Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00645450
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00645450
Study Brief:
Protocol Section:
NCT00645450