Reducing Reconsolidation of Trauma Memories With Propranolol

Phase 2

• Conditions: Posttraumatic Stress Disorder
• Interventions: Drug: Short acting + long acting propranolol + memory reactivation; Drug: Propranolol

• Registration Number: NCT01349439
• Lead Sponsor: Douglas Mental Health University Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open-label Propranolol + Memory Reactivation	Short acting + long acting propranolol + memory reactivation	All participants terminating the double-blind phase of the study will receive open-label reconsolidation blockade treatment with propranolol combined with recall of the traumatic event for six weeks.
Propranolol + Memory Reactivation	Propranolol	This arm involves recalling the traumatic event after administration of propranolol
Placebo + Memory reactivation	Propranolol	This arm involves recalling the traumatic event after administration of a placebo
Placebo + No Memory Reactivation	Propranolol	This arm involves administration of a placebo without recalling the traumatic event
Propranolol + No Memory Reactivation	Propranolol	This arm involves administration of propranolol without recalling the traumatic event

Primary Outcome Measures

Name	Time	Method
Heart rate	Two weeks post-treatment
Skin conductance	Two weeks post-treatment
Electromyogram	Two weeks post-treatment

Secondary Outcome Measures

Name	Time	Method
PTSD symptom levels	2 to 26 weeks	PTSD symptom levels will be assessed 2 to 26 weeks after randomization
Quality of life	2 to 26 weeks	Quality of life assessments will be conducted 2 to 26 weeks following randomization
Memory Experience	2 to 26 weeks	The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization
Psychophysiological assessments	26 weeks	Psychophysiological assessments will be repeated 26 weeks following randomization

Trial Locations

Locations (1)

Douglas Mental Health University Institute; 🇨🇦 Verdun, Quebec, Canada