Reducing Reconsolidation of Trauma Memories With Propranolol

Douglas Mental Health University Institute

Status and phase: Unknown; Phase 2

Conditions: Posttraumatic Stress Disorder

Treatments: Drug: Propranolol; Drug: Short acting + long acting propranolol + memory reactivation

Study type: Interventional

Funder types: Other

Identifiers

NCT01349439

08-44

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

76 participants in 5 patient groups

Propranolol + Memory Reactivation

Experimental group

Description:

This arm involves recalling the traumatic event after administration of propranolol

Treatment:

Drug: Propranolol

Placebo + Memory reactivation

Experimental group

Description:

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

Treatment:

Drug: Propranolol

Placebo + No Memory Reactivation

Experimental group

Description:

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

Treatment:

Drug: Propranolol

Propranolol + No Memory Reactivation

Experimental group

Description:

This arm involves administration of propranolol without recalling the traumatic event

Treatment:

Drug: Propranolol

Open-label Propranolol + Memory Reactivation

Other group

Description:

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.

Treatment:

Drug: Short acting + long acting propranolol + memory reactivation