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PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation

NCT00645450 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-07-02

Study results available
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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.

Conditions

  • Posttraumatic Stress Disorders

Interventions

DRUG

Propranolol

Weekly doses of short and long acting propranolol (Inderal, Inderal LA, Hemangeol, Inderal XL) following recollection of traumatic memory

DRUG

Placebo

Weekly doses of placebo (inactive pill) following recollection of traumatic memory

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Scott P Orr, PhD · VA Medical Center, Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00645450 on ClinicalTrials.gov