Reducing Reconsolidation of Trauma Memories With Propranolol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

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.

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Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propranolol + Memory Reactivation

This arm involves recalling the traumatic event after administration of propranolol

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

1mg per Kg (participant weight)

Placebo + Memory reactivation

This arm involves recalling the traumatic event after administration of a placebo

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

1mg per Kg (participant weight)

Placebo + No Memory Reactivation

This arm involves administration of a placebo without recalling the traumatic event

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

1mg per Kg (participant weight)

Propranolol + No Memory Reactivation

This arm involves administration of propranolol without recalling the traumatic event

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

1mg per Kg (participant weight)

Open-label 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.

Group Type OTHER

Short acting + long acting propranolol + memory reactivation

Intervention Type DRUG

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.

Interventions

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Propranolol

1mg per Kg (participant weight)

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No