Propranolol Treatment of Traumatic Memories (PTTM)

Not Applicable

• Conditions: Traumatic Memory; Posttraumatic Stress Disorder
• Interventions: Drug: Propranolol Hydrochloride; Drug: Placebo

• Registration Number: NCT01069159
• Lead Sponsor: Mela, Mansfield, M.D.

Brief Summary

This study will compare the responses of subjects with traumatic memories of varying vintages to either propranolol or placebo in a double-blind setting. It is hypothesized that those subjects who receive propranolol will experience less emotional distress when the memory is subsequently reactivated and less spontaneous re-experiences.

Detailed Description

Traumatic memories are responsible for significant emotional distress and disability. They are a cardinal feature of Posttraumatic Stress Disorder (PTSD). Re-experiencing the original traumatic event in a number of different ways (e.g. nightmares, intrusive recollections and dissociative flashbacks) is accompanied by distressing symptoms. The reconsolidation theory of memory proposes that when long-term memories are reactivated, they remain labile for several hours before conversion back to long-term memory. During this period they are susceptible to amnestic agents, like propranolol.

Propranolol Hydrochloride will be compared to placebo in subjects who have emotional distress associated with re-experiences of traumatic events, whether in the context of PTSD or not. Two doses of propranolol or two doses of placebo will be given at the first visit.

The objective of the trial is to determine the effectiveness of brief treatment with propranolol on subjects with traumatic memories and associated symptoms. The research hypothesis is that propranolol will be more effective than placebo, as determined by the measures used, and that this positive outcome will support the reconsolidation theory of memory.

The subjects will undergo clinician rated assessments/scales to determine the presence of pre-treatment mental disorders. Subjects will complete self-rating measures/scales to determine the impact of the traumatic experience. Blood pressure and pulse rates will also be recorded.

Post-treatment outcomes using the same instruments to determine changes at four weeks will be recorded. The differences will be compared and subjected to statistical analysis.

There is an optional component of the study for subjects allocated to the placebo group. At the end of the study, these subjects will be given the opportunity of taking two doses of propranolol and attending a single follow-up session four weeks later for a further interview, rating scale and questionnaire completion. This will provide the subjects who were on placebo an opportunity of possibly benefiting from the active treatment.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-13
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-19
• Last Update Posted: 2011-06-21
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Male or female adults between 18 and 70 years of age
• A traumatic memory, as an isolated symptom or in the context of Post-traumatic Stress Disorder

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Current treatment with either a beta-blocker or a corticosteroid medicine
• Medical contraindications, as outlined in the Compendium of Pharmaceutical and Specialties and the Product Monograph
• Subjects who want to retain every aspect of their memory for the traumatic event, as some memory could be lost

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol	Propranolol Hydrochloride	The protocol of the study requires that two doses of propranolol (regular propranolol 40 mg followed two hours later by long-acting propranolol 60 mg) be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Half of the subjects (33) will be randomized to receive propranolol.
Placebo	Placebo	The protocol of the study requires that two doses of placebo be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Half of the subjects (33) will be randomized to receive placebo.

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be changes between the pretreatment and posttreatment scores in the Clinician Assessment Posttraumatic Scale (CAPS), Impact of Event Scale (IES) and Traumatic Memory Description Measure (TMDM) instruments.	Visit 2 (Week 4)

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint will be changes between the treatment and posttreatment score in the other scales used - MINI, ZAS, ZDS and NIHS.	Visit 2 (Week 4)

Trial Locations

Locations (1)

Knox Manse; 🇨🇦 Saskatoon, Saskatchewan, Canada