443
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorders

Outcome Measures

Primary Outcomes (1)

• Facial corrugator EMG

  Change in Facial corrugator EMG from baseline at 1 month post-intervention

Secondary Outcomes (2)

• CAPS score

  Change in CAPS score from baseline at 1 month post-intervention

• PCL-M score

  Change in PCL-M score from baseline at 1 month post-intervention

Study Arms (3)

1

EXPERIMENTAL

Propranolol following traumatic memory

Drug: Propranolol

2

ACTIVE COMPARATOR

Propranolol following neutral memory

Drug: Propranolol

3

PLACEBO COMPARATOR

Placebo following traumatic memory

Drug: Placebo

Interventions

Propranolol DRUG

40mg propranolol, followed 2 hrs after with 60mg propranolol, immediately following memory recollection

1; 2

Placebo DRUG

40mg placebo, followed 2 hrs after with 60mg placebo

3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants will meet the clinical criteria of PTSD (DSM IVTR) secondary to combat exposure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead
• John D. Dingell VA Medical Center: collaborator
• New York University: collaborator

Study Sites (1)

John D Dingell VA Hospital

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Deane Aikins, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 1, 2008
• First Posted: February 11, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)