PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Propranolol; Placebo
Intervention description: Weekly doses of short and long acting propranolol (Inderal, Inderal LA, Hemangeol, Inderal XL) following recollection of traumatic memory; Weekly doses of placebo (inactive pill) following recollection of traumatic memory
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Stress; Posttraumatic; PTSD; Propranolol; Treatment

Summary:

      This study is a randomized, double-blind, placebo-controlled clinical trial of propranolol
      combined with trauma memory reactivation, to determination if this approach is effective in
      treating PTSD symptoms. Participants will include male and female combat Veterans of the
      Afghanistan and Iraqi wars meeting DSM-IV criteria for chronic PTSD, recruited locally from
      the Manchester VAMC Mental Hygiene Clinic or through advertising. The presence of PTSD will
      be assessed using the CAPS. Participants will be randomly assigned to the propranolol or
      placebo drug condition. During each of six memory reactivation sessions, the participant will
      meet with a psychiatrist, who will ask the participant to spend ten minutes describing the
      event that caused their PTSD, and their reactions to it. The interviewer will facilitate this
      process by asking questions, keeping the participant focused on the traumatic event and
      encouraging him/her to identify aspects of the traumatic event that continue to provoke
      emotional distress. The traumatic memory reactivation will be immediately followed by
      administration of propranolol or placebo. Following the six treatment sessions, script-driven
      imagery will be used to assess HR, SC, and facial EMG responses to recollections of the
      traumatic event and PTSD symptoms will be assessed using the CAPS. A previously developed
      discriminant function will be used to classify each person as a physiologic "responder" or
      "non-responder." There will also be a 6-month follow-up assessment.
    

Eligibility criteria:

        Inclusion Criteria:

        OEF/OIF veteran diagnosed with combat related posttraumatic stress disorder

        Exclusion Criteria:

          1. Not diagnosed with current, chronic PTSD

          2. Current PTSD related to a traumatic event other than the event being treated

          3. Age>65.

          4. Systolic blood pressure <100 mm HG or resting HR less than 60 BPM.

          5. 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 criteria 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
             beta-blocker, or c) are currently being treated, regardless of the date of last
             occurrence. Cardiological consultation will be obtained as necessary;

          6. Previous adverse reaction to, or non-compliance with a beta-blocker.

          7. Current use of medication that may involve potentially dangerous interactions with
             propranolol, including, other beta-blockers, antiarrhythmics, calcium channel
             blockers, and potent P450 2D6 inhibitors, e.g., fluoxetine, paroxetine, micnazole,
             sulconazole, metaclopramide, quinidine, ticlopidine, and ritnavir.

          8. Presence of drugs of abuse, viz., opiates, marijuana, cocaine, or amphetamines, as
             determined by urine testing.

          9. Pregnancy (in women of child- bearing potential, a pregnancy test will be performed)
             or breast feeding.

         10. Contraindicating psychiatric condition, e.g., current psychotic, bipolar, melancholic,
             or substance dependence or abuse disorder.

         11. Initiation of, or change in, psychotropic medication within the previous two months.
             For subjects 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 whether to retain
             the subject in the study or terminate participation.

         12. Current participation in any psychotherapy (other than supportive). Subjects 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 whether to retain the subject in the study or terminate
             participation.

         13. Inability to understand the study's procedures, risks, and side effects, or to
             otherwise give informed consent for participation.