Reducing Reconsolidation of Trauma Memories With Propranolol

Study Overview
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Brief Summary
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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.

Official Title
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Reduction of the Reconsolidation of the Trauma Memory With Propranolol

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Propranolol
* Drug: Short acting + long acting propranolol + memory reactivation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol + Memory Reactivation<br>This arm involves recalling the traumatic event after administration of propranolol | Drug: Propranolol<br>* 1mg per Kg (participant weight)<br>|
| Experimental: Placebo + Memory reactivation<br>This arm involves recalling the traumatic event after administration of a placebo | Drug: Propranolol<br>* 1mg per Kg (participant weight)<br>|
| Experimental: Placebo + No Memory Reactivation<br>This arm involves administration of a placebo without recalling the traumatic event | Drug: Propranolol<br>* 1mg per Kg (participant weight)<br>|
| Experimental: Propranolol + No Memory Reactivation<br>This arm involves administration of propranolol without recalling the traumatic event | Drug: Propranolol<br>* 1mg per Kg (participant weight)<br>|
| Other: Open-label Propranolol + Memory Reactivation<br>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. | Drug: Short acting + long acting propranolol + memory reactivation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyogram |  | Two weeks post-treatment | 
| Heart rate |  | Two weeks post-treatment | 
| Skin conductance |  | Two weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptom levels | PTSD symptom levels will be assessed 2 to 26 weeks after randomization | 2 to 26 weeks | 
| Quality of life | Quality of life assessments will be conducted 2 to 26 weeks following randomization | 2 to 26 weeks | 
| Memory Experience | The Memory Experiences Questionnaire will be administered from 2 to 26 weeks following randomization | 2 to 26 weeks | 
| Psychophysiological assessments | Psychophysiological assessments will be repeated 26 weeks following randomization | 26 weeks |