A Novel Treatment For Chronic Posttraumatic Stress Disorder (PTSD) Using Post-Reactivation Propranolol
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Douglas Mental Health University Institute
Collaborators:
Harvard University Massachusetts General Hospital McGill University US Department of Veterans Affairs VA Office of Research and Development