Reducing Reconsolidation of Trauma Memories With Propranolol

Posttraumatic Stress Disorder Clinical Trial

Official title:

Reduction of the Reconsolidation of the Trauma Memory With Propranolol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01349439
• Other study ID #: 08-44
• Status: Recruiting
• Phase: Phase 2
• First received: March 31, 2011
• Last updated: June 23, 2014
• Start date: March 2011

Study information

• Verified date: June 2014
• Source: Douglas Mental Health University Institute
• Contact: Alain R Brunet, Ph.D.
• Phone: 514-761-6131
• Email: alain.brunet[@]mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether propranolol is capable of reducing subsequent physiological trauma-related conditioned responses, as well as self-reported post-traumatic stress disorder (PTSD) symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Suffer from chronic PTSD for at least 6 consecutive months;

• Obtain a score of 33 or more on the Impact of Events Scale-Revised:

• For participants aged 40 years: accept to undergo an electrocardiogram assessment. The results of the electrocardiogram must be normal;

• Accept to not commence taking new medications on a regular basis during the study.

Exclusion Criteria:

• Hypotension;

• Cardiac rhythm below 55 beats per minute;

• Medical conditions that contraindicates the administration of propranolol;

• Previous adverse reaction to, or non-compliance with, beta-blockers;

• Current use of medication that may involve potentially dangerous interactions with propranolol;

• Any medication that can have an impact on cardiac rhythm;

• Women who are breast feeding;

• Past or present bipolar disorder or psychosis,

• Present substance abuse or dependence, suicidal ideation;

• Participating in psychotherapy other than support psychotherapy;

• An average score above 20 on the Dissociative Experience Scale.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Propranolol
1mg per Kg (participant weight)
• Short acting + long acting propranolol + memory reactivation
After completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Verdun	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. Epub 2007 Jun 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromyogram		Two weeks post-treatment	No
Primary	Heart rate		Two weeks post-treatment	No
Primary	Skin conductance		Two weeks post-treatment	No
Secondary	PTSD symptom levels	PTSD symptom levels will be assessed 2 to 26 weeks after randomization	2 to 26 weeks	No
Secondary	Quality of life	Quality of life assessments will be conducted 2 to 26 weeks following randomization	2 to 26 weeks	No
Secondary	Memory Experience	The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization	2 to 26 weeks	No
Secondary	Psychophysiological assessments	Psychophysiological assessments will be repeated 26 weeks following randomization	26 weeks	No

External Links

•   PTSD research website