PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation

NCT00645450 | Terminated Phase 4 Results DMC

• 1 other identifier: MHBA-013-07S
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stress; Posttraumatic; PTSD; Propranolol; Treatment

Outcome Measures

Primary Outcomes (1)

• PTSD Symptom Severity as Measured by Clinician-Administered PTSD Scale (CAPS)

  CAPS scale measures intensity and frequency of each symptom separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity

  3 years

Study Arms (2)

Propranolol

EXPERIMENTAL

Weekly doses of short and long acting propranolol following recollection of traumatic memory

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Weekly doses of placebo following recollection of traumatic memory

Drug: Placebo

Interventions

Propranolol DRUG

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

Also known as: Inderal, Inderal LA, Hemangeol, Inderal XL

Propranolol

Placebo DRUG

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

Also known as: Inactive pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OEF/OIF veteran diagnosed with combat related posttraumatic stress disorder

You may not qualify if:

• Not diagnosed with current, chronic PTSD
• Current PTSD related to a traumatic event other than the event being treated
• Age\>65.
• Systolic blood pressure \<100 mm HG or resting HR less than 60 BPM.
• Previous adverse reaction to, or non-compliance with a beta-blocker.
• 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.
• Presence of drugs of abuse, viz., opiates, marijuana, cocaine, or amphetamines, as determined by urine testing.
• Pregnancy (in women of child- bearing potential, a pregnancy test will be performed) or breast feeding.
• Contraindicating psychiatric condition, e.g., current psychotic, bipolar, melancholic, or substance dependence or abuse disorder.
• 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.
• 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.
• Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Medical Center, Manchester

Manchester, New Hampshire, 03104, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Scott P. Orr
• Organization: Manchester VA Medical Center

scott.orr@va.gov

603-624-4366

Study Officials

• Scott P Orr, PhD

  VA Medical Center, Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 27, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)