Status:
COMPLETED
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Lead Sponsor:
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE4
Brief Summary
This was a six-week pilot study testing the efficacy of tramadol extended-release (ER) for posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related PTSD or PTSD resulti...
Detailed Description
This was a single-site, double-blind, placebo-controlled, randomized, 6-week, parallel-group, flexible-dose outpatient trial of tramadol ER 100-300 mg once every morning for PTSD. Double-blinded clini...
Eligibility Criteria
Inclusion
- Men and women, military veterans and non-veterans, aged 21-55 years
- Active PTSD as determined by diagnostic evaluation and standardized interview (Structured Clinical Interview for the DSM (SCID))
- Literacy and ability to give informed consent
- In women of child-conceiving potential, a negative pregnancy test and use of an approved birth control method
- Glasgow Coma Scale (GCS) score of 15, Extension of GCS with 7-point Amnesia Scale score of 6 (amnesia for traumatic event of 30 min or fewer) or 7 (no amnesia for impact of head) (Nell et al 2000)
- Clinically judged to be at low risk for adverse sequelae from taking tramadol
- Concomitant medications must be approved by the PI
Exclusion
- Pregnant or nursing women
- Homeless persons
- Suicidal or homicidal ideation with plans or intent
- History of opioid dependence or abuse
- Psychosis or history thereof, substance dependence or abuse (other than tobacco dependence; lifetime opioid abuse is exclusionary) within the past 60 days, anorexia nervosa, antisocial personality disorder, or other psychiatric disorder judged by the investigator to be more clinically significant than PTSD
- Serious or unstable illness, endocrinopathy, or metabolic instability, including renal insufficiency, liver disease, hydrocephalus, history of stroke, history of seizures, history of brain tumor
- Use of non-study medications except those approved by the PI
- Newly started in psychotherapy (\< 3months)
- History of hypersensitivity, allergy, or other significant adverse effects from tramadol
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01517711
Start Date
September 1 2011
End Date
August 1 2015
Last Update
August 31 2022
Active Locations (1)
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1
Cincinnati VA Medical Center
Cincinnati, Ohio, United States, 45220