Recruiting
Phase 2
Phase 3

Propranolol

Sponsor:

Douglas Mental Health University Institute

Code:

NCT01127568

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Propranolol is available in generic form as the Wyeth product under the trade name Inderal.

Study Details

Brief summary:

Objective: To use propranolol to treat established chronic post traumatic stress disorder (PTSD) by reducing reconsolidation of the reactivated trauma memory.

Hypothesis: A series of treatments with propranolol, in comparison to placebo, will produce a significant reduction in PTSD symptom severity in participants with chronic PTSD.

Study Design: This is a double-blind, placebo-controlled, randomized study. Methodology: Twenty-five participants per group with chronic PTSD will be recruited. On their first visit psychodiagnostic and psychometric evaluation will take place. In addition, script-preparation for the script-driven imagery procedure will occur. Following this, the participants will return each week for a period of 6 weeks to participate in the reactivation sessions with propranolol or placebo (participants assigned to the propranolol condition will receive propranolol throughout, and participants assigned to the placebo condition will receive placebo throughout). Two weeks later, the participants will return for a follow-up of the psychodiagnostic and psychometric evaluation, as well as psychophysiological assessment using script-driven imagery procedure.

Data Analysis: A two-factor analysis of variance (ANOVA) for repeated measures will be performed on study completers. The Drug factor will have two levels: propranolol and placebo. The Time factor will have two levels: pre-treatment and post-treatment. We predict a significant Drug x Time interaction, more precisely a greater decrease in PTSD severity in the propranolol than in the placebo group. The psychophysiological data will be contrasted to a normative cutoff score for PTSD.

Conditions

Stress Disorders, Post-Traumatic

Study ID

NCT01127568

Start date

Feb, 2010

Status verified date

Feb, 2010

Completion date

Jun, 2012

Anticipated

Primary completion date

Sep, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Being between the ages of 18-65
  • Having gone through a potentially traumatic event.

Exclusion Criteria:

  • Not suffering from chronic PTSD
  • Systolic blood pressure <100 mm Hg;
  • Heart rate below 55 beats per minute;
  • Having a medical condition that contraindicates the administration of propranolol, e.g., history of congestive heart failure, heart block, insulin-requiring diabetes, chronic bronchitis, emphysema, or asthma. With regard to asthma, because many persons who say they have had an asthma attack, especially as a child, may only have had hay fever, another allergy, or another non-asthmatic episode, a blanket exclusion criterion may be overly restrictive. Therefore, asthma attacks will only be exclusionary if they a.) occurred within the past 10 years, b.) occurred at any time in life if induced by a β-blocker, or c.) are currently being treated, regardless of the date of last occurrence. Cardiological consultation will be obtained as necessary;
  • Previous adverse reaction to, or non-compliance with, a β-blocker;
  • Current use of a medication that may involve potentially dangerous interactions with propranolol, including, other β-blockers, antiarrhythmics, calcium channel blockers, and potent P450 2D6 inhibitors, e.g., fluoxetine, paroxetine, miconazole, sulconazole, metoclopramide, quinidine, ticlopidine, and ritonavir. Because the protocol does not require to take large doses of propranolol on a daily basis, the decision to exclude participants will be taken by the physician on a case-by-case basis;
  • Pregnancy or breast feeding. Although propranolol can be used during pregnancy we will advise women not to participate in they are or become pregnant. Women breastfeeding will also be advised not to participate because propranolol has been found in human milk. That the quantity absorbed by the breast feeding infant is inferior to 1% of the therapeutic dose (Vidal, 2008).
  • Contraindicating psychiatric condition, including current psychotic, bipolar, melancholic, or substance dependence or abuse disorder; suicidality;
  • Initiation of, or change in, psychotropic medication within the previous 2 months. For participants receiving stable doses of pharmacotherapy, they and their providers will be asked not to change the regimen except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating participation;
  • Current participation in any psychotherapy (other than strictly supportive). Participants will be asked not to initiate psychotherapy during the course of the proposed study except in clinically urgent circumstances; if this becomes necessary, a decision will be made on a case-by-case basis with regard to retaining the participant or terminating participation;
  • Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation;
  • Understanding neither French nor English.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Propranolol

Propranolol is a beta-blocker (blocking beta- adrenergic receptors) that reduces sympathetic activity. It is a well-known drug typically prescribed to individuals suffering from hypertension, tachycardia, cardiac arrhythmia, tremors, thyroid disease, or migraine.

placebo comparator: Placebo

The placebo is an inactive capsule that will have no medication effect, but looks exactly like the medication.

Interventions

Propranolol is available in generic form as the Wyeth product under the trade name Inderal.

The study medication will consist of a dose of 2/3 mg/Kg of short-acting propranolol or placebo, followed 2 hours later by a dose of 1 mg/Kg of long-acting or placebo. The medication will be prescribed by the clinic's physician after medical check-up. A nurse will monitor blood pressure. According to, 40 mg of short-acting propranolol dose should produce a peak blood level of approximately 25 ng/ml at 2 hours, which the additional 60 mg long-acting propranolol should further increase by no more than 5ng. The decay of the blood level induced by the 40 mg short-acting dose after its 2-hour peak will outstrip the further rise induced by the 60 mg long-acting proposal dose, so that blood levels will not rise above this peak 30 ng/ml, which is within the therapeutic clinical range. If the participant tolerates the combination dose without any difficulty, during subsequent sessions, both the short- and long-acting doses will be given together immediately after memory reactivation.

Primary outcome measure

  • Clinician-Administered PTSD Scale (CAPS) for DSM-IV [ Time Frame: Session of Week 0 ]
  • Clinician-Administered PTSD Scale (CAPS) for DSM-IV [ Time Frame: Session of Week 7 ]
  • Clinician-Administered PTSD Scale (CAPS) for DSM-IV [ Time Frame: Session of Week 26 ]

Central Contacts and Locations

Central contacts

Lening A. Olivera Figueroa, Psy.D.

514-761-6131lening.olivera@douglas.mcgill.ca

Nelson Azoulay, B.A.

514-761-6131nelson.azoulay@douglas.mcgill.ca

Locations

Douglas Mental Health University Institute, McGill University

Recruiting

Montreal, Quebec, Canada, H4H 1R3

Principal Investigator:

Alain Brunet, Ph.D.

More Information

Sponsor

Douglas Mental Health University Institute

Last update posted

May 21, 2010

Last verified

Feb, 2010

Keywords

  • Post-Traumatic Stress Disorders
  • Posttraumatic Stress Disorders
  • PTSD
  • Stress Disorder, Post Traumatic
  • Stress Disorders, Posttraumatic
  • Chronic Post Traumatic Stress Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Douglas Mental Health University Institute on 2010-05-21.